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Clinical practice guideline for
Surgical site infection: prevention and treatment
of surgical site infection










April 2006

Draft full guideline for consultation
























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National Collaborating Centre for Nursing and Supportive Care



This work was undertaken by the National Collaborating Centre for Nursing and Supportive Care
(NCC-NSC) and the Guideline Development Group (GDG) formed to develop this guideline on behalf
of the National Institute for Health and Clinical Excellence. Funding was received from the National
Institute for Health and Clinical Excellence. The NCC-NSC consists of a partnership between: the
Centre for Evidence-Based Nursing (University of York), the Clinical Effectiveness Forum for Allied
Health Professionals, the Healthcare Libraries (University of Oxford), the Health Economics Research
Centre (University of Oxford), the Royal College of Nursing and the UK Cochrane Centre.

Disclaimer


As with any clinical guideline, recommendations may not be appropriate for use in all
circumstances. A limitation of a guideline is that it simplifies clinical decision-making (Shiffman
1997). Decisions to adopt any particular recommendations must be made by the practitioners
in the light of:
Available resources
Local services, policies and protocols
The patients circumstances and wishes
Available personnel and devices
Clinical experience of the practitioner
Knowledge of more recent research findings.
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Contents 1
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Disclaimer........................................................................................................ 2
Guideline Development Group membership and acknowledgements ............. 5
Terminology..................................................................................................... 7
Abbreviations................................................................................................... 8
1 EXECUTIVE SUMMARY .................................................................... 15
2 PRINCIPLES OF PRACTICE AND SUMMARY OF GUIDELINE
RECOMMENDATIONS....................................................................... 17
2.1.1 Person-centred care ............................................................................. 17
2.1.2 A collaborative inter-disciplinary approach to care................................ 17
2.1.3 Organisational issues.......................................................................... 18
Preoperative phase........................................................................................ 19
Intraoperative phase...................................................................................... 19
Postoperative phase...................................................................................... 22
3.1 Clinical need for the guideline ............................................................. 24
3.2 Definition of SSI .................................................................................. 24
4 AIMS OF THE GUIDELINE................................................................. 27
4.1 Who the guideline is for....................................................................... 27
4.2 Groups covered by the guideline......................................................... 27
4.3 Groups not covered............................................................................. 27
4.4 Healthcare setting ............................................................................... 27
4.5 Interventions covered.......................................................................... 28
4.5.1 Preoperative....................................................................................... 28
4.5.2. Intraoperative...................................................................................... 28
4.5.3. Postoperative Phase (prevention and treatment) ................................ 28
4.6 Interventions not covered.................................................................... 28
4.7 Guideline Development Group............................................................ 29
5.1 Summary of development process...................................................... 30
5.2 Clinical effectiveness review methods................................................. 31
5.3 Cost effectiveness review methods..................................................... 36
5.4 Submission of evidence ...................................................................... 39
5.5 Evidence synthesis and grading.......................................................... 40
5.6 Formulating and grading recommendations........................................ 43
6.1 Preoperative Showering...................................................................... 46
6.2 Preoperative hair removal ................................................................... 51
6.3 Mechanical bowel preparation for elective colorectal surgery............. 67
6.4 (a) Hand decontamination ....................................................................... 72
6.4 (b) Removal of Nail Polish and Finger rings ............................................ 74
6.5 Non-sterile Theatre wear..................................................................... 76
6.6 Surgical Scrubbing.............................................................................. 78
6.7 Sterile Theatre Wear ........................................................................... 83
6.8 Double Gloving.................................................................................... 89
6.9 Face masks......................................................................................... 99
6.10 Preoperative skin antiseptics for preventing surgical wound infection104
6.11 Drapes .............................................................................................. 120
6.12 Perioperative Warming...................................................................... 130
6.13 Perioperative Oxygen....................................................................... 136
6.14 Intra-cavity solutions ......................................................................... 141
6.15 Intra operative skin antiseptics.......................................................... 145
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6.16 Drains for the prevention of surgical site infection............................. 150 1
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6.17 Closure Methods and Materials......................................................... 151
6.18 Wound dressings for surgical sites.................................................... 199
6.19 Clean versus sterile techniques ........................................................ 221
6.20 Postoperative wound cleansing ........................................................ 225
6.21 Dressings and topical agents for surgical wounds healing by secondary
intention Part I ................................................................................... 230
6.22 Dressings and Topical Agents for Surgical Wounds Healing By Secondary
Intention Part II: Toenail Avulsion...................................................... 250
6.23 Pinsite Care ...................................................................................... 256
Methodological quality of included studies................................................... 257
6.24. Treatments for people with surgical site infections ............................. 262
6.25 Patients information needs, experiences, and quality of life issues. 271
Results......................................................................................................... 272
7 RECOMMENDATIONS FOR RESEARCH ....................................... 277
8 Prevention & Management of Surgical Site Infection (SSI) Algorithm279
9 AUDIT CRITERIA.............................................................................. 280
10 DISSEMINATION OF GUIDELINES................................................. 283
11 VALIDATION..................................................................................... 283
12 SCHEDULED REVIEW OF GUIDELINE........................................... 283
13 References........................................................................................ 284


Appendices AG are in separate files.
Part B of the Full Guideline: Separate Appendices
Appendix A: Guideline development Group
Appendix B: Registered Stakeholders
Appendix C: Search Strategies and Searched Data Bases
Appendix D: Tables of Included Studies
Appendix E: Quality Assessment of Studies
Appendix F: Tables of Excluded Studies
Appendix G: Quality Checklists for Economic Studies
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Guideline Development Group membership and acknowledgements 1
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Ms Una Adderley
Tissue Viability Prescribing Specialist Nurse, Malton Hospital, Malton North Yorkshire

Dr Ian Bullock
Director, NCC-NSC

Mr Mark Collier
Lead Nurse/Consultant - Tissue Viability, Pilgrim Hospital, Boston, Lincolnshire

Professor Christopher Dowson
Professor of Microbiology, University of Warwick

Mrs Elizabeth Gibbs
Carer Representative

Mr Chris Jay
Principal Pharmacist Medicines Management, Russell's Hall Hospital Dudley

Mrs Kathryn Kitson
Team Leader - Orthopaedics & Trauma, Bradford Royal Infirmary

Mr Ramon Luengo-Fernandez
Health Economist, Health Economics Research Centre, University of Oxford

Dr Miles Maylor
Consultant Nurse - Tissue Viability, John Radcliffe Hospital, Oxford

Mr Peter Moore
Consultant General Surgeon, Scunthorpe General Hospital

Ms Lakshmi Murthy
Research and Development Fellow, NCC-NSC

Dr Carole Rawlinson
Carer Representative

Dr Eileen Scott
Research Fellow, Centre for Clinical Management Development, University of Durham
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Mr Rick Turnock
Consultant Paediatric Surgeon, Royal Liverpool Children's Hospital

Dr Maggie Westby
Senior Research and Development Fellow, NCC-NSC

Dr Paul Yerrell
Senior Research Fellow, School of Health & Social Care, Oxford Brookes University

Staff at the NCC-NSC who contributed to this guideline:


Ms Jackie Chandler
Research Assistant (to November 2004)

Mr Martin Dougherty
Director (from November 2004 to July 2005)

Ms Elizabeth Gibbons
Research and Development Fellow (to August 2005)

Ms Jenny Gordon
Research and Development Fellow

Ms Elizabeth McInnes
Senior Research and Development Fellow (to October 2005)

Mr Paul Miller
Information Specialist

Ms Emma Nawrocki
Administrator

Mr Edward Weir
Centre Manager




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The NCC-NSC would also like to thank the following people for their assistance
with the guideline:
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Ms Rosa Legood
Health Economist, Health Economics Research Centre, University of Oxford

Dr Jacoby Patterson, Dr Iveta Simera, Dr Lesley Smith
for assistance with systematic reviewing


Terminology

1. Where the term carer is used, this refers to unpaid carers as opposed to paid carers (eg.
careworkers).



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Abbreviations 1
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Technical terms
ARR absolute relative risk
CI confidence intervals
GDG Guideline Development Group
HTA health technology assessment
NNT number needed to treat
RCT randomised controlled trial
RR relative risk

Organizations
DoH Department of Health
MHRA Medicines and Healthcare Products Regulatory Agency (formerly Medical Devices
Agency)
NCC-NSC National Collaborating Centre for Nursing and Supportive Care
NICE National Institute for Health and Clinical Excellence
RCN Royal College of Nursing
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General Glossary 1
2 (partially based on Clinical epidemiology glossary by the Evidence Based Medicine Working
Group, www.ed.ualberta.ca/ebm; Information for national collaborating centres and guideline
development groups, (NICE 2001).
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Absolute risk reduction: The difference between the observed event rates (proportions of
individuals with the outcome of interest) in the 2 groups.

Bias: May result from flaws in the design of a study or in the analysis of results and may result in
either an underestimate or an overestimate of the effect.

Case-control study: A study in which the amount of exposure to a potentially causative factor in a
group of patients (cases) who have a particular condition is compared with the exposure in a similar
group of people who do not have the clinical condition (the latter is called the control group)

Clinical effectiveness: The extent to which an intervention (for example, a device or treatment)
produces health benefits (i.e. more good than harm)

Cochrane Collaboration: an international organisation in which people retrieve, appraise and review
available evidence of the effect of interventions in health care. The Cochrane Database of Systematic
Reviews contains regularly updated reviews on a variety of issues. The Cochrane library contains the
Central Register of Controlled Trials (CENTRAL) and a number of other databases which are regularly
updated and is available as CD-Rom or on the internet (www.cochranelibrary.com)

Cohort study: Follow-up of exposed and non-exposed groups of patients (the 'exposure' is either a
treatment or condition), with a comparison of outcomes during the time followed-up

Co-interventions: Interventions/treatments etc other than the treatment under study that are applied
to the treatment and/or control groups

Co-morbidity: Co-existence of a disease or diseases in a study population in addition to the condition
that is the subject of study

Confidence interval (CI): The range of numerical values within which we can be confident that the
population value being estimated is found. Confidence intervals indicate the strength of evidence;
where confidence intervals are wide they indicate less precise estimates of effects

Cost-benefit analysis: A type of economic evaluation, which estimates the net benefit to society of an
intervention as the incremental (difference in) benefit of the intervention minus the incremental
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(difference in) cost, with all benefits and costs measured in monetary units. If benefits exceed costs,
the evaluation would be a basis for recommending the intervention.

Cost-consequences analysis: A type of economic evaluation, whereby both outcomes and costs of
alternative interventions are described, without any attempt to combine the results.

Cost effectiveness: the cost per unit of benefit of an intervention. In cost effectiveness analysis, the
outcomes of different interventions are converted into health gains for which a cost can be associated.

Cost-of-illness/economic burden studies: An analysis of the total costs incurred by a society due to
a specific disease.

Cost impact: The total cost to the person, the NHS or to society

Cost-minimisation analysis: A type of economic evaluation used to compare the difference in costs
between programs that have the same health outcome.

Costing study: The simplest form of economic study, measuring only the costs of given interventions.

Cost-utility analysis: A type of economic evaluation in which costs and effects of an intervention and
at least one alternative are calculated and presented in a ratio of incremental (difference in) cost over
incremental (difference in) effect. Effects are utility units (e.g. QALYs).

Discounting: the process of converting future pounds and future health outcomes to their present
value

Economic evaluation: comparative analysis of alternative courses of action in terms of both their
costs and consequences

Effectiveness: The extent to which interventions achieve health improvements in real practice
settings

Efficacy: The extent to which medical interventions achieve health improvements under ideal
circumstances

Epidemiological study: A study which looks at how a disease or clinical condition is distributed
across populations, e.g. across geographical areas or over time, or between age groups

Extrinsic: Factors that are external to the individual

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Follow-up: Observation over a period of time of an individual, group or population whose relevant
characteristics have been assessed in order to observe changes in health status or health-related
variables

Gold standard: A method, procedure or measurement that is widely accepted as being the best
available, to which a new method is compared

Health professional: Includes nurses, allied health professionals and doctors.

Health technology assessment: The process by which evidence on the clinical effectiveness and the
costs and benefits of using a technology in clinical practice is systematically evaluated

Incidence: The number of new cases of illness commencing, or of persons falling ill during a
specified time period in a given population

Intrinsic: Factors present within the individual

Logistic regression model: A data analysis technique to derive an equation to predict the probability
of an event given one or more predictor variables. This model assumes that the natural logarithm of
the odds for the event (the logit) is a linear sum of weighted values of the predictor variable. The
weights are derived from data using the method of maximum likelihood

Meta-analysis: A statistical method of summarising the results from a group of similar studies

Number needed to treat: The number of patients who need to be treated to prevent one event.

Odds ratio: Odds (chance) of being exposed in subjects with the target disorder divided by the odds
of being exposed in control subjects (without the target disorder).

Predictive validity: a risk assessment tool would have high predictive validity if the predictions it
makes (say, of pressure ulcer development in a sample) became true (i.e. it has both high sensitivity
and specificity)

Prevalence: The proportion of persons with a particular disease within a given population at a given
time

Quality adjusted life expectancy: Life expectancy using quality adjusted life years rather than
nominal life years (i.e. taking into account not only how long someone lives, but their health state or
level of disability during that time)

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Quality adjusted life years (QALYs): A measure of health outcome which assigns to each time
period a weight, ranging from 0-1, corresponding to the health-related quality of life during that period,
where a weight of 1 corresponds to optimal health, and a weight of 0 corresponds to a health state
judged as equivalent to death: these are then aggregated across time periods

Randomised controlled trial (RCT): A clinical trial in which the treatments are randomly assigned to
subjects. The random allocation eliminates bias in the assignment of treatment to patients and
establishes the basis for the statistical analysis

Relative risk: An estimate of the magnitude of an association between exposure and disease which
also indicates the likelihood of developing the disease among persons who are exposed relative to
those who are not. It is defined as the ratio of incidence of disease in the exposed group divided by
the corresponding incidence in the non-exposed group

Retrospective cohort study: A study in which a defined group of persons with an exposure that
occurred in the past and an appropriate comparison group who were not exposed are identified at a
time later than when they were exposed and followed from the time of exposure to the present, and in
which the incidence of disease (or mortality) for the exposed and unexposed are assessed

Sensitivity: percentage of those who developed a condition who were predicted to be at risk

Specificity: percentage of those correctly predicted not to be at risk

Systematic review: A way of finding, assessing and using evidence from studies (usually RCTs) to
obtain a reliable overview

User: Any one using the guideline

Validity: The extent to which a variable or intervention measures what it is supposed to measure or
accomplish
Internal validity: of a study refers to the integrity of the design
External validity: of a study refers to the appropriateness by which its results can be applied to non-
study patients or populations

Glossary (specific to the guideline):

Antibiotic formulary local policy document produced by the interprofessional team combining best
evidence and clinical judgement

Burst abdomen wound dehiscence of an abdominal incision
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Colony Forming Units (CFUs)- a measure of viable bacterial numbers

Cosmesis: The aesthetic result of a procedure

Erythema: Redness of the skin

Healing by primary intention: The surgeon has closed the wound (e.g. with sutures) so that the skin
will heal up straight away

Healing by secondary intention: The surgeon has left the wound open so that deeper layers heal
before the skin this may be helpful where there is a risk of infection with anaerobic organisms (ones
that survive in an atmosphere without oxygen) as the wound will be exposed to more oxygen and
anaerobic organisms will be discouraged

Infectious extra-abdominal complication: postoperative infectious complication at extra-abdominal
site
Modern Interactive Dressing: Dressings that aim to create the optimum wound healing environment
eg. hydrocolloids, hydrogels, foams, films, alginates and soft silicones

Peritonitis: presence of postoperative infections at the abdominal cavity, localized (abscess)

Wound infection: the presence of pathogenic organisms in a wound giving rise to symptoms, e.g.
fever, purulent discharge

Oedema: Swelling of a tissue due to the accumulation of fluid

Sharp debridement: Small quantities of tissue lying just above the level of viable tissues can be
removed by a clinician in the ward or home environment.

Surgical debridement: The excision or wide resection of all dead or damaged tissues can be carried
out by a clinician in theatre with local or general anaesthetic

Surgical site infection (SSI): A postoperative complication occurring within 30 days following a
surgical procedure. A SSI can occur when bacteria from the skin, other parts of the body or the
environment enter the incision made by the surgeon and multiply in the tissues. This results in physical
symptoms as the body tries to fight the infection. There may be pus, inflammation, swelling, pain and
fever.
Classification of infection is determined by the depth of invasion of micro-organisms. Such
classification is described as:
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Superficial incisional, affecting the skin and subcutaneous tissue.
Deep incisional, affecting the facial and muscle layers.
Organ or space infection affecting any part of the anatomy opened or manipulated during the
operation
A surgical site infection can include wound infection or dehiscence and can be defined as pus, or a
swab with >10 e6 colony forming units (cfu) per mm tissue and at least one of the following signs or
symptoms: pain, localised swelling, redness or heat.

Surgical procedure: A therapeutic procedure involving an incision with instruments

Surgical wound classification:

Clean: An uninfected operative wound in which no inflammation is encountered and in which the
respiratory tract, alimentary, genital, or uninfected urinary tracts are not entered.

Clean-contaminated: Operative wounds in which the respiratory, alimentary, genital, or urinary tract
is entered under controlled conditions and without unusual contamination.

Contaminated: Open, fresh, or accidental wounds; operations with major breaks in sterile technique
or gross spillage from the gastrointestinal tract; and incisions in which acute, non-purulent
inflammation is encountered.

Dirty or infected: Old traumatic wounds with retained devitalised tissue, and those that involve
existing clinical infection.
(National Academy of Science 1964)

Wound dehiscence: Separation of the edges of a wound at a time when the wound would be
expected to be healing








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1 EXECUTIVE SUMMARY
The National Institute for Health and Clinical Excellence (NICE or the Institute)
commissioned the National Collaborating Centre for Nursing and Supportive Care (NCC-NSC)
to develop guidelines on surgical site infection (SSI). This follows referral of the topic by the
Department of Health and Welsh Assembly Government. This document describes the
methods for developing the guidelines and presents the resulting recommendations. It is the
source document for the NICE (abbreviated version for health professionals) and Information
for the Public (patient) versions of the guidelines which will be published by NICE. The
guidelines were produced by a multidisciplinary guideline development group and the
development process was undertaken by the NCC-NSC.
The main areas examined by the guideline were during the:
Preoperative phase
Intraoperative phase
Postoperative phase
This guideline covers areas relevant to the prevention and management of surgical site
infections reflecting the complete patient journey, from preoperative showering to methods of
wound closure to subsequent wound management. The guideline incorporates eight Cochrane
reviews, one Health Technology Assessment report and one Joanna Briggs Institute
systematic review. A total of 1014 studies were assessed, with 178 selected for review. This
involved a total of 58 thousand patients. There were 32 additional health economic studies
included. Recommendations are based on the quality of clinical and cost effectiveness
evidence available. Good practice points are also made based on a combination of evidence
(low grade) and expert opinion that reflects contemporary thinking. The care pathway reflects
a logical sequencing to what is, in effect, tracking the progress of the patient from admission
through to rehabilitation after surgery. This sequencing has enabled the Guideline
Development Group (GDG), supported by the technical team, to look at the evidence reviews,
understand the clinical context and consider the patient voice when shaping guidance to
minimise the risk of acquired infection. Patient experience is at the heart of development, this
representation provides invaluable input to the GDG. Evidence published after January 2006
was not considered.
Healthcare professionals should use their clinical judgement and consult with patients when
applying the recommendations. Recommendations aim to reduce variations in practice, thus
improving patient outcomes related to both the prevention and management of surgical site
infection. This guidance is intended to be the source document for NHS Trust local policy
development. Its success is dependent on the healthcare team owning the challenge of
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reducing SSI. This is centres around the team recognising their part in reducing the incidence
of SSI, minimising patient risk from associated infection, and lowering the actual cost of care to
the NHS. Similar to the associated guideline produced by the Scottish Intercollegiate Guideline
Network on Antibiotic Prophylaxis in Surgery in 1999, the guideline is not intended to provide
every surgical speciality with a comprehensive text on prevention of SSIs, but rather to state
clearly what the evidence is and how this should be interpreted in shaping contemporary
practice. The algorithm (see section 8) enables healthcare professionals, patients and carers
to visualise the care pathway and the application of evidence and good practice points in
determining reduced incidence of SSIs.
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Versions for healthcare professionals (NICE version) and for patients and carers (Information
for the Public) are also available.

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2 PRINCIPLES OF PRACTICE AND SUMMARY OF GUIDELINE
RECOMMENDATIONS
2.1 Principles of practice
The principles, outlined below, describe the ideal context in which to implement the
recommendations contained in this guideline. They reflect original research and development
work previously produced by the RCN, and enable clinicians using evidence based guidance
to contextualise and understand the importance of preparation and planning prior to using this
evidence based tool. Development of a clinical guideline is recognised to be a large
commitment by the group of clinicians, patients, subject specialists and the technical team
responsible for producing evidence sourced recommendations to the NHS in England and
Wales. In understanding the contextual and organisational challenges, a foundation is laid for
the effective implementation of this guidance.
2.1.1 Person-centred care
Patients and carers should be made aware of the guideline and its recommendations
and be referred to the version, Information for Patients and Carers.
Patients and carers should understand decisions made about the management of
surgical site infection, and have the opportunity to ask questions.
Patients and carers should be informed about any potential risks and/or complications of
surgical site infection.
Patients and carers should be informed about the use of appropriate secondary
dressing materials used to augment the primary wound care dressings used in the
treatment of SSI.
2.1.2 A collaborative inter-disciplinary approach to care
All members of the interdisciplinary team should be aware of the guidelines and all care
should be documented in the patients healthcare records.
The approach to care should be an interdisciplinary one involving all appropriate people
in the management of surgical patient care.
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2.1.3 Organisational issues 1
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There should be an integrated approach to the management of surgical site infection with
a clear strategy and policy supported by management.
Care should be delivered in a context of continuous quality improvement, where
improvements to care following guideline implementation are the subject of regular
feedback and audit. This guideline provides opportunity through using the audit tool to
both monitor and inform current practice around the care of SSI.
Commitment to, and availability of, education and training are needed to ensure that all
staff, regardless of profession, are given the opportunity to update their knowledge and
are able to implement the guideline recommendations.
The healthcare team should have undergone appropriate training and have demonstrated
competence in perioperative care.
Staffing levels and skill mix should reflect the needs of patients, and are paramount to
providing high quality services for people who are given preventative treatment for, and
management of an SSI.
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2.2 Summary of guideline recommendations (please refer to section 5 for system
used to grade recommendations).
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Preoperative phase

Preoperative Showering
On the day of surgery, patients should whole body shower with a cleansing agent prior to the clinical
procedure. [B]

Preoperative Hair Removal
On the day of surgery, preoperative hair removal, when clinically indicated, should be undertaken
using clippers. [A]

Single-use clipper heads should be used. [GPP]

Bowel Preparation
The use of preoperative bowel preparation for elective colonic surgery is not recommended. [A]

Intraoperative phase

Hand Hygiene (Part A) Hand Decontamination
The GDG supports the principles of hand hygiene as presented in NICE guideline number 2;
Prevention of healthcare-associated infection in primary and community care.

Hands must be decontaminated immediately before each and every episode of direct patient contact
or care and after any activity or contact that could potentially result in hands becoming contaminated.
[B]

Hands that are visibly soiled, or potentially grossly contaminated with dirt or organic material, must be
washed with liquid soap and water. [A]

Hands must be decontaminated, preferably with an alcohol-based hand rub unless hands are visibly
soiled, between caring for different patients or between different care activities for the same patient.
[A]

Before regular decontamination begins, all wrist and ideally hand jewellery should be removed. Cuts
and abrasions must be covered with waterproof dressings. Fingernails should be kept short, clean and
free from nail polish. [D]

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An effective hand washing technique involves three stages: preparation, washing and rinsing, and
drying. Preparation requires wetting hands under tepid running water before applying liquid soap or an
antimicrobial preparation. The hand wash solution must come into contact with all of the surfaces of
the hand. The hands must be rubbed together vigorously for a minimum of 10-15 seconds, paying
particular attention to the tips of the fingers, the thumbs and the areas between the fingers. Hands
should be rinsed thoroughly before drying with good quality paper towels. [D]

When decontaminating hands using an alcohol handrub, hands should be free form dirt and organic
material. The handrub solution must come into contact with all surfaces of the hand. The hands must
be rubbed together vigorously, paying particular attention to the tips of the fingers, the thumbs and the
areas between the fingers, until the solution has evaporated and the hands are dry. [D]

An emollient hand cream should be applied regularly to protect skin from the drying effects of regular
hand decontamination. If a particular soap, antimicrobial hand wash or alcohol product causes skin
irritation an occupational health team should be consulted. [D]

Hand Hygiene (Part B) - Nail polish and finger rings
Fingernails should be kept clean and short. Nail polish, nail extensions and hand jewellery should be
removed before hand decontamination. [D]

Non-sterile Theatre wear (Scrubs)
Any person who is to be present during a sterile surgical procedure within an operating theatre should
change from civilian clothes and shoes into designated theatre wear (including headwear) before
entering that area. [D]

Consideration should be given to using reusable surgical scrubs in preference to disposable scrubs.
[D]

Surgical Scrubbing
The surgeon, surgical assistant and scrub theatre practitioner should use a scrub technique at the start
of their involvement in the operative list. An alcoholic rub should be used between operations and/or
for dressing changes in a clean environment. [D]

Sterile Theatre wear
The decision to use full, minimal or no sterile surgical attire to protect patients from SSI should be
made after risk assessment, taking into account the nature of the surgical procedure. [D]

Consideration should be given to using disposable gowns in conjunction with disposable drapes. [D]

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Double Gloving
Double gloving should be practised during procedures that have a high risk of glove perforation. [D]

Face Masks
The decision to use face masks to protect patients from SSI should be made after appropriate risk
assessment has been performed, taking into account clinical judgement appropriate to the surgical
procedure. [D]

Face masks can be used for the protection of staff from infection in clinically appropriate surgical
procedures (e.g. orthopaedic surgery). [D]

Preoperative Skin Antiseptics
When choosing to use antiseptics on specific areas of the body (such as mucous membranes),
consideration should be given to known contraindications. Topical iodine should not be used on
neonates and infants. [D]

Aqueous povidone iodine and aqueous chlorhexidine are acceptable skin cleansing agents. Alcohol
based solutions should be used sparingly for safety reasons. [D]

Where clinically indicated, a single application of aqueous povidone iodine is sufficient. [B]

Drapes
Disposable, sterile, single use drapes should be used for sterile surgical procedures that involve an
incision. [D]

Impregnated or non-impregnated incise drapes can be used as the clinician prefers. [D]

Perioperative Warming
In major surgery, the maintenance of normothermia intraoperatively is recommended unless there are
clinical contraindications. [A]

In minor procedures of short duration, systemic or local pre-operative warming is recommended. [A]

Perioperative Oxygen
80% oxygen should be used perioperatively in major surgery except where clinically contraindicated.
[A]

Intracavity Solutions
If clinically indicated, body cavities should be irrigated with warmed (37C), sterile saline. [GPP]
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Intracavity irrigation with dilute solution of povidone iodine in saline is indicated in adult orthopaedic
surgery. [A]

Intraoperative skin antiseptics
Re-disinfection of the wound prior to final skin closure is not indicated. [A]

Closure Methods and Techniques
Skin should be closed with either staples, or a non-absorbable monofilament suture using an
interrupted percutaneous technique. [A]

Tissue adhesives should be used with caution as they are associated with an increased wound
dehiscence rate. [B]

If there are extenuating clinical contraindications, or difficulties are anticipated in the removal of either
staples or sutures (such as in children), consideration should be given to an alternative method of skin
closure, for instance an absorbable subcuticular suture. [D]

The abdominal wall should be closed with an absorbable suture. [A]

Wound Dressings for surgical sites
If a surgical wound healing by primary intention requires a dressing (for exudate management or
protection), a low adherent, modern dressing should be used. [D]

Postoperative phase

Clean versus sterile
The individual patients risk of infection and the reduced cost of a clean dressing technique should be
taken into account by the healthcare professional when deciding whether to use clean or sterile
dressing techniques. [D]

Postoperative Wound Cleansing
Patients can choose to shower from 24 hours postoperatively, unless clinically contraindicated. [B]

Dressings and Topical Agents for wound healing by secondary intention
For dirty or infected wounds healing by secondary intention, polyurethane foam (a modern interactive
dressing) should be used in preference to gauze. [A]

For surgical wounds healing by secondary intention a modern interactive dressing should be used.
Foam, alginate and hydrocolloid dressings should be considered as first-line treatments. [D]

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Toenail avulsion
Following toenail avulsion an alginate dressing (a modern interactive dressing) should be used instead
of gauze. [A]

Other modern interactive dressings can also be considered with an appropriate secondary dressing,
as clinically indicated. [D]

Pin site Care
Pin sites should be kept clean to minimise the risk of infection. This is achieved through assessment
and the weekly removal of dried exudate. Pin sites may be covered with appropriate dressings. [GPP]

Treatments
Any use of an antibiotic for the management of SSIs should be based on information derived from a
clinical assessment process. This includes bacteriological screening (if possible) and referral to an
evidence-based local antibiotic formulary, produced as the result of multidisciplinary work between
clinician, pharmacist and microbiologist. [D]

Patients information needs, experiences, and quality of life issues
Patients undergoing surgery (and their carers) should be fully involved in their care plan and provided
with information on: how to reduce their risk of SSIs; wound management strategies; signs of
postoperative infection. [D]
Health professionals should be aware of the potential implication of a SSI on the physical and mental
wellbeing of patients and their carers. [D]
Patients who develop an SSI should be fully involved in their care plan. Patients experiencing long-
term effects from an SSI should also be given advice and support (e.g. DHSS benefits, transport, OT
aids) to ameliorate those effects. [GPP]
Patients should be fully informed regarding the potential warning signs of infection (local and
systemic). Local signs are an increase in redness, heat, pain, swelling, smell and wound discharge.
Systemic signs include fever. [GPP]
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3 BACKGROUND TO THE CURRENT GUIDELINES 1
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In March 2002, the National Collaborating Centre for Nursing and Supportive Care (NCC-
NSC) was commissioned by NICE to develop clinical and cost effective guidelines on Surgical
Site Infection (SSI). The remit from the DoH and Welsh Assembly Government was to
prepare guidance for the NHS in England and Wales on the prevention, management and
treatment of wounds. This particular guidance within that broad remit relates to surgical
wounds.
3.1 Clinical need for the guideline
The clinical need for evidence based guidance for the prevention of surgical site infection is
perhaps best illustrated by recent trends relating to the surveillance of healthcare-associated
infection, using orthopaedic surgery data in England since April 2004. There has been a
growing need since 1997 for the collection of data to be collected since 1997, with Trusts
volunteering to return data on this particular patient outcome. Surveillance is managed by the
Health Protection Agency on behalf of the Department of Health. A number of surgical
specialities are currently involved in generating this large data base which enables trends to
be established and decisions made regarding patient care. Clearly this process is important in
establishing the size of the problem and in determining the associated costs of addressing the
problem (treatment of SSIs).
3.2 Definition of SSI
SSI is defined as infection related to a surgical procedure that affects the surgical wound or
deeper tissues handled during the procedure. (DoH, 2006)
SSI typically presents as a postoperative complication occurring within 30 days following a
surgical procedure and is an important cause of morbidity and mortality for patients
undergoing surgery. The National Prevalence Survey of Infections in Hospitals (1996),
conducted in 157 hospitals in England, Scotland, Wales and Ireland involving data from
37,111 patients, reported an overall prevalence of hospital-acquired infection of 9.0%. Four
major groups of infections were identified: urinary tract infections; lower respiratory tract
infections; skin infections; and SSIs. The prevalence of SSI was 10.7%. Between 1997 and
2001, the Surgical Site Infection Surveillance Service (SSISS) reported an incidence of SSI of
4.2% from the participating 152 hospitals. Rates of SSI should be interpreted with caution, as
they simply represent estimates based on a sample of all procedures, and typically are from
relatively small data sets which may be imprecise. Data are subjected to normal quality
assurance with confidence intervals stated. That said, in the absence of prevalence studies,
surveillance data is the next best thing to understanding both the range and scope of the
problem.
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In looking at SSI, there are three clear areas of potential cause; these are in the preoperative,
intraoperative and postoperative phases of the patients clinical journey. In preparing for
guideline development, both patient related conditions and operation characteristics were
identified as potential risks of SSI development. In addition, the incidence of infected surgical
wounds may be influenced by factors such as preoperative care, the operating room
environment, postoperative care, the type of surgery, and care in the community.
3.3. Classification of SSI
Classification of the surgical wound is determined by the degree of contamination at the time
of surgery, divided into clean wounds; clean-contaminated wounds; contaminated wounds;
and dirty or infected wounds.
Classification of infection is determined by the depth of invasion of micro-organisms. Such
classification is described as superficial incisional involving the skin and subcutaneous
tissues; deep incisional involving the soft tissues (fascia and muscle); organ/space.
Current data indicate that at any one time, one in ten patients in acute hospitals have a
hospital-acquired infection (HAI) (DoH/PHLS, 1995). Concurrently, an unquantified number of
patients, discharged from hospital into the community have an infection related to their recent
hospital admission. On this basis, SSIs impose a burden on the secondary, tertiary and
primary health-care sectors, community care services, carers and the patients themselves at
significant financial and personal cost. Studies that have estimated the cost of HAI generally
focus on the burden to the hospital sector. Little is known about the costs incurred by the
primary healthcare sector, community care services, individual patients and their family and
friends. In a rapidly developing NHS where surgical advances and changes to service delivery
have typically reduced the inpatient time to a minimum, with over 70% of surgery conducted
as a day case, the full impact of this problem is difficult to estimate.
The Nosocomial Infection National Surveillance Scheme (NINSS), established in response to
the need for a defined programme of surveillance of infection in English hospitals, uses a risk
index (developed by NINSS, Centre for Disease Control, Atlanta USA) to stratify surgical
wound infection rates by risk factors. Risk category is determined by allocating a point for a
contaminated or dirty wound class, and is augmented by both the American Society of
Anaesthesiologists classification and the event of procedures lasting longer than expected for
that particular operation.
3.4 The socio-economic burden of Hospital Acquired Infection (HAI)
In a funded study by the Department of Health (DH), 1449 patients were selected for follow up
into the community following an episode of care (patients undergoing surgery included). The
results from this study showed that 215 patients had an infection identified during the in-
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patient phase. Incidence of acquired infection (one or more infections) was reported as 7.8%
(95% CI: 7.0; 8.6). In the post discharge phase of care 19.1% (95%CI: 16.5; 21.9) of
responding patients who did not have an HAI identified during the inpatient phase and 30%
(95%CI: 22.8; 38.0) of patients who had a HAI identified during the in-patient phase reported
symptoms and treatment that met the criteria for a urinary tract, chest and/or surgical wound
infection.
Hospital costs from HAI incurred during the in-patient phase for those patients presenting with
one or more infections during their in-patient stay were on average, 2.9 times greater than for
patients without infection. This represented an absolute increase of 3154 per case. After
adjusting for the effects of potential confounders the ratio (with/or without) was almost identical
(2.8; 95% CI: 2.6; 3.0), suggesting that confounding had relatively little effect. From the data,
the impact of SSIs was demonstrated to be a cost increase that was two to 2.5 times greater
than for patients who had surgery with no related infection, increasing the cost of the patient
episode on average between 1618 and 2398 per patient.

The co-morbidity impact of SSIs is also demonstrated powerfully in this study. For patients
who acquired more than one infection, costs per patient episode were increased on average,
by 6.6 times when compared to uninfected patients, equivalent to an additional 9152 per
patient episode. Cost impact is an important consideration for the NHS: length of hospital stay
also has a knock on effect for service delivery. Patients who acquired an SSI were (after
adjusting for other factors that might influence length of stay) demonstrated to have an
additional 7 days in hospital.

The argument and rationale is strong for evidence based guidance, combining best available
clinical and cost effectiveness data with expert opinion. Patient experience has demonstrated
an important impact of SSI on quality of life. Together, these provide the fundamental basis for
this timely guidance.

This guideline has been informed by NICE guidance on Infection Control; Prevention of
healthcare-associated infection in primary and community care. NICE Clinical Guideline No. 2
(2003). Available from www.nice.org.uk/page.aspx?o=CG002NICEguideline 31
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4 AIMS OF THE GUIDELINE 1
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To evaluate and summarise the clinical and cost evidence relating to all aspects of the
prevention and treatment of surgical site infection
To highlight gaps in the research evidence
To formulate evidence-based and, where possible, cost-effective clinical practice
recommendations on prevention of surgical site infection based on the best evidence
available to the GDG.
4.1 Who the guideline is for
The guideline is of relevance to all healthcare professionals, health and social care staff that
are involved in the care of surgical patients. This may be within the secondary, tertiary and
primary health-care sectors, community care services, and will provide source material for
both patients undergoing surgery and their carers.
4.2 Groups covered by the guideline
People undergoing a surgical procedure that involves a visible surgical incision, and therefore
results in the presence of a conventional surgical wound (for example, laparotomy, inguinal
hernia and hip replacement surgery). Many general principles of management are
generalisable across the range of surgical procedures routinely performed in the NHS. This
guidance applies to both children and adults undergoing surgery.
4.3 Groups not covered
a) People undergoing a surgical procedure that does not involve a visible surgical incision, and
therefore does not result in the presence of a conventional surgical wound (for example,
vaginal hysterectomy, TURP, and oral surgery). However, many general principles of
management will be generalisable.
b) The guideline will not make recommendations for specific groups of patients at high risk of
developing an SSI or for particular types of surgical intervention.
c) The guideline does not cover lacerations and traumatic wounds
4.4 Healthcare setting
It is recognised that the NHS is rapidly developing patterns of service delivery, with a large
percentage of surgical procedures being performed as day surgery. Minor surgical procedures
are commonly performed in primary care settings such as general practice surgeries. The
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guideline has been developed to cover all current patterns of service delivery, with an
emphasis on raising the awareness of patients and the healthcare team to what they can do to
prevent SSIs.
4.5 Interventions covered
The following interventions will be covered, classified according to the perioperative period
and the nature of the intervention. These are grouped together relative to both the phases of
the surgical procedure and how they relate to the patient and healthcare team.
4.5.1 Preoperative
Patient specific: preoperative showering; preoperative hair removal and bowel preparation.
4.5.2. Intraoperative
Patient specific: preoperative skin antiseptics for preventing surgical wound infections;
perioperative warming; perioperative oxygen; intra-cavity solutions; Intra-operative antiseptics;
techniques and methods of closure (combining sutures and adhesives reviews); toenail
avulsion; wound dressings for surgical sites
Healthcare team: hand hygiene - removal of nail polish and finger rings; theatre wear non
sterile; surgical scrubbing; theatre wear sterile; double gloving; face masks; drapes.
4.5.3. Postoperative Phase (prevention and treatment)
Patient specific: Clean versus sterile techniques; wound cleansing; dressings and topical
agents for wounds healing by secondary intention; pin site care; treatments of infection for
surgical sites; patient views, experiences and information needs
4.6 Interventions not covered
The following interventions will not be covered:
management of antibiotic resistant bacterium
management of the operating theatre environment and environmental factors
4.6.1. Antibiotic anaphylaxis
Clinical guideline evidence on antibiotic prophylaxis in surgery has been produced by the
Scottish Intercollegiate Guidelines Network. This is planned for evidence updating in 2006 and
is expected to be published in 2007.
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4.7 Guideline Development Group 1
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The guideline recommendations were developed by a multidisciplinary and lay Guideline
Development Group (GDG) convened by the NICE-funded National Collaborating Centre for
Nursing and Supportive Care (NCC-NSC) with membership approved by NICE. Members
included representatives from patient groups; nursing; surgical medicine; pharmacy; tissue
viability specialism; microbiology; researchers staff from the NCC-NSC
See Appendix A for GDG membership. The GDG met 12 times between September 2004 and
March 2006. All members of the GDG were required to make formal declarations of interest at
the outset, which were recorded. GDG members were also asked to declare interests at the
beginning of each GDG meeting. This information is recorded in the meeting minutes and kept
on file at the NCC-NSC.
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5 METHODS USED TO DEVELOP THE GUIDELINE 1
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5.1 Summary of development process
The methods used to develop this guideline are based on those outlined by Eccles and Mason
(2001). The structure of the recommendations section (section 6) (ie, recommendations;
evidence statements, evidence narrative and guideline development group commentary) came
from McIntosh et al. (2001).
The stages used in the development of this guideline were as follows:
develop scope of guideline
NICE stakeholder review and feedback
convene multidisciplinary guideline development group
set review clinical questions
identify sources of evidence
retrieve potential evidence
evaluate potential evidence relating to clinical effectiveness, cost/economics and quality
of life, for eligibility, quality and relevance
extract relevant data from studies meeting methodological and clinical criteria
interpret each paper, taking into account the results (including, where reported,
beneficial and adverse effects of the interventions, cost, comfort and acceptability to
patients), the level of evidence, the quality of the studies, the size and precision of the
effect, and the relevance and generalisability of the included studies to the scope of the
guideline
analyse, where appropriate using statistical synthesis, the results reported in the studies
prepare evidence reviews and tables which summarize and grade the body of evidence
formulate conclusions about the body of available evidence based on the evidence
reviews by taking into account the above factors
agree final recommendations and apply recommendation gradings
submit drafts (short version and full version) of guideline for feedback from NICE
registered stakeholders
consider stakeholders comments (GDG)
submit final version of the guideline to NICE.
The main clinical questions addressed were as follows:
1: What are the best methods of patient preparation for the prevention of surgical site
infection (SSI)?
2. What is the most effective method of hand-cleansing by healthcare professionals for the
prevention of SSI?
3. What surgical attire worn by healthcare professionals is most effective for the prevention
of SSI?
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4. What are the most effective surgical techniques for the prevention of SSI?
5. What are the most effective methods of management of a postoperative surgical site?
6. a) Surgical site healing by primary intention
7. b) Surgical site healing by secondary intention
8. c) Infected surgical site

NCC-NSC staff and the health economist (GDG technical team) searched bibliographic
databases for evidence, examined and graded the evidence. The technical team then
composed successive drafts of the recommendations and guideline documents (including the
full version of guideline; the NICE version and the quick reference guide), based on the
evidence reviews and GDG input and deliberations. The GDG formulated and initially graded
the recommendations. The NICE patient and public involvement programme produced the
information for the public version, using the NICE version of the guideline, in collaboration with
the NCC-NSC. The decision relating to the removal of graded recommendations was taken by
the NICE Executive Board, coming into effect from April 1
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2006. This was discussed by the
GDG who agreed to present recommendations in this guideline without letter grading in the
NICE version. This version keeps the letter grading for the purpose of clarity in demonstrating
the linear relationship between evidence review, levels of evidence, recommendation
development and grading.
The general methods for the evidence reviews are reported in sections 5.2 and 5.3. This linear
relationship, demonstrating the relationship between the clinical and cost effectiveness results,
evidence statements and resulting recommendations, is reported for each review in sections
6.1 to 6.24.
The search strategies for the reviews are presented in Appendices C1 to C24. The included
studies for each review are reported in Appendices D1 to D24; the methodological
assessments of the included studies are in Appendices E1 to E24 and the studies excluded
from each review are listed in Appendices F1 to F24.
5.2 Clinical effectiveness review methods
5.2.1 Selection criteria
The following selection criteria were applied to studies to determine their suitability for
inclusion in the reviews:
Types of studies
Randomised trials (RCTs) comparing interventions for the prevention or management of SSI.
Where there were no randomised trials, we included quasi randomised designs (e.g. allocation
by systematic methods such as alternation, date of birth).
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The types of studies included for the review on patients information needs, experiences and
quality of life issues, range from randomised trials to qualitative phenomenological
approaches.
Types of participants
Adults and children undergoing an incisional surgical procedure, including a surgical implant.
Types of intervention
The interventions varied across reviews and are detailed at the beginning of each results
section.
Types of outcome
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For prevention:

Primary outcomes

Rates of surgical site infection, defined as a postoperative complication occurring within
30 days following a surgical procedure. Indications for SSI include: pus, or a swab with
more than 1 million ( >10
6
) colony forming units (cfu) per mm tissue and at least one of
the following signs or symptoms: pain, localised swelling, redness or heat (Mangram
1999). The GDG did not consider studies for which the time of registering wound
infections was less than seven days. This decision to exclude evidence reporting <7 days
postoperatively was based on clinical judgement, due to the uncertainty that the cause of
the infection was surgery related.

In some studies, other outcomes were measured, which could be construed as surrogates for
SSI. Generally surrogate measures are used when it is impossible or impractical to measure
the true outcome. For validity there is a need to have independent evidence of correlations
between the surrogate and desired outcome measures. The GDG discussed whether there
were any acceptable surrogate outcomes for SSIs. They decided that, as it is usually possible
to measure the rate of SSI, surrogate outcomes could be taken into account only to advise
GDG consensus decisions (with the recommendation being graded as D or GPP). The
following surrogates were considered, but there was some doubt about their validity:
Causal bacteria (cfu counts)
Number of perforations (gloves)
Wound inflammation was not considered to be a surrogate for SSI.

35
36
37
38
39
Secondary Outcomes
Rate of healing (including time to complete healing, rate of change in the area/volume of
the wound)
Wound dehiscence / stitch abscess
Depth of infection (deep / superficial)
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Length of hospital stay
Mortality rate due to SSI
Adverse effects (e.g. toxicity, allergies, pain)
Incidence of septicaemia
Postoperative antibiotic use
Re-admission to hospital
Patient satisfaction
Healthcare professional satisfaction

In addition, other secondary outcomes were reported that allowed assessment of the
intervention in its full context, but were not usually related to infection and/or were specific for
particular reviews. These included:
Anastomotic leakage (bowel preparation)
Re-operation (bowel preparation)
Infectious extra-abdominal complication (bowel preparation)
Staff acceptability (theatre attire)
Acceptability of finger ring removal (nail polish)
Absorbency (theatre attire)
Ease of handling (theatre attire)
Incisional hernia (methods of closure)
Cosmetic appearance (methods of closure)
Ease of removal (methods of closure, dressings)

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For postoperative prevention and treatment
Primary outcome
Rate of healing (time to complete healing; proportion of wounds healed in a specified time
period; rate of change in the surface area/volume of the wound)

Secondary outcomes
Infection cure or improvement rates any objective or subjective measure as defined by
the study authors. This may include subjective assessments of pain, pus, swelling,
redness or heat
Pain
Exudate
Scarring
Ease of removal (dressings)
Complications and morbidity
Mortality
Patient related outcomes: comfort, satisfaction, acceptability of the intervention
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Length of stay
Quality of life data: generic or specific measures of quality of life
Number of carer visits
Re-admission rates

5.2.2 Search Strategy
search terms (can refer to Appendix)
databases
dates

The search strategies and the databases searched are presented in Appendix C. All searches
were comprehensive and included a large number of databases. All search strategies were
adapted for smaller or simpler databases or for web-based sources which did not allow
complex strategies or multi-term searching.
A combination of subject heading and free text searches were used for all areas. Free text
terms were checked on the major databases to ensure that they captured descriptor terms and
their exploded terms.
Hand-searching was not undertaken following NICE advise that exhaustive searching on every
guideline review topic is not practical and efficient (Mason et al. 2002).
Reference lists of articles were checked for articles of potential relevance.
5.2.3 Sifting process
Once articles were retrieved the following sifting process took place:
1st sift: Sift for material that potentially meets eligibility criteria on basis of title/abstract
by one reviewer;
2nd sift: Full papers ordered that appear relevant and eligible or where
relevance/eligibility not clear from the abstract;
3rd sift: Full articles are appraised that meet eligibility criteria.
5.2.4 Data abstraction
Data from included studies were extracted by one reviewer for each review into pre-prepared
data extraction tables. The following data were extracted from each study:
patient inclusion/exclusion criteria
care setting
key baseline variables by group
description of the interventions and numbers of patients randomised to each intervention
description of any co-interventions/standard care
duration and extent of follow up
outcomes measured and results
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acceptability and reliability if reported
If studies were published more than once, the most detailed report was used as the basis of
the data extraction
Masked assessment, whereby data extractors are blind to the details of journal, authors etc,
was not undertaken because there is no evidence to support the claim that this minimises bias
(Cullum et al, 2003).
Once individual papers were retrieved, the articles were checked for methodological rigour
(using quality checklists appropriate for each study design), applicability to the UK and clinical
significance. Assessment of study quality concentrated on dimensions of internal validity and
external validity. Information from each study that met the quality criteria was summarised and
entered into evidence tables.
5.2.5 Appraisal of methodological quality
The methodological quality of each trial was assessed by one reviewer and checked by the 13
senior research fellow. The following quality criteria were used: 14
15 description of a priori sample size calculation
16 description of method of generation of the randomisation sequence
17 evidence of allocation concealment at randomisation
18 description of baseline comparability of treatment groups
19 outcome assessor stated to be blinded
20 evidence that loss to follow up for each outcome was not more than 20% for each group
for the outcome of rate of SSI, evidence that recordings were made not less than seven 21
days post-operatively 22
23 5.2.6 Data synthesis
Some areas of the guideline were the subject of Cochrane Reviews, for these updating and re- 24
analysis was carried out as necessary. We conducted meta-analyses, where appropriate, for 25
other topics. 26
Meta-analysis of similar trials, where appropriate, was carried out using The Cochrane 27
Collaborations analysis software, Review Manager (Version 4.2). Trials were pooled using a 28
fixed effects model and plotted on forest plots. 29
Where it was possible to combine studies, outcomes were summarised for dichotomous data 30
using odds ratios (as default), relative risks (where the event rate was greater than 20%), or 31
Peto odds ratios (where there were studies with no events) For continuous data, weighted 32
mean differences for continuous data. Summary statistics and their 95% confidence intervals 33
(95% CI) were reported where sufficient detail allowed their calculation. 34
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We assessed heterogeneity between trials by visual inspection of forest plots, noting where 1
there was poor overlap of horizontal lines, and by using statistical measures: the
2
test for 2
heterogeneity and the level of inconsistency, I
2
(I
2
= [(
2
df)/
2
] x 100%, where df is the 3
degrees of freedom). We considered that there was heterogeneity if p<0.1 and/or

I
2
>50%. Any 4
heterogeneity was explored further and unexplained heterogeneous results were not used as 5
the basis for recommendations. 6
Subgroup analyses were carried out in order to investigate heterogeneity; the following 7
general pre-specified factors were investigated: 8
9 Nature of surgery (clean, clean-contaminated, contaminated, dirty).
10 Subgroup analyses specific to each review were also carried out.
For the guideline analyses, we did not combine truly randomised trials and quasi-randomised 11
trials (e.g. sequence generation by alternate allocation or by date of birth) in a meta-analysis - 12
where both types of design were present, we excluded the quasi-randomised studies from the 13
analysis, as they represented a potentially higher risk of bias. Other studies that were 14
potentially biased were those with large numbers (more than 20%) of withdrawals or protocol 15
deviations in any group (that were eliminated from the studys analyses). Where quasi- 16
randomised studies represented the only evidence, they were analysed separately and graded 17
accordingly. 18
Some meta-analyses gave pooled summary statistics close to the null value. Where the 19
confidence interval was narrow, we considered this to be evidence for little difference 20
between interventions and the approach became similar to that of an equivalence trial 21
(Alderson 2004). Where the confidence interval was wide, there was considered to be 22
insufficient information to determine if there was a difference between interventions. For most 23
outcomes, the GDG judged what constituted a wide confidence interval; if there was any 24
doubt, they decided there was uncertainty. For the continuous outcome, length of stay in 25
hospital, the GDG decided that a confidence interval of greater than 14 days should be 26
considered to be wide. 27
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33
34
5.3 Cost effectiveness review methods
5.3.1 Background
The aims of the review were to:
1. Identify publications assessing the cost of surgical site infections in the UK
2. Identify economic evaluations of intervention for the prevention and/or treatment of
surgical site infections covered by the guideline. By definition an economic evaluation
compares the costs and outcomes of at least two health interventions;
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2
3. Find studies with relevant resource use and cost data to facilitate possible cost-
effectiveness
The health economics glossary provides more information on the different types of economic 3
study. 4
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5.3.2 Selection criteria
For selection of relevant health economics evidence, the following criteria were used:
Only those studies in the English language were included in the review.
No restriction was placed on publication status of papers.
Year of publication restrictions were identical to the clinical literature review section.
Selection criteria based on clinical conditions, patients, interventions and settings were
identical to the clinical literature review section.
All types of economic evidence were considered for inclusion, regardless of clinical study
design. However, this was subject to the study providing sufficient details on methods and
results to enable judgement of the quality of the study.

For studies evaluating the costs of surgical site infection, only studies within a UK setting were
included in the review. However, to identify other health economics information relevant to a
UK setting economic evaluations from OECD countries or member states of the European
Union were included in the review.
5.3.3 Search strategies for reviews of economic evaluations, costing studies
Several health economic databases were searched for studies that evaluated any intervention
for SSI. These were NHS EED (NHS Economic Evaluation Database), OHE HEED (Office of
Health Economic Evaluations Database), HTA (Health Technology Assessment), and DARE
(Database of Abstracts of Reviews of Effectiveness). No date limit was applied to these
searches.

Medline, Embase and Cinahl were searched using a combination of a specially developed
health economics search filter combined with the clinical search terms for each topic assessed
in the guideline. However, where the clinical search strategy used terms to identify particular
study designs (e.g. randomised trials) we omitted these restrictions in our search strategy The
same search dates used in searching for the clinical evidence were used in the searches for
economic evidence.

The search strategies and the databases searched are presented in Appendix C.

5.3.4 Sifting process
Titles and abstracts of all references were checked to identify papers of potential relevance.
The full texts of all potential eligible studies or for those studies where relevance and/or
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eligibility was not clear from title and abstract were obtained. All full texts obtained were then
tested by the health economist against the selection criteria detailed below.

All those papers included in the review were then quality assessed using the British Medical
Journal checklist for economic evaluations (Drummond and Jefferson, 1996), and a shortened
version of this checklist in the case of costing studies.

5.3.5 Data abstraction
9 For the cost effectiveness studies, the following data were abstracted by a single abstractor:
10 details of the study design;
11 details of the study population;
12 details of the intervention;
13 details of individual outcome measures used
14 details of and source of effectiveness data in economic models, for example, RCT;
15 methods of collecting cost data - for example, micro level costing;
16 assumptions made by authors developing economic models;
17 estimates of the cost effectiveness and range;
18 generalisability to the UK context.
19 For the cost studies, the following data were abstracted by a single abstractor:
study design or source of information, reference, date and potential problems with 20
source; 21
22 perspective of costing;
23 intervention costed;
24 estimate of cost and range;
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29
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31
32
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34
35
36
37
generalisability to the UK setting.
5.3.6 Further economic modelling
There were a number of topics in the guidelines where there was only limited economic
evidence available. However, as the guideline has a broad scope it was not possible within the
time frame to provide an economic model for all topics. Areas requiring further economic
analysis were identified by the health economist in conjunction with the Guideline
Development Group (GDG) members. Topics for modelling were prioritised according to the
following criteria:

The resource implications to the NHS of the proposed health intervention;
Challenge current clinical practice;
Lack of consensus amongst clinicians on interventions to follow;
Sufficient data to allow for useful modelling; and
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Any other factor deemed relevant by the GDG member.

Modelling was undertaken for the following areas of the guideline: preoperative antiseptics,
preoperative hair removal, surgical face masks, and double gloving. The methods and data
used for these economic models are reported in each evidence review (sections 6.1 to 6.25).
The quality checklists for economic studies are given in Appendix G.

5.4 Submission of evidence
Stakeholders registered with NICE (see Appendix B) were invited to submit a list of evidence
for consideration to ensure that relevant material to inform the evidence base was not missed.
The criteria for the evidence included:
systematic reviews
randomised trials (RCTs) that examine clinical or cost effectiveness, and/or quality of life
and economic analyses based on these findings
representative epidemiological observational studies
qualitative studies/surveys that examine patient/carer experiences
studies of any design which have attempted to formally:
assess the cost effectiveness/utility of interventions for the prevention or
management of SSI
assess the cost of having a surgical site infection
assess quality of life or used cost-utilities in relation to surgical site infections
Information not considered as evidence included:
studies with weak designs when better studies are available
commercial in confidence material
unpublished secondary endpoint trial data, data-on-file and economic modelling
promotional literature
papers, commentaries or editorials that interpret the results of a published study
representations or experiences of individuals not collected as part of properly designed
research

Initial submissions were received from:
ConvaTec
Johnson & Johnson Medical
Kimberley Clark
Smith & Nephew Healthcare

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2
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6
7
8
All references were screened for relevance and design criteria and those considered eligible
were checked with our databases to ensure our search had captured such studies.

5.5 Evidence synthesis and grading
Evidence gradings were assigned to each evidence review using the evidence hierarchy
shown below (Table 2). This hierarchy is recommended for intervention studies by NICE at the
time of writing. Studies or meta-analyses with a minus rating were not used as a basis for
recommendations.
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1 Table 2: Levels of evidence
Level of
evidence
Type of evidence
1
++
High-quality meta-analyses, systematic reviews of RCTs, or
RCTs with a very low risk of bias

1
+
Well-conducted meta-analyses, systematic reviews of RCTs,
or RCTs with a low risk of bias

1

Meta-analyses, systematic reviews of RCTs, or RCTs with a


high risk of bias
*

2
++
High-quality systematic reviews of casecontrol or cohort
studies.

High-quality casecontrol or cohort studies with a very low
risk of confounding, bias, or chance and a high probability
that the relationship is causal

2
+
Well-conducted casecontrol or cohort studies with a low risk
of confounding, bias, or chance and a moderate probability
that the relationship is causal

2

Casecontrol or cohort studies with a high risk of confounding


bias, or chance and a significant risk that the relationship is
not causal*

3 Non-analytic studies (for example, case reports, case series)

4 Expert opinion, formal consensus

2

*
Studies with a level of evidence - should not be used as a basis for making a recommendation.

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33
We found it necessary to interpret the ratings for bias, and included the following general
approaches:
1. Studies that had a quasi-randomised method of allocation were regarded as
potentially biased, but were rated as 2+ (rather than 1- ). We gave this assignment to
studies in this guideline, because we believed that such studies were comparable with
good cohort studies. However, these quasi-randomised studies were not combined
with randomised trials in meta-analyses, and were generally not considered when
there were higher quality randomised trials.
2. We regarded randomised trials with at least 20% of data missing from any group as
potentially biased, and gave these trials an evidence level of 1- . Moderate loss to
follow up (20-50%) were considered in sensitivity analyses, but those with 50% or
more patients missing from any one group were regarded as flawed and not analysed
further.
3. Single studies or meta-analyses that had wide confidence intervals or heterogeneity
were also regarded as potentially biased, this time giving a type II error (representing
the uncertainty about measuring the true effect). We gave these studies or meta-
analyses an evidence rating of 1-.
4. We gave a level of 1+ to meta-analyses of a small number (3 or less) of randomised
trials (unless there was heterogeneity). Meta-analyses of more than 3 trials were rated
1++.
5. Where the evidence was contained in a single randomised study, we assigned a level
of 1+ unless the trial was large (n>200) and of high quality (in which case the level
was 1++), and we were cautious if the study size was less than 20.
6. Single studies or meta-analyses including studies for which the data were extracted
from a graph were given a level of 1+, reflecting the uncertainty which may arise from
this method of data extraction.
The evidence tables and reviews were distributed to GDG members for comment on the
interpretation of the evidence and grading. Factors taken into consideration when grading the
evidence were the study design, quality assessment and the uncertainty in the effect estimate
(confidence interval).
In addition to the evidence garde described above, the evidence was described as good, fair,
weak and insufficient, as ahown in table 3.

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1 Table 3: Evidence descriptions
Good (robust; strong) evidence was defined as mainly several good quality RCTs
and/or meta-analyses or a single large RCT, which consistently reported statistical
significance of effectiveness in favour of an intervention/therapy for the
prevention/treatment of SSI. Conversely, this type of evidence could consistently
provide robust evidence that there is no statistical difference between two
interventions.
Fair (some; moderate) evidence was defined as single RCTs which consistently
reported statistical significance of effectiveness in favour of an intervention/therapy for
the prevention/treatment of SSI. Conversely, this type of evidence could consistently
provide fair evidence that there is no statistical difference between two interventions.
Limited (weak, insufficient) evidence was defined as RCTs that had small sample
sizes and/or high risk of bias.
Inconsistent evidence was defined as when study results conflicted (that is there
were inconsistencies between studies in terms of the direction of effect or whether
there was an effect or not).
2
The data from included studies pertaining to costs, economic evaluation, epidemiology and 3
quality of life were also qualitatively synthesised into a narrative format. Information from the 4
reviews on costs, economic evaluations and epidemiology was used in the economic 5
modelling. All included studies are summarized in evidence tables (Appendices D) as well as 6
discussed in the appropriate evidence reviews. 7
8
9
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12
13
14
15
16
17
18
19
20

5.6 Formulating and grading recommendations
In order for the GDG to formulate a clinically useful recommendation, it was agreed that the
following factors be considered:
The best available evidence with preference given to empirical evidence over expert
judgement, including:
effectiveness data taking into account the strength of evidence (the level, quality,
precision ) as well as the size of effect and relevance of the evidence
where reported, data regarding additional outcomes such as comfort, adverse effects
and patient acceptability
A comparison between the outcomes for alternative interventions where possible
a profile of the cost data
results of economic modelling
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23
The feasibility of interventions, including the cost of the intervention, acceptability to
clinicians, patients and carers and appropriateness of device.
The balancing of benefits against risks - including, where reported, all patient-relevant
endpoints (including adverse effects; comfort and acceptability where reported) and the
results of the economic modelling.
The applicability of the evidence to groups defined in the scope of the guideline, having
considered the profile of patients recruited to the trials and data obtained from our review
of the epidemiological data and quality of life literature.
This information was presented to the group in the form of evidence tables and accompanying
summaries which were discussed at GDG meetings. Where the GDG identified issues which
impacted on considerations of the evidence and the ability to formulate implementable and
pragmatic guideline recommendations, these were summarised in the GDG commentary
sections.
Issues with the data, interpretation of the evidence and the wording were discussed until there
was agreement on the wording and grading.
Where the GDG decided that hard evidence was essential before any recommendations
could be considered, recommendations for future research were made (see section 7). The
group then ranked these in order of importance so that the top 5 could be included in the NICE
version.
The grading of the recommendations was agreed at a GDG meeting using the scheme in table
4.


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Table 4: Grades of recommendations

Grade Evidence
A At least one meta-analysis, systematic review, or RCT rated as 1++, and
directly applicable to the target population, or
A systematic review of RCTs or a body of evidence consisting principally
of studies rated as 1+, directly applicable to the target population, and
demonstrating overall consistency of results
Evidence drawn from a NICE technology appraisal
B A body of evidence including studies rated as 2++, directly applicable to
the target population, and demonstrating overall consistency of results, or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the
target population and demonstrating overall consistency of results, or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4, or
Extrapolated evidence from studies rated as 2+, or
Formal consensus
D(GPP) A good practice point (GPP) is a recommendation for best practice based
on the experience of the GDG
3
4
5



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6 GUIDELINE RECOMMENDATIONS WITH SUPPORTING
EVIDENCE REVIEWS
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6.1 Preoperative Showering

Objective

To determine the clinical and cost-effectiveness evidence for preoperative bathing or showering with
antiseptics for the prevention of surgical site infection.

Criteria for considering studies for this review

Types of comparison
Any type of antiseptic solution (any strength, any regimen at any time before surgery) used for
preoperative tub or bed bathing or showering compared with:
non-antiseptic soap
non-antiseptic soap solution,
No shower or bath.

Antiseptic solutions are defined as liquid soap products containing an antimicrobial ingredient such as
chlorhexidine, triclosan, hexachlorophene, povidone iodine or benzalkonium chloride. Trials comparing
different types of antiseptic with each other were compared if the evidence for the benefit of showering
is either equivocal or if there is evidence of benefit with showering with antiseptic.

Search Strategy
Details of the general approach to searching are reported in Section 5.3. The search used for this
review is given in Appendix C1.

Characteristics of studies included in the clinical review (Appendix D1)
Of the 49 potentially eligible studies, four studies were included (Wihlborg 1987; Rotter 1988;
Earnshaw 1989; Byrne 1992). Reasons for exclusion are listed in Appendix F1.

There were a total of 6,831 patients in the four studies undergoing a range of types of surgery
including: vascular reconstructions (Earnshaw 1989); inguinal hernia and breast cancer (Wihlborg
1987); thyroidectomy, inguinal herniorrhaphy, hip or knee joints, mastectomy (Rotter 1998). Types of
surgery were not listed in Byrne 1992.

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There were two studies conducted in the UK (Byrne 1992; Earnshaw 1989), one in Sweden (Wihlborg
1987), and one stated it was a multinational European study (Rotter 1988).

The comparisons examined in the studies were as follows:
Whole body washing with chlorhexidine against a placebo preparation (Byrne 1992).
Chlorhexidine versus non-medicated soap.(Earnshaw 1989)
Chlorhexidine versus detergent that did not include chlorhexidine. (Rotter1988)
Whole body chlorhexidine versus chlorhexidine on only the body part for operation (Wihlborg
1987)
Whole body chlorhexidine versus no washing (Wihlborg 1987)

All four studies reported on wound infection as an outcome, but there were different definitions of
infection and measured at varying times. Wound infection was defined as defined as discharge of pus
from a wound (Byrne 1992) and was assessed at 14 days; discharge of pus or severe cellulitis
assessed until time of discharge and at one month period (Earnshaw 1989); inflammation with
discharge of pus assessed at 21 days after discharge from hospital (Rotter 1988) and definite
collection of pus emptying itself spontaneously or after incision (Wihlborg 1997). Timing of assessment
was unclear in Wihlborg (1987).

Characteristics of included studies in the cost effectiveness review (Appendix
D1)
Only one published study (Lynch 1992) was identified in the review. This study was an economic
evaluation using clinical and resource use data from the same study as Byrne (1992) which was
included in the clinical review.

Methodological quality of included studies in the clinical review (Appendix E1)
The method of randomisation was adequate (computer generated) in two of the studies (Rotter 1988;
Byrne 1992) and unclear in the (Earnshaw 1989) and (Wihlborg 1987) in which patients were
randomised to wards.

Concealment was adequate in two of the studies (Wihlborg 1987; Rotter 1988;) and unclear in two
(Byrne 1992; Earnshaw 1989).

Two trials reported double blinding (Rotter 1988; Byrne 1992), one trial reported no blinding (Wihlborg
1987) and one trial was unclear on method of blinding (Earnshaw 1989).

Three trials reported confirmed blinding of outcome assessors (Wihlborg 1987; Rotter 1998; Earnshaw
1989). In one trial blinding was not possible as wound surveillance was at the ward where wash
method would be known (Wihlborg 1997) and one trial did not state it (Byrne 1992).

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A priori calculations were not performed in any of the studies. Withdrawals were reported in three
studies as follows: 5% (Rotter 1988) and 7% (Wihlborg 1987; Rotter 1988).

Baseline comparability was stated in two studies (Wihlborg 1987;Rotter 1988). However, the Whilborg
(1987) study did not provide information on comparability of wards, therefore it may be confounded.

Methodological quality of included studies in the cost-effectiveness review
The costing analysis in Lynch (1992) had several limitations. First of all, some important costs such as
the costs of the detergent used for disinfection were not included in the analysis; secondly, outpatient
costs were only included for the last 2,000 patients randomised in the study; and finally, but most
importantly, the authors did not report if differences in mean costs between the two groups were
statistically significant.

Results
Two studies compared chlorhexidine with detergent versus detergent alone (Byrne 1992; Rotter 1988).
Earnshaw (1989) compared chlorhexidine with non-medicated soap. Wihlborg (1987) had three groups
of patients: one used whole body chlorhexidine shower; one used chlorhexidine soap on only the body
part for operation; the third group used no chlorhexidine (and no washing).

A comparison of whole body chlorhexidine showering versus no showering (Wihlborg 1987) showed
significantly less infection with whole body showering to either no shower (RR .36 95%CI .16, .78) or
to part body chlorhexidine soap (RR .39 95% CI .18, .85); (Figure 1).

A meta-analysis of two studies comparing chlorhexidine with detergent versus detergent (Rotter 1988;
Byrne 1992) showed no significant difference between the two comparisons. (Figure 1).

A comparison of rinsing with chlorhexidine (full body paint with undiluted antiseptic) versus non
medicated soap (Earnshaw 1989) showed no significant difference between the two comparisons.
However, the confidence interval is fairly wide to draw any definite conclusions. (Figure 1).











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Figure 1


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Cost-effectiveness
One study was identified comparing a chlorhexidine detergent shower three times before elective
surgery with three showers using placebo detergent. The average cost of both non-infected and
infected patients was found to be higher in the chlorhexidine than the placebo group. The average cost
of non-infected chlorhexidine patient was 847.95 as opposed to 804.60 for a non-infected placebo
patient, whilst the average cost of an infected patient was 1459.70 (chlorhexidine) and 1414.22
(placebo). The authors concluded that preoperative whole-body disinfection with a chlorhexidine
detergent was not a cost-effective treatment for reducing wound infection.

GDG Commentary
On the day of surgery, if the patient has not showered, the health care professional should facilitate
this where clinically appropriate.









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3
Evidence statements and recommendations

Level of
Evidence
Evidence Statements
1+ There is fair evidence to suggest that whole body showering with chlorhexidine
reduces surgical site infection rates compared with no showering or part
washing with chlorhexidine

1++

There is good evidence to suggest that there is no significant difference in
surgical site infection rate between chlorhexidine with detergent versus
detergent alone.

1- There is insufficient evidence to determine whether there is a significant
difference in surgical site infection rate between rinsing with chlorhexidine
versus non medicated soap.

4 On the day of surgery, if the patient has not showered, the health care
professional should facilitate this where clinically appropriate


Health Economics Evidence Statement
There is some evidence to indicate that pre-operative showering with a
chlorhexidine detergent is not a cost-effective intervention to prevent surgical
site infections when compared to pre-operative showering with a placebo
detergent




Grade

Recommendation
B


On the day of surgery, patients should whole body shower with a cleansing
agent prior to the clinical procedure.

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6.2 Preoperative hair removal 1
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Objective
The aims of this review are two fold. The first aim is to examine if pre-operative hair removal is
necessary and cost-effective, and the second is to examine the effects of hair removal on surgical site
infection.

Criteria for considering studies for this review
Types of comparisons
This review will include comparisons between any of the following:
No pre-operative hair removal
Wet shaving
Dry shaving
Clipping
Depilatory creams
Hair removal in different environments (home, ward, anesthetic room, operating room)
Hair removal conducted at different times pre-operatively

Characteristics of clinical studies included in the review (Appendix D2)
One systematic review was identified (Kjonniksen 2002). However, it was considered to be of poor
quality as it included observational studies and did not present quality assessments of the included
studies. Heterogeneity of study design was described, but data were not pooled so formal
assessments of heterogeneity were not presented.

In addition to the reviews identified in the original search the reference list of the systematic review
was searched for any studies not previously identified.

There were 11 potentially eligible studies identified, of which eight were included (Seropian 1971;
Balthazar 1981: Court-Brown 1981; Alexander 1983; Thur de Koos 1983; Hoe & Nambiar 1985;
Rojanapirom 1992; Horgan et al 1999). Reasons for exclusion are included in Appendix F2.

There were 3084 patients in total including adults and children. A range of types of surgery were
undertaken including: elective inguinal heniorography (Balthazar 1981), abdominal operations (Court-
Brown 1981), appendicitis (Rojanapirom 1992), and surgical incisions for tumours and vascular
anomalies (Horgan 1999). One studys procedures included thoracic, abdominal, vascular, urological,
head and neck operations (Thur de Koos 1983). The type of surgical procedure was not reported in
three of the studies (Seropian1971; Alexander 1982; Hoe and Nambiar 1985).
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One study was conducted in the UK (Court-Brown 1981), five in the US (Seropian 1971; Balthazar
1981; Alexander 1983;Thur de Koos 1983;Horgan 1999), one in Singapore (Hoe and Nambiar 1985)
and one in Thailand (Rojanapirom 1992).

The following comparisons were found:
shaving versus clipping of hair, either on the night before surgery or on the morning of surgery
(4 comparison groups in all) (Alexander 1986)
shaving versus clipping of hair immediately prior to surgery (Balthazar 1981)
wet shave versus depilatory cream versus no skin preparation (Court-Brown 1981)
shaving versus no shaving (Hoe and Nambiar 1985)
scalp shaving versus no shaving (Horgan 1999)
shaving versus no shaving, both groups having skin preparation with 4% chlorhexidine scrub
(Rojanapirom 1992)
shaving or depilatory cream (Surgex). (Seropian 1971)
either a wet shave 30 minutes before surgery in the operating room area, or depilatory cream
(Neet) the night before surgery in the ward room. (Thur de Koos 1983)

All of the studies reported wound infection, however, the definition and timings of assessment varied
between the studies.

Characteristics of studies included in the health economic review (Appendix
D2)
Five studies were included in the cost-effectiveness review (Alexander 1983; Court-Brown 1981;
DeGeest 1996; Hamilton 1977; Powis 1976). Of these studies, two were also included in the clinical
review (Alexander 1983; Court-Brown 1981). Three further studies were also included (DeGeest 1996;
Hamilton 1977; Powis 1976).

Using a series of case studies, De Geest (1996), in a descriptive pilot study undertaken in Belgium,
compared the cost-effectiveness of three pre-operative skin preparation protocols: razor, clipper and
depilatory cream, in conjunction with whole body disinfection with chlorhexidine in patients undergoing
coronary artery bypass graft (CABG) surgery.

Using what appeared to be a prospective cohort study undertaken in the USA, Hamilton (1977)
compared pre-operative hair removal with disposable razors, clipper and depilatory cream, as well as
no hair removal.

Methodological quality of included clinical studies (Appendix E2)
The results of the quality assessment for included studies are shown in Appendix E2.
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The method of randomisation was stated and adequate in one study (Balthazar 1981), unclear in one
study (Alexander 1983) and not stated in three studies(Court-Brown 1981; Hoe and Nambiar 1985;
Rojanapirom 1992). Two studies were quasi-randomised (Seropian 1971;Thur de Koos 1983).

One study had partially adequate allocation concealment (Alexander 1993). The remaining studies did
not indicate whether concealment was attempted.

Blinding of outcome assessors was not stated in any of the studies.

Loss to follow-up was reported in two studies (Court-Brown 1981; Alexander 1983). Court-Brown
(1981) reported 2.9% and Alexander (1983) reported 3.6% loss to follow-up.

Methodological quality of included health economic studies (Appendix E2)
It was difficult to assess from these studies which methods of hair removal (i.e. shaving, depilatory
cream or clipping) were most cost-effective. In addition nearly all of these studies were undertaken
more than 20 years ago. Three studies (Alexander 1983; Court-Brown 1981; Hamilton 1977) had very
limited cost analyses. Court-Brown (1981) and Hamilton (1977) did not include the staff costs
associated with hair removal, which are important as the time spent by the health care professional
removing hair from the patient will vary between the different pre-operative hair removal interventions.
Alexander (1983) only included the costs of treating SSI in the analysis, and did not include the costs
of pre-operative hair removal.

Results

Shaving versus no shaving

Primary outcome rate of SSI

Three studies compared shaving with no shaving (Court-Brown 1981; Rojanapirom 1992; Hoe and
Nambiar 1995). It was decided to exclude the Hoe and Nambiar (1995) study from the analysis as
there were a variety of other differences between the groups, including the timing of the shaving and
solutions used for skin preparation. Meta-analysis of the remaining studies showed a borderline
significant difference between the groups with a higher incidence of SSI associated with shaving (OR
2.17 (95% CI 0.99,4.78); p=0.05). (Figure 1).





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Figure 1 Shaving versus no shaving
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Cost-effectiveness
Two studies (Court-Brown 1981; Hamilton 1977) compared shaving with no pre-operative hair
removal. As these two studies only included the costs of pre-operative hair removal, they found that
shaving was more costly than no hair removal.

Timing of shaving

Primary outcome rate of SSI

A comparison between shaving the night before the operation and the morning of the operation
(Alexander 1981) showed too much uncertainty to decide if there was a difference in SSI rates
between the two group (OR: 0.87 (95% CI: 0.48,1.57). , (Figure 2).

Figure 2 Timing of shaving
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Shaving versus clipping

Primary outcome rate of SSI
Two studies comparing shaving and clipping (Balthazar 1981; Alexander 1983) showed clipping was
favoured over shaving on the morning of the operation (p=.006). There was insufficient information to
determine if there was a difference when shaving or clipping was carried out either immediately prior to
the surgery or the night before. (Figure 3).


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Figure 3 Shaving versus Clipping
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Timing of clipping

Primary outcome rate of SSI
One study (Alexander 1983) comparing different times of clipping indicated that clipping in the morning
was favoured over the night before surgery, and the difference between the groups was statistically
significant. (Figure 4).

Figure 4 Timing of Clipping
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Single use versus multiple use of clipper heads
There were no studies identified that compared single use versus multiple use of clipper heads. GDG
consensus was that single-use clipper heads should be used to prevent transfer of micro-organisms.

Shaving versus depilatory cream

Primary outcome rate of SSI

Three studies examined the use of depilatory cream and compared with shaving. The creams used in
the four studies were as follows: Veeto (Court-Brown 1981) Surgex (Seropian 1971) and Neet (Thur
de Koos 1983) and the timings of application varied extensively between and within the studies. None
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of the authors gave information on bactericidal properties. Overall, the studies showed that the cream
was associated with fewer infections than shaving (OR 1.77, 95% CI 1.01, 3.11). (Figure 5). However,
there was some heterogeneity (I
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=54%) and these results should be treated with caution. Two of these
studies (Seropian 1971; Thur de Koos 1983) were quasi randomised trials.

Figure 5 Shaving versus depilatory cream
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Cost-effectiveness
Four studies (Court-Brown 1981; DeGeest 1996; Hamilton 1977; Powis 1976) examined shaving with
depilatory cream.

Court-Brown (1981) found that the costs of consumables per 100 patients were approximately 14 for
shaving and 22 for the depilatory cream.

DeGeest (1996) found no statistically significant difference in depilation costs for the two groups, with
median costs per patient for the razor and cream depilation groups being $6.13, and $8.16,
respectively (p=0.10).

Hamilton (1977) found that use of the depilatory cream was more expensive than shaving ($56.70 vs.
$11.40 /m
2
/1000 patients/year, respectively). The authors reported that despite the depilatory cream
being the most expensive intervention, the additional costs could be offset by the time and labour
saved. However, the authors did not provide any estimates of these savings.

Powis (1976) found that the mean cost to prepare an area of 250cm
2
(average hernia repair) cost
0.25 when using the depilatory cream compared to 0.80 when shaving, after taking into account the
time of staff and the disposable equipment used.

Cream versus no treatment

Primary outcome rate of SSI
There was only one study (Court-Brown 1987) comparing cream with no treatment, and it had too
much uncertainty to determine if there is a difference between the groups. (Figure 6).

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Figure 6: Depilatory cream versus no treatment
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Cost-effectiveness
Two studies (Court-Brown 1981; Hamilton 1977) examined depilatory cream with no pre-operative hair
removal. As these two studies only included the costs of pre-operative hair removal, they found that
cream was more costly than no hair removal.

Secondary outcomes length of stay
No data was presented in any of these studies on length of stay related to the use of different hair
removal techniques.

Economic modelling

Cost effectiveness of pre-operative hair removal: Methods

The methods and data used for this evaluation are presented in Appendix 1 of this review.

Cost effectiveness of pre-operative hair removal: Results
Cost-effectiveness analysis (cost per SSI prevented)
As shown in Table 1, the most effective method of hair removal was using electric clippers as it was
the method with the lowest number of SSIs following surgery. However, this method of hair removal
was also found to be the most expensive method. When compared to no preparation hair removal
using razors was found to be dominated (i.e. it was both less effective, had a higher proportion of
SSIs, and more costly). Shaving cream was found to be dominated by a combination of hair removal
using no preparation and hair removal with electric clippers. As a result, it was extended dominated,
and electric clipper was compared directly with no preparation. When electric clipper was compared to
no preparation, the additional cost per SSI prevented was found to be 252 (Table 1).






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Table 1. Number of SSIs and costs of hair removal for 1,000 patients undergoing surgery








Hair removal
method
No.
SSI
Costs of hair
removal ()
ICER (cost per SSI
prevented)
No preparation 65 0
Razors 94 530 Dominated by no
preparation
Cream 57 2,250 Extended dominated
Electric clipper 55 2,516 252

Cost-utility analysis
Despite shaving with razors being one of the less costly options for hair removal, once the costs of
treating SSI were included in the analysis, this option became the most expensive. After including the
costs of treating SSIs in the analysis, the use of clippers for pre-operative hair removal was found to
be the cheapest option and was also found to generate the highest number of QALYs (Table 2). As a
result, when hair removal using electric clippers was compared to no preparation, shaving cream, or
shaving with razors, it was found to be dominant (i.e. it was both more effective and less costly).

Table 2. QALYs gained and total costs for 1,000 patients undergoing surgery

Hair removal
method
QALYs
gained
Costs of
hair
removal
()
Costs of
treating SSI
()
Total costs
()
ICER (cost per QALY
gained)
Electric clipper 618.79 2,516 190,610 193,126
Cream 618.60 2,250 198,311 200,561 Dominated by electric
clipper
No preparation 617.86 0 227,699 227,699 Dominated by electric
clipper
Razors 615.35 530 328,355 328,865 Dominated by electric
clipper
Sensitivity analysis
The results of the probabilistic sensitivity analysis showed that in the cost-effectiveness threshold
range of between 20,000 and 30,000 per QALY, the use of electric clipper for pre-operative hair
removal was the intervention most likely to be cost-effective. Furthermore, the results of the analysis
also showed that irrespective of the cost-effectiveness threshold the use of electric clippers was
always the option most likely to be cost-effective. Hair removal with shaving cream was the next option
most likely to be cost-effective. Hair removal using razors and no preparation were found to be the
interventions with the lowest probabilities of cost-effectiveness.
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Cost effectiveness of pre-operative hair removal: Discussion
Results of both the cost-effectiveness and cost-utility analysis showed that hair removal with electric
clippers was the most cost-effective method for pre-operative hair removal. Not only was it found to be
cost-effective, but it was shown to be both more effective (in terms of SSIs prevented and QALYs
gained) and less costly than its alternatives. These results were further strengthened in the sensitivity
analysis, which showed that hair removal with electric clippers was the hair removal option most likely
to be cost-effective, irrespective of the cost-effectiveness threshold (i.e. the amount the decision maker
is willing to pay per unit of effect, in this case an extra QALY).

The results of our model are in line with the results from other studies evaluating the costs of different
hair removal methods, which did not recommend the use of razors for pre-operative hair removal
(Alexander 1983; Court-Brown 1981; DeGeest 1996; Powis 1976; Hamilton 1977). As with other
studies we found that although the use of razors was one of the cheapest interventions in terms of
material costs (Alexander 1983; DeGeest 1996), once the costs of treating SSIs were included in the
analysis, this intervention generated higher costs than the other methods of hair removal, and was
also associated with the highest rates of SSIs.

However, our study had several limitations. Firstly, the price of the electric clipper and charger were
not identified in the NHS Purchasing and Supply Agency catalogue, and had to be derived from a the
catalogue of a healthcare provider, which might not be the actual price paid by the NHS as it is likely
that the NHS would pay substantially less. Secondly, we only included the costs of treating SSI in
hospital, and not in the community. As SSI may also be treated in the community, our costs of SSI
treatment are likely to be an underestimate. Lastly, the time horizon of the model was limited to just
one year, due to limited data on the quality of life of patients who acquired an SSI.


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Evidence statements and recommendations 1
2
Level of
Evidence
Evidence Statements
1+ There is fair evidence to suggest that a higher incidence of SSI is associated
with shaving in comparison to no shaving.
1- There is insufficient evidence to determine if there is a difference in SSI rates
between shaving in the morning compared to shaving the night before.
1+

1-

1-
There is fair evidence to suggest that clipping is favoured over shaving
on the morning of the operation.
There is insufficient evidence to determine if there is a difference in SSI rates
between clipping and shaving carried out immediately before surgery.
There is insufficient evidence to determine if there is a difference in SSI rates
between clipping and shaving carried out the night before
1+ There is fair evidence to suggest that there is a significant difference in SSI
rates in the timing of clipping. Clipping done in the morning showed a lower
incidence of SSI when compared with clipping the night before.
1- There is insufficient evidence to show if there is a difference between depilatory
cream in comparison with shaving
1- There is insufficient evidence to determine if there is a difference in SSI rates
between depilatory cream and no treatment.
4 The GDG consensus was that single-use clippers should be used to prevent
transfer of micro-organisms.

Health economics evidence statement
HE

HE
There is evidence from the literature that the use of razors to remove patients
hair prior to surgery is not cost-effective.
Evidence from a decision analytic model showed that the use of electric clippers
for pre-operative hair removal was cost-effective when compared to no hair
removal, shaving using razors and shaving cream. The use of electric clippers
was not only found to generate more QALYs but was also found to be less
expensive than these three interventions.
3
4
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Grade

Recommendations
A


GPP

On the day of surgery, preoperative hair removal, when clinically indicated,
should be undertaken using clippers.

Single-use clipper heads should be used.

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.
APPENDIX 1: Economic Modelling for Preoperative Hair Removal

The aim of this study was to determine the cost-effectiveness of different methods of pre-operative
removal of patients hair in the surgical field.

METHODS
We used a simple decision analytic model (Figure 1) to model the costs and outcomes of using
different methods of pre-operative hair removal, which included: no hair removal, hair removal using
razors, hair removal using shaving cream, and hair removal using electric clippers, in a hypothetical
cohort of 1,000 patients undergoing surgery. We modelled the probability of acquiring a surgical site
infection (SSI) after surgery, and the associated mortality risk for patients with or without SSI for each
group. As some patients have adverse reactions to shaving cream we incorporated this into the
decision model. We assumed that these patients would undergo hair removal with an electric clipper
instead.

The outcome measures derived from the model were: the number of SSIs prevented, and the number
of Quality-Adjusted Life-Years (QALYs) gained, which incorporates both quality of life and survival in a
single outcome measure. As quality of life information was only available for one year after surgery,
the time horizon of the model was one year after surgery.

The economic perspective adopted in the model was that of the UK National Health Service (NHS),
and all costs were updated to 2004 prices using the Hospital and Community Health Services (HCHS)
pay and price inflation index.
















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Figure 1. Decision analytic model
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Data
Effectiveness data
We used data from a systematic review of the literature undertaken for the clinical review to derive the
proportion of SSIs in each of the pre-operative hair removal groups.

The literature identified reported that in some cases shaving cream could cause adverse skin
reactions, and as such patients should be tested before full shaving by applying some cream on an
inconspicuous part of the skin. In those patients where an adverse reaction to the cream was
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identified, we assumed that hair removal using electric clippers would be used instead. From the
literature the rate of adverse skin reactions to shaving cream was found to be 7.8% (DeGeest 1996).

Mortality rates after surgery were derived from the Nosocomial Infection National Surveillance System
(NINNS) study (Coello 2005). In this study, between October 1997 and June 2001, a total of 140
English hospitals participated, with the study following a total of 67,410 surgical procedures in nine
defined categories of surgery. The study found, that in those patients who did not acquire an SSI
following their operation the risk of death was 2.6% (95% CI: 2.5 to 2.7%), compared to a significantly
higher rate of death to those patients acquiring an SSI, which faced a 6.6% (95% CI: 5.7 to 7.6%) risk
of dying following surgery (Table 1).

Table 1. Effectiveness data
Parameter Baseline Min./lower Max./upper References
SSIs
Rate of SSIs razor (%) 9.42 6.91 11.93
Alexander,1983
Relative risk electric clipper
vs. razor
0.58 0.36 0.92
Alexander,
1983
Relative risk cream vs. razor 0.61 0.36 1.02
Court-
Brown,1981
Relative risk no preparation
vs. razor
0.69 0.39 1.25
Seropian,1971;
ThurdeKoos,19
83
Mortality rate after surgery
Coello,2005
Patients with SSI (%) 6.64 5.72 7.56

Patients with no SSI (%) 2.56 2.44 2.68

Adverse skin reaction using
cream (%)
7.76 3.5 12.8

Utility values

Patients with SSI 0.57 0.51 0.64
Shmueli,1999
Patients with no SSI 0.64 0.57 0.71
Whitehouse,20
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Quality of life data in patients undergoing surgery were derived from a case-control study, which
compared the impact of SSIs following orthopaedic surgery on quality of life (Whitehouse 2002). In this
study, case-patients (i.e. those with an SSI) and matched controls were interviewed one year after
detection of SSI or after initial surgery, respectively. Quality of life was measured using the short form
of a questionnaire containing 36 items (SF-36). Results of the SF-36 were then converted to utility
values using the algorithm developed by Shmueli 1999. These utility values are reported in Table 1.

Resource use and cost data
The costs included in the analysis were the direct costs of the different hair removal methods (i.e. staff
time associated with removing patients hair and the hospital costs associated with treating a wound
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2
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12
infection). The costs of the actual surgical procedure were not included as we assumed they would be
similar between the four different patient groups.

The time required to remove patients hair prior to surgery was derived from DeGeest (1996) This
study found that the median time required for hair removal (after standardisation of hair growth
between groups), was: 8min 32sec for a shaving area of 1.78m
2
using razors; 16min 13 sec for a
shaving area of 1.83m
2
using clippers; and 6min 20sec for a shaving area of 1.80m
2
using shaving
cream. Using this data, we estimated the time required to remove hair in an area of 0.25m
2
, for each of
the three removal methods. The time taken was then multiplied by the average wage for a band E
nurse (Netten 2005 - Table 2).

Table 2. Resource use and costs
Parameter Baseline Min./lower Max./upper References
Depilation time (seconds per
1.0m
2
)

Clipper 417 206 628 De
Geest,1996
Razor 319 110 527
Shaving cream 238 150 325
Average wage band E nurse (
per min.)
0.31 0.29 0.41
Cost of clipper
Annual cost () 55.75 30.50 96.03 NHS 2005
Price of disposable clipper
blade ()
1.92 1.73 2.11 Westons
Health
No. operations per year 1000 800 1200 Assumption
Cost of shaving cream
Price of 100ml of shaving
cream ()
4.69 3.75 5.63 Personal
communicati
on
Number of operations per
100ml
2 1 3 Personal
communicati
on
Price of disposable razor () 0.12 0.11 0.13 NHS 2005
Costs of treating SSI To update
Additional days in hospital if
SSI
11.37 9.43 13.66 Coello 2005
Cost per bed day due to SSI
()
306.58 229.94 383.23
13
14
15

The price of an electric clipper (94.91) and its charger (73.88) were derived from a healthcare
providers catalogue (Westons Health 2005), with the price of the disposable blades (1.92 per blade)
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used in the electric clipper being derived from the NHS Purchasing and Supply Agency catalogue
(NHS 2005 - Table 2). We assumed that one clipper could be used during a three-year period. Based
on a 3.5% interest rate, the yearly cost of the clipper and charger was 55.75, using the equivalent
annual cost method (Drummond 2005).
1
2
3
4
5
6
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33
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36

Assuming an average of 1000 operations per year (DeGeest
1996), the cost per patient for using the clipper was estimated at 1.98 per patient.

The price of a single disposable razor blade (0.12) was derived from the NHS Purchasing and Supply
Agency catalogue (NHS 2005 - Table 2).

Following the study by DeGeest (1996), we assumed that the shaving cream used for patients hair
removal would be Veet . Using price data from Veets preferred supplier in the UK, the price of a
100ml package was 4.69, it was assumed that100ml of cream was enough for 2 patients (personal
communication with Veets customer care).

The hospital costs associated with treating SSIs were derived from the NNINS (Coello 2005). The
survey found that patients who acquired an SSI had an additional length of stay in hospital of 11.4
days than patients with no SSI. The study also found that the extra day spent in hospital due to SSI, in
2004 prices, was 307. This translates to an additional 3,500 per patient for treating an SSI (Table 2).

Analysis
Results from the decision tree model predicted the number of SSIs prevented, the number of deaths
prevented and the number of QALYs gained with each hair removal strategy. Each of the hair removal
methods was then ranked by costs (i.e. from the least to the most costly) and an incremental cost-
effectiveness ratio (additional cost per SSI prevented), and an incremental cost-utility ratio (additional
cost per QALY gained) were then estimated by comparing each hair removal method with its next best
alternative.

Sensitivity Analysis
Uncertainty was investigated using probabilistic sensitivity analysis. Probability distributions were
specified around each parameter in the model (in this case gamma distributions for cost and resource
use parameters, log-normal for relative risks and, and beta distributions for all others). The model was
then run 1,000 times so that a different value for each parameter in the model was randomly drawn
each time. Using results from the sensitivity analyses we derived a cost-effectiveness acceptability
curve (CEAC) showing the hair removal that was more likely to be cost-effective at a given cost-
effectiveness threshold (i.e. the amount the decision maker would be willing to pay for an additional
QALY).
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6.3 Mechanical bowel preparation for elective colorectal surgery 1
2
3
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32
33
34
35

Introduction
This review is an update of a Cochrane review, (Guenaga K, Atallah AN, Castro AA, Matos DDM,
Wille-Jrgensen P), Mechanical bowel preparation for elective colorectal surgery. The Cochrane
Database of Systematic Reviews 2005, Issue 1).

Objective
The objective of this review is to determine the clinical and cost effectiveness of prophylactic,
preoperative bowel preparation for the prevention of postoperative surgical site infection (SSI).

Criteria for considering studies for this review
Types of intervention
Any strategy in mechanical bowel preparation for patients undergoing elective colorectal surgery
compared to no mechanical bowel preparation.
Data extraction specific to this review
In addition to SSI rate, the outcomes, anastomotic leakage, extra-abdominal complications and
peritonitis.
Characteristics of the included studies in the clinical effectiveness review
(Appendix D3)
Fourteen studies were identified by the Cochrane review of which nine were included (Brownson 1992;
Burke 1994; Santos 1994; Fillmann 1995; Miettinen 2000; Tabusso 2002; Bucher 2003; Fa-Si-Oen
2003; Zmora 2003). Reasons for exclusion are listed in Appendix D3. One of the included studies was
published in Portuguese (Fillmann 1995), and identified in the Lilacs database. One study was in
Spanish (Tabusso 2002). The others were published in English language. Three studies were
published as abstracts only (Brownson 1992, Bucher 2003, Fa-Si-Oen 2003). Data from the latter
study were retrieved from another publication (Slim 2004).

The update search identified three studies, one of which was included (Bucher 2005). This appeared
to be the final report of the trial described in the conference abstract, Bucher 2003. It was decided to
replace the 2003 abstract with the 2005 full paper. Reasons for exclusion are given in Appendix F3.

There were a total of 1695 patients in the in the nine studies. All studies included adults and one study
included children (Santos 1994).

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9
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30
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33
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36
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39
One study was conducted in the UK (Brownson 1992), 2 studies in Brazil (Santos 1994; Fillman 1995),
one study each in Finland (Miettinen 2000), Ireland (Burke 1994), Switzerland (Bucher 2005) and Peru
(Tabusso 2002). Location of studies was not provided for two studies (Fa-Si-Oen 2003; Zmora 2003).

All but one of the studies reported anastomotic leakage as the primary outcome and surgical site
infection as a secondary outcome. One study (Bucher 2005) reported both as primary outcomes. For
this guideline, the primary outcome is rate of SSI, but it is possible that the included studies may not
be adequately powered for wound infection outcomes, and there may be reporting bias. For this
review, as far as possible, SSIs were restricted to infections in the wound and in deeper layers
involved in the surgical procedure, as distinct from other complications such as anastomotic leakage,
abdominal abscess and peritonitis. This is not the definition in some of the studies or that used in the
Cochrane review, which include all infectious complications.

The duration of follow-up varied between studies. Three studies reported infections 30 days after
surgery (Bucher 2005; Fillmann 1995; Zmora 2003), one was 30 days or until hospital discharge
(Santos,1994), and one was 1-2 months after surgery (Miettinen 2000). Two studies appeared to have
a follow up of seven days (but not clearly reported) (Burke 1994; Tabusso,2002) and two studies did
not indicate the duration at all (Brownson 1992; Fa-Si-Oen 2003).

Characteristics of studies included in the Health Economic review
There was no economic evidence comparing bowel preparation before colorectal surgery with no
preparation of the bowel.

Methodological quality of the included studies (Appendix E3)
Three studies described an adequate method of randomisation (Bucher 2005; Fillmann 1995; Zmora
2003), and the remaining studies were unclear.

Allocation concealment was assessed to be adequate or partial in four studies (Santos 1994; Fillmann
1995;Miettinen 2000; Zmora 2003). In the others (Brownson 1992, Bucher 2005, Burke 1994, Tabusso
2002, Fa-Si-Oen 2003), the allocation concealment was unclear.

With the exception of two (Brownson 1992, Tabusso 2002), all of the studies described the two
allocation groups as being equal according to gender, age, types of operation, and diagnosis. Tabusso
2002 indicated a difference between the allocation groups in age, haemoglobin level and serum
albumin.

Only one study stated that the outcome assessors were blinded (Bucher 2005) and only two studies
(Bucher 2005; Fillmann 1995) reported an a-priori power calculation.

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Three studies did not report if there was loss to follow up (Brownson 1992; Fa-Si-Oen 2003; Tabusso,
2002
1
2
3
4
5
6
7
8
9
10
11
12
13
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16
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18
19
). Burke 1994 reported 9.1% withdrawal; Santos 1994 reported 5% withdrawal, and Zmora 2003,
8.6%. Two studies (Fillmann 1995, Miettinen 2000) reported that all patients completed the study.

The Cochrane review indicated that all of the studies reported wound infection. However, in some
studies, the definition of wound infection and the timings of the assessment were not clearly indicated.

Results

Primary outcome rate of SSI
All the studies were included in the analysis, even though in one case the duration was reported to be
1 to 2 months after surgery (Miettinen,2000), and two studies were only reported as conference
abstracts (Brownson 1992, Fa-Si-Oen 2003). Meta-analysis of the nine studies found a statistically
significant difference in the rate of SSI, favouring no bowel preparation; Peto OR 1.53 (95% CI: 1.03,
2.26); p=0.03 (Figure 1). This is a number needed to harm of 33. There appeared to be no
heterogeneity between studies (I
2
=0%). A sensitivity analysis in the absence of the two abstracts
showed a slightly bigger effect compared with the full result.

Figure 1: Rate of SSI
20
21
22
23
24
25
26
27
28
29
30
31

Secondary outcomes

Anastomotic leakage
This was the primary outcome of most studies. Meta-analysis of the nine studies found a statistically
significant increase in anastomotic leakage when the patients were given bowel preparation. The
Cochrane plot is reproduced in figure 2; Peto OR 2.07 (95%CI 1.29, 3.31); this is a number needed to
harm of 33.



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1 Figure 2: Anastomotic leakage
2
3
4
5
6
7

Peritonitis
A meta-analysis of five studies showed a statistically significant difference favouring no preparation,
but with a wide confidence interval. Peto OR 2.39, 95% CI: 1.06, 5.41) (p=0.04). [Figure 3]
Figure 3: Peritonitis


Infectious extra-abdominal complication
8
9
10
11
12
13
14
15
Patients in three studies (Bucher 2005, Fillmann 1995, Miettinen 2000) developed infectious extra-
abdominal complications. A meta-analysis showed a wide confidence interval and there was too much
uncertainty to draw conclusions. [Figure 4]

Figure 4: infectious extra-abdominal complications
16
17
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Cost-effectiveness
There is no economic evidence comparing bowel preparation before colorectal surgery with no
preparation of the bowel. However, the clinical review presented above found that bowel preparation
was not an effective intervention in preventing surgical site infection. Given that preparing the bowel
involves a number of health care resources, it is likely that preoperative bowel preparation is not a
cost-effective intervention to prevent surgical site infection.

Evidence statements and recommendations

Level of
evidence
Evidence statement
1+




1++

1+



1-


HE


There is good evidence from a meta-analysis of nine studies (reporting SSI as a
secondary outcome) to show a statistically significant increase in the rate of SSI
for patients receiving bowel preparation compared to no bowel preparation in
colorectal surgery.
There is good evidence from a systematic review that bowel preparation
statistically significantly increases the incidence of anastomotic leakage.
There is fair evidence showing a statistically significant increase in the rate of
peritonitis, for bowel preparation compared to no preparation in colorectal
surgery.
There is insufficient evidence in a meta-analysis of two studies to determine if
there is a difference in infectious extra-abdominal complications for bowel
preparation compared to no preparation.
There is no economic evidence comparing bowel preparation before colorectal
surgery with no preparation of the bowel. However, the clinical review
presented above found that bowel preparation was not an effective intervention
in preventing surgical site infection. Given that pre-operative bowel preparation
involves a number of health care resources, it is likely that bowel preparation
before colorectal surgery is not a cost-effective intervention to prevent surgical
site infection.
10

Grade

Recommendation
A

The use of pre-operative bowel preparation for elective colonic surgery is not
recommended.
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6.4 Hand hygiene 1
2
3
4
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6.4 (a) Hand decontamination

Introduction

The hand hygiene section is divided into general hand decontamination, which is covered by the NICE
guideline (No. 2 Prevention of healthcare-associated infections in primary and community care) and
the effects of removing nail polish, nail extensions and finger rings. Both parts refer to preoperative
preparation, and the hand decontamination section also applies to any contact with the patients until
discharge. This should be distinguished from section 6.6, which covers surgical scrubbing immediately
before entering the operating suite.

Methods of the review
As part of the search for hand hygiene reviews and surgical scrubbing, papers were examined for
evidence on the effects of hand decontamination on SSI rates. However, no trials were found, and it
was decided to cross refer to the recommendations of the NICE Infection control guideline.

Results
The NICE guidance is based on randomised trials measuring the effects of interventions on colony
forming units (CFUs). There is no direct association between CFUs and surgical site infections, and
there were no trials found that assessed the effect of hand decontamination practices on SSI rates.
However, the GDG concluded that relevant recommendations should be included to ensure good
practice, and to form a good basis for the rest of the SSI guideline.

Evidence statement and recommendations

Level of
evidence
Evidence Statement
4 GDG consensus was that recommendations from the NICE guideline on infection
control should be followed by health care professionals to ensure good practice,
and to form a good basis to aid the prevention of surgical site infections.
28
29
30
31
32

Recommendations
GDG consensus is that hand hygiene procedures should be followed as reported in NICE guideline
(SP1-SP7).

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1

Grade

Recommendations
B Hands must be decontaminated immediately before each and every episode
of direct patient contact or care and after any activity or contact that could
potentially result in hands becoming contaminated.

A Hands that are visibly soiled, or potentially grossly contaminated with dirt or
organic material, must be washed with liquid soap and water.

A Hands must be decontaminated, preferably with an alcohol-based hand rub
unless hands are visibly soiled, between caring for different patients or
between different care activities for the same patient.

D Before regular decontamination begins, all wrist and ideally hand jewellery
should be removed. Cuts and abrasions must be covered with waterproof
dressings. Fingernails should be kept short, clean and free from nail polish.

D An effective hand washing technique involves three stages: preparation,
washing and rinsing, and drying. Preparation requires wetting hands under
tepid running water before applying liquid soap or an antimicrobial
preparation. The hand wash solution must come into contact with all of the
surfaces of the hand. The hands must be rubbed together vigorously for a
minimum of 10-15 seconds, paying particular attention to the tips of the
fingers, the thumbs and the areas between the fingers. Hands should be
rinsed thoroughly before drying with good quality paper towels.

D When decontaminating hands using an alcohol handrub, hands should be free
form dirt and organic material. The handrub solution must come into contact
with all surfaces of the hand. The hands must be rubbed together vigorously,
paying particular attention to the tips of the fingers, the thumbs and the areas
between the fingers, until the solution has evaporated and the hands are dry.

D An emollient hand cream should be applied regularly to protect skin from the
drying effects of regular hand decontamination. If a particular soap,
antimicrobial hand wash or alcohol product causes skin irritation an
occupational health team should be consulted.

2
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6.4 (b) Removal of Nail Polish and Finger rings 1
2
3
4
5
6
7
8
9
10
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12
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34
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36
37

Objective

To evaluate the effects and costs of the removal of nail polish and finger rings, by the surgical team,
prior to surgical scrubbing, on postoperative surgical site infection (SSI) rates.
This review was is an update of an existing Cochrane systematic review, Removal of nail polish and
finger rings to prevent surgical infection (Arrowsmith 2001).

Criteria for considering studies specific to this review

Types of participants
Those members of the theatre team who scrub for invasive operative procedures: surgeon,
anaesthetist, surgeons assistants, scrub nurse, operating department practitioners, scrubbed
observers in any country.

Types of comparison
Removal of nail polish/varnish versus wearing nail polish/varnish
Newly applied nail polish/varnish versus old nail polish/ varnish
Removal of finger rings versus wearing finger rings

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C4b

Data extraction specific to the review
Details of outcomes reported include bacterial load on finger nails pre and post scrub. There were no
studies reporting on wound infection.

Characteristics of included study in the clinical effectiveness review (Appendix
D4b)
The Cochrane review identified only one RCT comparing unpolished nails, freshly applied polish and
old/chipped nail polish (Wynd et al 1984). The primary outcome measure in this study was colony
forming units (CFUs). Wound infection rates were not reported as the study did not follow the nurses
up during surgical procedures. The update by the NCC did not identify any new studies. Reasons for
exclusion are listed in Appendix F4b.

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2
3
4
5
6
7
8
9
10
11
As there is no direct association between CFUs and surgical site infections, and there were no trials
found that assessed the effect of removal of nail polish and finger rings on SSI rates. The GDG
consensus was that fingernails should be kept clean and short. Nail polish, nail extensions, and hand
jewellery should be removed before hand decontamination.

Characteristics of studies included in the Health Economic review
No study was identified assessing the cost-effectiveness of the removal of nail polish and finger rings,
by the surgical team, prior to surgical scrubbing.

Evidence statements and recommendations

Level of
Evidence
Evidence Statements

4


GDG consensus was that nail polish can obscure hand washing and nail
extensions and rings should be removed prior to clinical interventions.

4 The GDG view is that although there is no evidence to suggest that the
wearing of nail polish, nail extensions and finger rings has an effect on
surgical site infection rates, it is likely that these practices increase bacterial
levels on the hands. The removal of nail polish, nail extensions and rings is
easily achieved and will not have major resource implications for the National
Health Service
12
13



Grade

Recommendation
GPP Fingernails should be kept clean and short. Nail polish, nail extensions and
hand jewellery should be removed before hand decontamination

14
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6.5 Non-sterile Theatre wear 1
2
3
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5
6
7
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30
Objective
To determine the clinical and cost effectiveness of disposable and reusable surgical attire (gowns,
headwear and footwear) in the prevention of post operative surgical site infection

Criteria for considering studies for this review
Types of interventions
Scrub suits versus or no scrub suits
Disposable versus reusable scrubs

Search Strategy
Details of the general approach to searching are reported in section 5.3. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C5.

Characteristics of included study in the clinical effectiveness review (Appendix
D5)
There were no clinical effectiveness studies identified that compared use of scrub suits and no scrub
suits or the use of disposable versus reusable scrub suits.

Characteristics of included study in the cost effectiveness review (Appendix
D5)
One study (DiGiacomo 1992) was identified in health economics review comparing the use of
disposable versus reusable scrubs by healthcare personnel.

DiGiacomo (1992) provided detailed cost analysis and reported costs by resource category, making it
easy to see which components was most resource intensive. This study included costs such as:
purchase of gowns, sterilisation, packaging, storage, removal and laundry costs. (Table 1)

Table 1. Annual costs of disposable and reusable gowns and scrub suits (costs $)

Hospital A
(Disposable)
Hospital B
(Reusable)
Operating gowns
Annual purchases
Laundry & treatment
Sterilisation
Wrapper purchases
62,950
62,950
0
0
0
24,784
4,392
14,560
4,732
1,100
Scrub suits 85,151 10,896
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Annual purchases
Laundry processing
85,151
0
8,093
2,803
Disposal costs 7,561 0
Total costs 155,664 35,680
Number of operations 5,927 9,657
1
2
3
4
5
6
7
8
9
10
11
12

Although the hospital using reusables undertook more operations than the hospital using disposables,
the authors found that the costs of scrub suits were lower in the hospital using reusable clothing.
These same conclusions apply even when operating gowns are not included in the analysis.

The GDG consensus was that surgical scrub suits should be worn by any person present in the
operative environment during all surgical procedures. Any person who is to be present during a sterile
surgical procedure within an operating theatre should change from civilian clothes and shoes into
designated theatre wear (including headwear) before entering that area.

Evidence statements and recommendations

Level of
Evidence
Evidence Statements
4 Surgical scrub suits should be worn by any person present in the operative
environment during all surgical procedures. Any person who is to be present
during a sterile surgical procedure within an operating theatre should change
from civilian clothes and shoes into designated theatre wear(including
headwear) before entering that area.

The use of disposable surgical scrubs compared with reusable surgical scrubs
appears to be associated with an increase in overall costs.

13
14



Grade

Recommendations
D Any person who is to be present during a sterile surgical procedure within an
operating theatre should change from civilian clothes and shoes into
designated theatre wear (including headwear) before entering that area

D Considerations should be given to using reusable surgical scrubs in
preference to disposable scrubs.

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6.6 Surgical Scrubbing 1
2
3
4
5
6
7
8
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34
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38
Objective
The objective of this review was to examine the effects and costs of different surgical scrub (duration
of scrub, use of nail pick or brush, different antiseptic solutions, scrub versus hand rub with alcohol
solution) on the postoperative surgical site infection rate.

Criteria for considerations for this review
The following comparisons were considered
Surgical scrubbing versus no surgical scrubbing (no surgical scrubbing can include a simple hand
wash, spray with an alcoholic solution or donning gloves with no preparatory cleansing)
Surgical scrubs performed for different lengths of time
Surgical scrubs performed using brushes against no brushes
Surgical scrubs performed using brushes against brushes impregnated with antiseptic solution
Surgical scrubs performed using different antiseptic solutions

Search Strategy
Details of the general approach to searching are reported in section 5.2. The search used for this
review is given in Appendix C6.

Characteristics of included study included in the clinical review
There was only trial suitable for inclusion. A table of excluded studies with reason for exclusion is in
Appendix F6.

Parienti (2002) included 4387 consecutive patients undergoing clean or clean-contaminated surgery at
6 surgical services from teaching and non-teaching hospitals in France.

Characteristics of included studies in the cost effectiveness review (Appendix
D6)
Four studies were included in the cost-effectiveness review (Cimiotti 2004, Larson 2001, Onesko
1987, Parienti 2002). Of these studies, one was also included in the clinical review (Parienti 2002).
Three further studies were also included (Cimiotti 2004, Larson 2001, Onesko 1984), all of which were
undertaken in the USA.

Cimiotti (2004) and Larson (2001) compared a waterless alcoholic solution for hand hygiene with a
traditional hand scrubbing with an antiseptic (either chlorhexidine gluconate (CHG) or povidone-iodine)
solution. The study by Cimiotti et al. (2004) was based on a cross-over trial study design. The study by
Larson et al. (2001) was also undertaken in patients undergoing surgery at an academic health centre.
The study was based on a cross-over-trial with a randomised external group.
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2
3
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6
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9
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27
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31
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39
40

The study by Onesko et al. (1987) was undertaken in patients admitted into an acute care community
hospital. The study was based on a before and after study design comparing a low-iodine hand wash
with non-medicated liquid natural hand soap for hand washing. The study evaluated wound infection
rates for all hospital acquired infections, but stratified their results by wound infection (i.e. it included
surgical site infections separately).

Methodological characteristics of included study in the clinical effectiveness review
The quality assessments for the included studies are shown in Appendix E6.

Six surgical services were randomised and the first protocol for each service was chosen randomly
using a random number table. Within each service the products were alternately assigned for the next
15 months. This is equivalent to randomising two orders ABABAB. and BABABAthis could be
classified as inadequate allocation concealment but is debatable.

Blinding of the outcome assessor was not met as surgical site infection was diagnosed by the
physician or surgeon looking after patient

Overall, the groups of patients treated using the hand-rubbing or the hand-scrubbing protocols were
comparable in terms of age, physical status, duration of surgery, whether the procedure was an
emergency or an elective one, and the type of surgery (gynaecology, urology, abdominal, orthopaedic
or ENT).

The study was powered to detect a difference of 2% in the surgical site infection rates between the two
protocols, and the two protocols were considered equivalent if the difference between the rates of
infections was less than 2%.

Loss to follow-up was reported as 1%.

Surgical site infection was defined in accordance with the CDC definition and timing of assessment
was after 30 days.

Methodological characteristics of included studies in the cost effectiveness
review (Appendix E6)
Three studies had important limitations (Cimiotti 2004, Larson 2001, Onesko 1987). In two studies
(Cimiotti 2004, Larson 2001) reported that there were deviations in protocol during the two time
periods under study. Furthermore, the study by Cimmiotti et al. 2004 was undertaken at a neonatal
intensive care unit. It is unclear from this study what types of patients were assessed. However, the
authors conclusions were drawn for a surgical population. The study by Onesko et al. 1987 was based
on a before and after study, this time with no cross over, therefore, other external factors could have
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confounded the results. Although Onesko (1987) stratified wound infection rates by wound category, it
did not do so for costs, therefore it was unclear how much of the total costs were due to surgical site
infection reduction.

The study by Parienti et al. (2002), reported the cost results of another French study (Girard 1996)
comparing the same solutions in similar settings. However, the cost results were not generated from
the same patient sample as that used in the effectiveness study.

Results
Clinical Effectiveness
One study was found that met the inclusion criteria for the review (Parienti 2002). It was a quasi-
randomised equivalence trial. The centres were randomised to 2 hand-cleansing methods alternately
every other month:
a hand-rubbing protocol with 75% aqueous alcoholic solution containing propanol-1,
propanol-2, and mecetronium etilsulfate, or
a hand-scrubbing protocol with antiseptic preparation containing 4% povidone iodine or
4% chlorhexidine gluconate.

The main analysis was on an intention-to treat basis. There were 53 infections among 2135 patients in
the hand-scrubbing group (2.48%) and 55 out of 2252 patients (2.44%) in the hand-rubbing group. The
odds ratio for the rate of SSI was thus 0.98 (95% CI 0.67,1.44) not significantly different. (Figure 1).

Figure 1: Hand rubbing versus hand scrubbing

Cost-effectiveness
Three studies compared hand hygiene with a traditional hand scrubbing with an antiseptic (either
chlorhexidine gluconate (CHG) or povidone-iodine) solution. On the cost side, all three studies found
that the waterless alcohol based solution was associated with significant cost savings. Although the
product costs of this solution were higher than for the traditional hand scrub, total savings were
generated due to savings in application time. Furthermore, further savings could potentially be
generated due to a decrease in waste disposal, water use and use of towels. Results of these studies
also showed that the use of a waterless alcohol-based rub was associated with better adherence to
the hand washing protocol than hand scrubbing with an antiseptic solution.
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One study compared a low-iodine hand wash with non-medicated liquid natural hand soap (Onesko
1987). The authors found that use of a low-iodine lotion soap was associated with a statistically
significant reduction in surgical wound infections when compared to non-medicated liquid hand soap.
The study also found that annual total savings due to nosocomial infection reduction due to soap
changeover were $109,500. However, these savings were not stratified by category of infection,
therefore it is unclear how much of the total savings are due to surgical site infection reduction.

The GDG consensus was that the surgeon, surgical assistant and scrub theatre practitioner should
use a scrub technique at the start of their involvement in the operative list. An alcoholic rub should be
used between operations and/or for dressing changes in a clean environment.

Evidence statements and recommendations
Level of
evidence
Clinical Effectiveness Evidence Statements
1+


There is fair evidence to suggest that there is no significant difference in SSI
rates between a standard hand rubbing protocol (75% aqueous alcoholic
solution) and a standard scrubbing protocol (4% povidone-iodine or 4%
chlorhexidine gluconate)

4 The GDG consensus was that the surgeon, surgical assistant and scrub theatre
practitioner should use a scrub technique at the start of their involvement in the
operative list. An alcoholic rub should be used between operations and/or for
dressing changes in a clean environment


Health Economics Evidence Statements










Results from three studies found that hand rubbing using a waterless alcoholic
solution generated cost savings due to reductions in staff time when compared
to surgical hand scrubbing. Results from these studies also found that
compliance with hand washing protocols was substantially higher when a
waterless alcoholic solution was used.

There is limited evidence that the use of a low-iodine lotion soap is cost-
effective when compared to a non-medicated liquid hand soap for hand
washing before surgery.

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Grade

Recommendation
D The surgeon, surgical assistant and scrub theatre practitioner should use a
scrub technique at the start of their involvement in the operative list. An
alcoholic rub should be used between operations and/or for dressing changes
in a clean environment.

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Objective
To determine the clinical and cost effectiveness of disposable and reusable sterile surgical attire
(gowns, headwear and footwear) in the prevention of post operative surgical site infection

Criteria for considering studies for this review
Types of interventions
Studies were considered in which surgical attire (gowns, headwear and footwear) was worn in
the immediate pre-operative period and throughout the operation, under sterile conditions and
prior to and during surgical incision. Body suits and helmets are also included.
Disposable and reusable attire of all types of materials are considered.

Search Strategy
Details of the general approach to searching are reported in section 5.3. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C7.

In addition to the standard health economics search we also performed a second review of the
literature of costing studies comparing the use of disposable and re-usable gowns following a request
from the Guideline Development Group (GDG). The terms used in this second search were gown*,
disposable*, reusable*, and cost*.

Characteristics of included study in the clinical effectiveness review (Appendix
D7)
Of the six potentially eligible studies one study (Aydeniz,1999) was included. The reasons for
exclusion are provided in Appendix F7.

Aydeniz (1999) included 200 patients undergoing gynaecological laparaoscopic operations in
Germany. This study compared maximum hygiene measures (complete sterile draping, thorough
disinfection of hands and sterile gown) with reduced standard of hygiene (limited to one drape,
reduced scrubbing of hands and no sterile gown); face masks and gloves were included in both
comparison groups.

The study indicated that incidence rates of secondary infection at 2-4 weeks post operative as
determined by local signs of infection (erythema, secondary healing, and abscess formation).

Characteristics of included studies in the Health Economics review (Appendix
D8)
A total of four studies (Mc Dowell 1993, Moylan 1987, Muller 1989, DiGiacomo 1992) were identified in
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health economics review comparing the use disposable and reusable surgical gowns used by
healthcare personnel, none of which were included in the clinical review.

Two studies (Moylan 1987, Muller 1989) assessed the cost-effectiveness of reusable and disposable
surgical gowns and drapes. Moylan 1987 compared the effects of a single gown and drape system of
either a spun laced fabric (disposable) or 280-thread-count cotton (reusable) utilised for alternate six-
week periods for 21 months. The authors evaluated a total of 2,181 clean and clean contaminated
procedures undertaken in a tertiary hospital or community hospital. Muller 1989, was in German, and
was therefore not included in the review. However, as the abstract of the study was also in English and
provided sufficient details, an overview of the study and its findings is reported here. This study
compared the use of disposable gown and drapes with the use of conventional reusable cotton gowns
and drapes in 1033 operations using a prospective cohort study.

Two further studies (DiGiacomo 1992, McDowell 1993) assessed the costs of reusable and disposable
surgical gowns. McDowell 1993 compared the economic implications of using three different gown
materials: FABRIC 450, a non-woven spunlaced fabric composed of 50% polyester and 50% percent
wood pulp (disposable); standard linen made from a 50/50 cotton/polyester fabric (reusable); and
ComPel a tightly woven 100% polyester fabric (reusable), in an average abdominal operation. Using
data from the literature, a survey of 30 American hospitals, and manufacturers reports, the author
estimated the costs of using each gown system for a typical abdominal operation. DiGiacomo et al.
(1992) compared the costs incurred by the operating rooms of two hospitals, one of which only used
disposable operating room apparel and another one that employed reusable scrub suits and gowns.

Methodological quality of included study in the clinical effectiveness review
(Appendix E7)
Aydeniz (1999) used the deterministic allocation of alternation. This is a non-randomised technique of
allocation. There is a possibility of bias due to the inability to protect the allocation by concealment.

Aydeniz (1999) provided details of sample size calculations. To detect a clinically important increase of
infections by 30% at least 1500 participants in each group would have been required therefore the
sample in this study of 200 was too small to measure any difference of effect between the treatment
and control groups.

The baseline characteristics do not differ significantly between groups. It was obviously not possible to
blind surgical staff to the treatment group or control group in any of the operations. In the reporting of
outcome information on the post operative (2-4 week interval) infection rates it was not clear who
conducted the interviews to establish whether there had been any infections. This could have resulted
in reporting bias

Body temperature and white blood cell count were measured 1-4 day post operative. At 2 weeks post
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operative an interview with the patient or referring gynaecologist was undertaken to obtain details of
febrile temperature, local signs of infection and any other complications. The local signs of infection
are defined as erythema, secondary healing or abscess formation.
Aydeniz (1999) followed up patients at 4 days post operative and 2-4 weeks. No losses to follow up
are reported. It is not made clear whether all patient data was obtained at the 2 week follow up.

Methodological quality of included study in the cost effectiveness review
Both of the two cost-effectiveness analyses (Moylan 1987, Muller 1989) compared using disposable
drapes and gowns against using re-usable drapes and gowns. Neither of these studies presented
separate results for drapes and gowns, making it difficult to separate the costs and effects of gowns
and drapes individually. For Moylan 1987, the results of the effectiveness study were based on a
retrospective cohort study, and the results of their effectiveness analysis have been put into question
(Rutala 2001). For the other study (Muller 1989) only the abstract of the study was available, therefore
it was difficult to judge the quality and validity of the results of the study.

Two studies (DiGiacomo 1992, Mc Dowell 1993) provided detailed cost analyses and reported costs
by resource category, making it easy to see which components were most resource intensive. These
studies included costs such as: purchase of gowns, sterilisation, packaging, storage, removal and
laundry costs.

Results
(a) Sterile gowns versus no gown
A reduced standard of hygiene was compared with a maximum standard of hygiene in a total sample
of 200. 3/100 developed an infection in the 2-4 week post operative interval in the group with reduced
hygiene standards compared with 5/100 in the group with maximum standards of hygiene. The result
was not significant, however, the confidence interval is too wide to draw any conclusions.

Figure 1: Reduced standard of hygiene versus maximum standard of hygiene
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(b) Reusable versus disposable gowns
There were no studies identified in the clinical effectiveness review which assessed the use of
reusable versus disposable gowns.


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Health economics
Cost-effectiveness of reusable and disposable surgical gown and drape system
Two studies assessed cost-effectiveness of reusable and disposable surgical gown and drape system
(Moylan 1987, Muller 1989). Both these studies found that the surgical site infection rate for the
reusable gown and drape system was significantly lower than for the disposable system. However, this
is inconsistent with clinical evidence from randomised trials presented above.

Moylan 1987 found that the costs including: gowns and drapes, laundry, handling and repair were
lower with the disposable drape and gown system than when using a reusable system.
Based on an analysis of costs over a 12-month period, Muller 1989 showed a reduction of 7.5% when
the disposable gown and drape system was used. No more information was available from the
abstract of this German study.

Costs of reusable and disposable surgical gowns
Two studies (DiGiacomo 1992, McDowell 1993) compared the costs of reusable and disposable
surgical drapes. In both cases, the two studies found that the use of disposable surgical gowns worn
by healthcare professionals were more expensive than the use of reusable gowns. As an illustration on
the types of costs included in these studies, results of DiGiacomo 1992 are shown here (Table 1).

Table 1. Annual costs of disposable and reusable gowns and scrub suits (costs $)

Hospital A
(Disposable)
Hospital B
(Reusable)
Operating gowns
Annual purchases
Laundry & treatment
Sterilisation
Wrapper purchases
62,950
62,950
0
0
0
24,784
4,392
14,560
4,732
1,100
Scrub suits
Annual purchases
Laundry processing
85,151
85,151
0
10,896
8,093
2,803
Disposal costs 7,561 0
Total costs 155,664 35,680
Number of operations 5,927 9,657
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Derived from DiGiacomo et al. (1992)

Although the hospital using reusables undertook more operations than the hospital using disposables,
the authors found that the costs of gowns were lower in the hospital using reusable clothing. These
same conclusions apply even when scrub suits are not included in the analysis.

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Results from McDowell (1993) showed that the gown cost per abdominal operation was higher when
disposable gowns were used than when reusable gowns were used. The average gown cost per
operation when using the disposable gown was $11.11 compared to $5.90-$7.09 when using the
reusable standard linen gown and $9.82 when using the disposable ComPel gown.

Results from the health economics review suggested that the use of disposable surgical gowns by
healthcare professionals was more costly than when using reusable gowns. However, there was also
evidence from two studies (Moylan 1987, Muller 1989) comparing the cost-effectiveness of reusable
and disposable gowns and drapes that when disposable gowns are used in conjunction with
disposable drapes, overall cost-savings were generated.

When deciding which gown system to implement, i.e. reusable or disposable, the healthcare facility
should be aware of all the cost implications associated with each draping system. These costs include:
laundry, handling, purchasing, sterilisation, and repair costs.

Different operations require different levels of surgical attire, from minimally invasive surgical
techniques to surgeries that pose a higher risk of infection, for example orthopaedic and cardiac
surgery. The GDGs view was that consideration of appropriate surgical attire needs to include
whether it is likely that the bacteria/particles can penetrate the gown/suit being worn and therefore
infect the surgical wound of the patient. Additionally, the risk to staff of contamination of infectious
agents during certain invasive surgical procedures that produce splashing of fluids and other matter
during the operations should be taken into consideration.

Evidence statements and recommendations

Level of
Evidence
Clinical Effectiveness Evidence Statements
1-


4
There is insufficient evidence to determine the effectiveness of sterile gowns
compared to no gowns in preventing surgical site infection

The decision to use full, minimal or no surgical attire to protect patients from
surgical site infection should be made after appropriate risk assessment has
been performed, taking into account clinical judgement appropriate to the
surgical procedure.

Health Economics Evidence Statement
The use of disposable surgical gowns over reusable gowns appears to be
associated with an increase in overall costs. However, results from two studies
would also suggest that when disposable gowns are used in conjunction with
disposable drapes, overall cost-savings are generated.
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Grade

Recommendations
4


The decision to use full, minimal or no sterile surgical attire to protect patients
from SSI should be made after risk assessment, taking into account the nature
of the surgical procedure

4 Consideration should be given to using disposable gowns in conjunction with
disposable drapes

3
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Introduction
This review is an update of a Cochrane review Double gloving to reduce surgical cross-infection
(Tanner and Parkinson, 2002). However, since no studies were identified in the update searches, this
review is a representation of the Cochrane review.

Objective
To evaluate the effects and costs of double gloving on postoperative surgical site infection (SSI) rates.

Criteria for considering studies for this review
In these studies the intervention relates to what is done by the surgical team, but the outcome of SSI is
in the patient. In the perforation outcome the surgical teams gloves are examined.

Types of interventions
Surgeons or scrub nurses using different types of gloves

Types of comparison
A comparison of two or more of the following:
Single gloves
Double gloves
Glove liners
Coloured puncture indicator systems
Cloth outer gloves
Steel outer gloves

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C8.

Characteristics of included studies in the clinical effectiveness review
(Appendix D8)
The Cochrane review identified 18 randomised studies that met the inclusion criteria (Tanner 2002).
The NCC-NSC update search did not identify any additional studies that met the inclusion criteria. Of
the included studies, only 2 assessed post-operative surgical site infection (Sanders 1990; Sebold
1993).

In both studies, the interventions concerned gloves worn by surgeons only, and the patients underwent
orthopaedic surgery (Sanders 1990; Sebold 1993).
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The studies examined the following comparisons:
Double latex versus latex inner with cloth outer glove (Sanders 1990)
Double latex versus latex inner with orthopaedic outer (Sebold 1993)
Double latex versus double latex with liner insert (Sebold 1993)

Although two studies (Sanders 1980; Sebold 1993) reported the rate of SSI, insufficient information
was provided on the method of measuring this outcome.

The Cochrane review also reported the outcome measure of number of perforations in the gloves. The
GDG did not consider this outcome to be a surrogate outcome, because correlation studies do not
appear to have been carried out. However, they interpreted the outcome of number of glove
perforations as an indication of increased risk of SSI. Therefore the findings of the Cochrane review on
perforations are also considered in the results section, and are used to inform consensus discussions.

Characteristics of studies included in the Health Economic review
No relevant economic evaluations comparing double versus single gloving were identified in the
review.

As no relevant economic evaluations were found, it is not possible to determine from the literature
review if the use of double gloving as an intervention to prevent surgical site infections is cost-effective
when compared to single gloving. Therefore, we decided to perform additional economic work in order
to inform GDG on the cost-effectiveness of double gloving practices as an intervention to prevent
SSIs.

Methodological quality of included studies in the clinical effectiveness review
(Appendix E8)
The results of the quality assessment taken from the Cochrane review for the two included studies are
shown in Appendix E8.

The method of randomisation was not stated for either of the studies. Allocation concealment was
reported for both studies and the method was partially adequate (sealed envelopes).
Blinding for glove perforation was reported for both studies, however, no details were provided for the
SSI outcome.

Results

Primary outcome rate of SSI
The Cochrane review reported that there were no infections in either of the studies, so conclusions
could not be drawn about the relative effectiveness of double gloving for preventing SSI.
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Secondary outcome number of glove perforations
Eighteen studies reported data on glove perforation rates. The studies varied in the types of gloves
compared, but all considered some form of double gloving for at least one of the interventions. This
meant that one pair of gloves were worn on top of another pair; sometimes an additional liner glove
was used. Outcomes measured were perforations in the innermost glove or in the outermost glove.

The main findings of the Cochrane review are:
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Single latex versus double latex
Perforations in outermost glove: eight studies found no statistically significant difference
between the single glove and the double glove; OR 0.90 (95%CI: 0.74, 1.08).
Perforations in innermost glove: eight studies found a large statistically significant difference
favouring the double glove; OR 3.72 (95%CI: 2.82, 4.91); p<0.00001.
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Single latex orthopaedic versus double latex
Perforations in outermost glove: one study found a large statistically significant difference
favouring the single orthopaedic glove; OR 0.16 (95%CI: 0.08, 0.30); p<0.00001.
Perforations in innermost glove: one study showed a wide confidence interval; OR 0.98
(95%CI: 0.43, 2.22).
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Double latex versus double latex indicator
Perforations in outermost glove: meta-analysis of two studies showed a wide confidence
interval; OR 1.28 (95%CI: 0.61, 2.69)
Perforations in innermost glove: meta-analysis of two studies showed a wide confidence
interval; OR 1.32 (95%CI: 0.64, 2.69).

Cost-effectiveness evidence

Cost effectiveness of double gloving: Methods

The methods and data used for this evaluation are presented in Appendix 1 of this review.

Cost effectiveness of double gloving: Results

As shown in table 1, the least effective gloving procedure, but also the cheapest was single gloving.
Compared to single gloving, single orthopaedic gloving prevented 54 additional glove perforations per
1,000 uses of gloves, at a cost of 0.40 per perforation prevented. Double gloving prevented an
additional 8 glove perforations when compared to single gloving, at a cost per perforation prevented of
80.62. Double indicator gloving prevented 4 additional glove perforations per 1,000 uses of gloves
compared with double gloving, at a cost of 183.50 per perforation prevented.


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Table 1. Outcomes and costs for 1,000 pairs of gloves

Gloving No.
perforations
Cost of
gloves
ICER (cost per
perforation
prevented)
Single 88 613.78
Single
orthopaedic
34 635.44 0.40
Double 26 1,227.57 80.62
Double indicator 22 1,980.78 183.50









Not all types of gloves can be used in all operations, and therefore we also present the results of the
analysis comparing single to double gloving. Compared to single gloving, double gloving would
prevent an additional 62 perforations, at a cost per perforation prevented of 9.91.

Sensitivity Analysis
Results of the sensitivity analyses are reported in Figure 2. Even at very low probabilities of a glove
perforation causing an SSI (<0.0009), the additional cost of single orthopaedic gloving compared to
single gloving were likely to be offset by savings in treatment of SSI. For probabilities of a perforation
causing an SSI between 4 and 9.3%, double gloving was the most cost-effective gloving option.
Finally, for double indicator gloving to be the most likely glove type to be cost-effective more than 9.3%
of perforations would have to lead to an SSI.
0
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Figure 2. Cost-effectiveness acceptability curve

When only single and double gloving were compared, the additional costs of double gloving were
offset by savings in treating SSI once the probability of a perforation leading to an SSI was over 0.5%
(95% uncertainty range: 0.2% to 1.0%).

Cost effectiveness of double gloving: discussion
For low-risk operations (i.e. those with a lower potential of causing a glove perforation), when the use
of all glove types was included in the analysis, the results showed that if the probability of a glove
perforation causing an SSI was below 4% single orthopaedic was most likely to be cost effective.
Above this threshold, double gloving was shown to be the option most likely to be cost-effective up to a
probability of 9.3% of perforations causing an SSI, above which double indicator become the option
most likely to be cost-effective. However, such a probability is unlikely to be realistic, given that no
study included in the Cochrane review found differences in SSI rates between different gloving
practices.

When only single and double gloving was compared the additional costs of double gloving would be
offset if more than 0.5% of perforations led to SSIs.

One limitation of our analysis is that it did not take into consideration the adverse effects on patients
quality of life due to a SSI, and quality of life aspects were not taken into account in our definition of
cost-effectiveness. For example, Whitehouse 2002 comparing quality of life between patients with a
SSI and those without, found that patients without an infection had higher scores for the physical
functioning (p=0.014) and role-physical domain (p=0.022) of the Medical Outcomes Study Short-Form
36 (SF-36). Omission of such quality of life considerations will therefore bias in favour of the single
gloving groups, which are potentially more prone to SSIs than double gloving practives, due to the
higher proportion of glove perforations.

Another limitation of this study is that as evidence on the effectiveness of single and double gloving
was derived from studies undertaken in low risk surgical specialities, i.e. those not including
orthopaedic surgery, the results from this model can therefore only be applied to these same surgical
specialities.

As this study only concentrated on the use of gloving to prevent SSI, other uses of gloving e.g. to
prevent cross-infection of other transmissible diseases such as HIV-AIDS, were not considered in the
model.

Further research on the effectiveness and cost-effectiveness of double gloving as opposed to single
gloving should, in the future, assess the link between a perforation and an SSI.

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GDG consensus
The GDGs consensus was that perforated gloves represent a potential risk either to the patient or
surgeon depending upon nature of the surgery and reservoir of infection. Therefore, double gloving
should be practised during procedures that are at high risk of perforation.

Evidence and Recommendations

Level of
evidence
Evidence Statement
1- There is insufficient evidence to determine the effectiveness of double gloving in
preventing SSI.

HE Evidence from a decision analytic model showed that for operations with a low risk of
glove puncture, single gloving represents the gloving practice most likely to be cost-
effective. However, at operations with a higher risk of glove puncture, double gloving is
most likely to be cost-effective.
The use of double indicator gloving would not appear to be cost-effective when
compared with double or single gloving.

4
The GDGs consensus view was that perforated gloves represent a potential risk either
to the patient or surgeon depending upon nature of the surgery and reservoir of
infection. Therefore, double gloving should be practised during procedures that are at
high risk of perforation.

9
10



Grade

Recommendation
D Double gloving should be practised during procedures that have a high risk of glove
perforation.

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APPENDIX 1: Economic modelling of gloving procedures to prevent SSI.

The aim of this study was to determine the cost-effectiveness of different gloving procedures to
prevent surgical site infections (SSIs).

METHODS
The initial objective was to model the cost per SSI using data from clinical studies on the number of
SSIs avoided using different gloving procedures. However, in a recent Cochrane review (Tanner 2002)
only two small studies were identified that used SSI as an outcome measure, both compared single
latex vs. double latex gloving. Neither study detected any SSIs for either single or double gloving.
Nonetheless, comparative clinical effectiveness data on the number of glove perforations avoided
were available for several gloving options and we used these to estimate the cost per glove perforation
avoided. We used a simple decision tree to model the costs and outcomes (glove perforations) of
using 1000 pairs of gloves (Fig. 1). The glove types evaluated were as follows:
1) single latex gloving;
2) single latex orthopaedic gloving;
3) double latex gloving; and
4) double latex puncture indicator gloving.
As not all glove types would be used for all operations we also compared single latex versus double
latex separately. In each arm of the tree, the surgical staff could either be allergic to latex or not, which
would change the glove use (i.e. synthetic if allergy to latex and latex if non-allergic). For each type of
gloving, there could then be one of two outcomes: a perforation, or no perforation. When using double
gloving, only perforations in the innermost gloves were counted as a perforation, which by default
would mean there was a perforation in the outermost glove.

However, results from the decision tree only give us the additional cost per perforation avoided. This
outcome measure is difficult to interpret and does not take into account any cost savings from
preventing SSIs. To estimate the cost per SSI averted it is necessary to know that a perforated glove
would lead to an SSI.

Unfortunately this data was not available. Instead we undertook a threshold analysis to determine the
probability that a perforation causes an SSI such that a particular gloving practice would cost the same
as its next best (and cheaper) alternative. This part of the analysis incorporated not only the number of
perforations and total costs of gloving per 1,000 pairs of gloves but also the costs of treating an SSI.
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Figure 1. Decision analytic model

Data
Effectiveness data
We used data from a meta-analysis (Tanner 2002) of 8 different studies to derive the proportion of
gloves perforated with single gloving compared to the proportion of innermost gloves perforated in the
double gloving (Table 1). Tanner 2002 also provided data from which the relative risk (RR) of single
orthopaedic and double indicator gloving compared with double latex gloving could be calculated. 95%
confidence intervals were then calculated around these proportions and RRs. However, Tanner 2002
only assessed low risk operations (i.e. those operations with a lower potential of causing a glove
perforation), therefore, our results will only be applicable to such types of operation.

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1 Table 1. Model parameters
Parameter Baseline Min./lower Max./upper References
Latex allergy 0.125 0.08 0.17
Arello 1992,
Hunt 1995,
Iacobelli 1992,
Lagier 1992,
Phillips 1997,
Yassin 1994
Rate of perforations Tanner,2002
Single 0.088 0.078 0.099
Double 0.026 0.020 0.032
Relative risks Tanner,2002
single orthopaedic vs. double 0.98 0.44 2.16
double indicator vs. double 0.82 0.42 1.59
Cost of latex gloves NHS 2005
single 0.54 0.27 0.97
single orthopaedic 0.56 0.45 0.68
double 1.08 0.54 1.94
double indicator 1.94 1.55 2.33
Cost of latex free gloves NHS 2005
Single 1.14 0.60 1.92
Double 2.27 1.21 3.83
Cost of SSI 1,937 1,169 2,727 Plowman
1999
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In the USA, occupational latex allergy was found to be between the 8% to 17% range (Arello 1992,
Hunt 1995, Iacobelli 1992, Lagier 1992, Phillips 1997, Yassin 1994). For the purposes of our study, at
baseline 12.5% of surgical staff were predicted to have a known latex allergy and therefore would wear
synthetic latex free gloves. We assumed that the numbers of perforations for synthetic gloves would
be the same as those estimated for latex gloves from Tanner 2002. As there were no orthopaedic or
double puncture indicator gloves free from latex, we assumed that when using single orthopaedic
gloves, those allergic to latex would use single latex gloving procedures, and when using the double
indicator gloves, those allergic would use double latex gloving procedures.

Cost data
Costs, in 2004 prices, of a box of surgical gloves to the NHS were derived from the NHS Purchasing
and Supply Agency catalogue (NHS 2005). We then estimated the unit cost of a pair of gloves by
dividing the cost per box of gloves by the number of glove pairs in each box. We assumed that the
cost of double gloving would be twice the cost of single gloving, i.e. the same type of glove would be
used twice.

The cost of an SSI was derived from Plowman 1999, which compared the mean hospital costs of
patients with a SSI to the mean hospital costs of patients with no infection (Table 1). Costs of treating
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an SSI were inflated to 2004 prices using the Hospital and Community Health Services (HCHS) pay
and price inflation index.

Analysis
Results from the decision tree model gave us the number of perforation and costs per 1,000 gloves
used for each of the four gloving practices evaluated. Each of the gloving practices was then ranked
by cost (i.e. from the cheaper to the most expensive) and an incremental cost-effectiveness ratio (or
cost per perforation avoided) was then estimated by comparing each type of glove with its next best
alternative.


Sensitivity Analysis
For the threshold analysis the probability (P) of a perforation causing an SSI such that a particular
gloving practice would cost the same as its next best (and cheaper) alternative was calculated as
follows:


P = C
n
C
c
(C
SSI
x N
c
) (C
SSI
x N
n
)

Were C
n
is the total cost of the more costly gloving procedure, C
c
is the total cost for the next best (and
cheaper) alternative gloving procedure, C
SSI
is the cost of an SSI, N
n
is the number of perforations in
the more costly gloving procedure, and N
c
is the number of perforations in the next best alternative
gloving procedure.

Uncertainty was investigated using probabilistic sensitivity analysis. Probability distributions were
specified around each parameter in the model (in this case gamma distributions for cost parameters,
log-normal for RRs, and beta distributions for all others). The model was then run 1,000 times so that a
different value for each parameter in the model was randomly drawn each time. Using results from the
sensitivity analyses we derived a cost-effectiveness acceptability curve (CEAC) showing the gloving
procedure that was more likely to be cost-effective at a given probability that a perforation would lead
to an SSI.
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Objective
This review was an update of an existing Cochrane review (Lipp and Edwards, 2004 ) which examined
effectiveness of disposable face masks for clean surgery only The review will examine whether the
use of disposable surgical face masks worn by the surgical team prevents post-operative surgical
wound infection for all types of surgical classification.

Criteria for considering studies for this review

Types of comparison
Disposable surgical face mask versus no mask in adults and children undergoing clean surgery.
Due to the difference in specifications the original authors definition of disposable surgical mask was
used.

Search Strategy
Details of the general approach to searching are reported in section 5.3. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C9.

The Cochrane systematic review (Lipp and Edwards, 2004) search was broad enough to capture clean
or dirty surgery. Therefore a further search for dirty surgery by the NCC-NSC was unnecessary and
the reviewer was contacted and a list of references from the original search was obtained for sifting.

The NCC-NSC reviewer checked the included trials (Tunevall 1991, Chamberlain 1984); the exclusion
list; and other references of ineligible trials provided by the authors of the systematic review (Lipp and
Edwards, 2004) for trials to be considered in this review.

Characteristics of study included in the clinical effectiveness review (Appendix
D9)
The Cochrane review identified thirteen potentially eligible studies of which two were included
(Chamberlain 1984; Tunevall1991).

There were a total of 3129 patients undergoing a range of types of surgery including breast, acute and
vascular surgery (Tunevall,1991) and major or minor abdominal and vaginal surgery
(Chamberlain,1984).
Both of the studies reported on wound infection as an outcome but there were different definitions of
infection and the timing of the assessment was indicated in only one study (Tunevall,1991). In
Chamberlain (1984) information on wound infections reported for vaginal surgery are not included in
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this review, as vaginal surgery does not fall under the remit of the guideline as it does not result in a
visible incision.

Characteristics of studies included in the cost effectiveness review (Appendix
D9)
No published economic evaluations were found comparing the use of surgical face masks with no use
in order to prevent SSIs.

Due to the lack of evidence on either the effectiveness or cost-effectiveness of surgical face masks we
undertook a costing exercise to determine the potential cost implications of face masks for the NHS.

Methodological quality of the included studies in the clinical effectiveness
review
The results of the quality assessment for included trials are provided in Appendix E9.

The method of randomisation was described in only one study (Chamberlain 1984) and not described
in Tunevall (1991). In both studies allocation concealment is unclear. Baseline comparability was
described in Tunevall (1991) for age and types of surgery.

The outcome measure used in Tunevall's (1991) trial was wound infection defined as pus, visible to
the naked eye, or cellulitis without pus, both requiring debridement or percutaneous drainage and/or
antibiotic therapy and was assessed at 2 months. With this study follow up was until after discharge,
but it was not explicit how these patients were followed up once discharged. There was a post
discharge reporting procedure, however no follow period is specified. Blinding of outcome assessors
was in place for Chamberlain's (1984) study, where members of laboratory staff were unaware of the
group allocation of the specimens obtained. In the study by Tunevall (1991), specific notification of the
trial was given with each wound swab submitted for culture, allowing the potential for detection bias.

Neither study was analysed on an intention to treat basis. Chamberlain's (1984) study was
discontinued after seven weeks after a third case of post-operative infection in the unmasked group
was diagnosed. However the authors acknowledge that although two of three wounds grew
staphylococcus aureus in neither case was it a strain which corresponded to those isolated from the
staff (collected via settle plates). Similarly in the study by Tunevall (1991) no drop outs were reported.

Chamberlain (1984) did not define wound infection, but two out of the three surgical site wound
infections reported were noted as serious enough to warrant antibiotics. The other infection caused by
vault haematoma after abdominal hysterectomy was identified by a high vaginal swab and treatment
prescribed. All patients in this study were examined daily until discharge.


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Results
Both of the included studies (Chamberlain 1984, Tunevall 1991) compared the use of disposable
surgical face masks with using no surgical face masks.

Chamberlain (1984) compared the wearing of face-masks to no masks in gynaecological surgery. The
study was underpowered to detect significant differences (Non Significant Difference (NSD): OR 0.07
[0.00-1.63]).

Tunevall (1991) included relevant data for all surgical wound classifications. The total number of
participants included was 3,088 of which 1429 were previously identified as clean surgery (Lipp and
Edwards, 2004). A further 1659 participants underwent contaminated and dirty surgery. The results
shows the effect of all surgery (clean and dirty) combined

Tunevall (1991) results for surgical site infections for all surgery were 73/1537 for the masked group
and 55/1551 for the no mask group (NSD, OR1.36 [0.95 to 1.94]). See Figure 1

Figure 1: Masks versus no masks
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The GDG expressed concern that not wearing masks will expose staff to risk of infection ( e.g. HIV,
Hepatitis etc. agents from the patients, from spraying of fluids during surgical procedures). Therefore,
masks serve another important function that is not examined in these studies.

Costs of surgical face masks: Methods
As there is no evidence to indicate whether wearing surgical face masks by the surgery team results in
any harm or benefit to the patient undergoing surgery, we undertook a small costing study to
determine the cost of using surgical face masks in a typical operation in the UK.

In order to determine the costs of using disposable surgical face masks, the following information was
derived from a range of sources.
Average number of surgical staff wearing a face mask per operation;
Number of face mask changes during operation; and
The unit cost to hospitals of a disposable surgical face mask.

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Expert opinion from members of the Guideline Development Group (GDG) was used to estimate the
number of surgical staff wearing a mask during a typical operation. This was estimated to be between
2 and 3 people in low risk surgery, and an average of 8 people (range: 6 to 10) in high risk operations.
Members of the GDG also reported that the surgical team did not generally change their face masks
during the operation, and as a result, it was assumed that each member of the surgical team wearing a
mask would not change it during the course of the operation. Costs of a standard disposable surgical
face mask (i.e. pleated filtration panel, nose conforming band, 4 ties) were derived from the NHS
Purchasing and Supply Agency catalogue (NHS 2005), which was found to range between 0.05 and
0.06.

Costs of surgical face masks: Results
Thus, for low risk surgical operations the total cost of a face masks was 0.14 per operation, and for
high risk surgical operations this cost was found to be 0.44 (range: 0.33 to 0.55) per operation.

As face masks may play an important role in protecting surgical staff from infectious agents (e.g. HIV
and hepatitis), there use could even be associated with cost savings due to reduced treatment costs of
infected staff.

Evidence statements and recommendations

Level of
Evidence
Clinical Effectiveness Evidence statement
1-

There is insufficient evidence to determine the effectiveness of face
masks to prevent surgical site infection

4

Face masks may play an important role in protecting staff from infectious
agents (e.g. HIV, hepatitis etc.). However, this was not examined in the
included studies.


Health Economics Evidence statement





The results of a simple costing exercise showed that the use of
disposable surgical face masks did not incur large additional costs for the
NHS (0.14 for low risk and 0.44 for high risk operations), and may even
generate cost savings due to staff protection from infectious agents.
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Grade

Recommendations
D The decision to use face masks to protect patients from SSI should be
made after appropriate risk assessment has been performed, taking into
account clinical judgement appropriate to the surgical procedure.

D Face masks can be used for the protection of staff from infection in
clinically appropriate surgical procedures (e.g. orthopaedic surgery).

3
4


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6.10 Preoperative skin antiseptics for preventing surgical wound
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Introduction
This review looks at the use of skin antiseptics for preventing surgical wound infection. It is an update
of an existing Cochrane review (Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for
preventing surgical wound infections after clean surgery. The Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD003949). This Cochrane review has been quality appraised by the
NCC-NSC reviewer using a quality appraisal checklist (NHMRC, 2001). All appraisal criteria were
fulfilled.

The NCC-NSC has conducted a further review of skin antiseptics for other surgical classifications
(clean-contaminated, contaminated and dirty surgery), and the two reviews are combined in this
section. It was decided to combine all forms of surgery because there is insufficient evidence to
suggest that clean and other types of surgery are different with respect to the effect of preventative
interventions. Separation of studies into clean/dirty subgroups will be considered in order to investigate
any significant heterogeneity between studies. This review presents both clinical and cost
effectiveness evidence.

Objective
To determine the clinical and cost-effectiveness of skin antiseptics for preventing surgical wound
infection.

Criteria for considering studies for this review
Types of intervention
There are three major types of antiseptics:
Iodine/Iodophors: their mode of action is by cell wall penetration, oxidation and substitution of
microbial contents with free iodine. Iodophors are solutions of iodine with a surfactant /
stabilising agent that liberates the free iodine. One commonly used iodophore is povidone
iodine (PI), a complex of iodine with poly(1-Vinyl-2-pyrrolidinone)
Alcohol, which denatures the cell wall proteins of bacteria. Concentration rather than type of
alcohol is more important in determining its effectiveness.
Chlorhexidine gluconate, which is thought to have a broad spectrum of activity

Types of comparison
Studies were considered in which antiseptics were applied to skin at the specific site of surgery, in the
immediate pre-operative period, under sterile conditions and prior to surgical incision.

The following comparisons were included:
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One or more antiseptics (solution / powder / drape) versus no antiseptic
One type of antiseptic versus another type of antiseptic
One antiseptic applied more than once versus the same antiseptic in a single application
One antiseptic applied more than once versus another antiseptic applied more than once

Search Strategy
Details of the general approach to searching are reported in section 5.3. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C10.

Data extraction specific to this review
Details of the type of antiseptic.

Characteristics of clinical studies included in the review (Appendix D10)
The Cochrane review identified 114 potentially eligible studies, of which five were included (Alexander
1985, Berry 1982, Lorenz 1988, Roberts 1995, Segal 2002). One manufacturer provided information
that led to the inclusion of one study (Roberts 1995). The review by the NCC identified four other
studies (Alexander 1985_2, Brown 1984, Ellenhorn 2005 and Kothius 1981). Reasons for exclusion of
studies are listed in Appendix F11.

2535 patients were included in the nine studies. One study was conducted in the UK (Berry 1982); the
rest were carried out in The Netherlands (Kothius 1981), and USA (Alexander 1985, Alexander
1985_2, Brown 1984, Ellenhorn 2005, Lorenz 1988, Roberts 1995, Segal 2002). All studies included
adults and Berry 1982 included some children. All studies were of a parallel group design.

A range of types of surgery were undertaken including: Caesarean section (Lorenz 1988); coronary
artery bypass graft (Roberts 1995; Segal 2002); elective laparotomy (Kothius 1981); abdominal
procedures (Berry 1982); nonlaparascopic abdominal operations (Ellenhorn 2005) and the rest did not
specify the operations. Three studies had surgery classified as clean only (Lorenz 1988, Roberts 1995,
Segal 2002); the rest had a mixture of clean and non-clean classifications (Alexander 1985, Alexander
1985_2, Berry 1982, Brown 1984, Kothuis 1981).

Three studies included in the review had three or more relevant comparison arms (Alexander 1985,
Alexander 1985_2, Segal 2002). The studies reported the effect of antiseptic solutions (scrub, wash,
spray, paint); we also distinguished a single application (e.g. alcohol based solution of iodine) from
multiple applications (e.g. scrub then paint). The following types of comparison were reported:

No studies compared an antiseptic to no antiseptic
Iodine 1 versus iodine 2: two trials, four comparisons (Alexander 1985_2 (three), Kothius
1981)
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Iodine in alcohol versus alcohol: two trials, four comparisons (Alexander 1985, Alexander
1985_2 (three comparisons))
Alcohol versus iodine: two studies (Alexander 1985, Lorenz 1988)
Iodine versus chlorhexidine: four studies, six comparisons (Alexander 1985, Alexander
1985_2 (three comparisons), Berry 1982, Brown 1984)
Alcohol versus chlorhexidine: one study (Alexander 1985_2)
Single application of iodine versus multiple application of iodine: two studies (Segal 2002;
Ellenhorn 2005)

Across the studies, different preparations of iodine were used, and the methods of application differed
too. Several of these comparisons change more than one variable at once, and, as such, are only
useful in drawing conclusions for comparison of the particular antiseptic regimens. This type of
comparison is indicated using the abbreviation [2V].

More specifically the comparisons were:

Iodine 1 versus iodine 2
Aqueous iodine versus alcohol based iodine
Povidone iodine paint versus 2% iodine / 70% alcohol tincture (Kothius 1981)
Alcohol based iodine 1 versus alcohol based iodine 2 (comparison of alcohol/water solutions)
2% iodine / 90% alcohol 1 min scrub versus 2% iodine / 50% alcohol 1 min scrub (both
arms had iodophor impregnated incise drape; Alexander 1985_2 )
2% iodine / 90% alcohol 1 min scrub versus 2% iodine / 70% alcohol 1 min scrub (both
arms had iodophor impregnated incise drape; Alexander 1985_2 )
2% iodine / 70% alcohol 1 min scrub versus 2% iodine / 50% alcohol 1 min scrub (both
arms had iodophor impregnated incise drape; Alexander 1985_2 )
Iodine in alcohol versus alcohol
2% iodine / 90% alcohol 1 min scrub versus 70% alcohol 1 min scrub
(both arms had iodophor impregnated incise drape; Alexander 1985; Alexander
1985_2)
2% iodine / 50% alcohol 1 min scrub versus 70% alcohol 1 min scrub
(both arms had iodophor impregnated incise drape; Alexander 1985_2 )
2% iodine / 70% alcohol 1 min scrub versus 70% alcohol 1 min scrub
(both arms had iodophor impregnated incise drape; Alexander 1985_2 )

Alcohol versus iodine
[2V] 70% alcohol 1 min scrub then iodophor impregnated incise drape versus
povidone iodine soap (10 min scrub) then two applications of PI paint then cloth drape
(Alexander 1985)
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versus iodophor scrub (5 min) then iodophor wash (Lorenz 1988)

These studies are confounded by the presence of an iodophor impregnated incise drape in the
alcohol arm only and so are not considered further.

Iodine versus chlorhexidine
Povidone iodine 10% in alcohol (two applications) versus chlorhexidine 0.5% in
alcohol (two applications, Hibitane) (Berry 1982)
[2V] Iodine soap scrub and aqueous povidone-iodine paint versus chlorhexidine spray
in alcohol (Brown 1984)
2% iodine / 90% alcohol 1 min scrub versus chlorhexidine in alcohol 1 min scrub (both
arms had iodophor impregnated incise drape; Alexander 1985; Alexander 1985_2)
2% iodine / 50% alcohol 1 min scrub versus chlorhexidine in alcohol 1 min scrub (both
arms had iodophor impregnated incise drape; Alexander 1985_2)
2% iodine / 70% alcohol 1 min scrub versus chlorhexidine in alcohol 1 min scrub (both
arms had iodophor impregnated incise drape; Alexander 1985_2)

Alcohol versus chlorhexidine
70% alcohol 1 min scrub versus chlorhexidine in alcohol 1 min scrub
(both arms had iodophor impregnated incise drape; Alexander 1985_2)

Single application versus multiple application
Aqueous iodine 1 versus aqueous iodine
[2V] Povidone iodine paint versus PI scrub (5 min) then paint (Segal 2002; Ellenhorn
2005)

All studies reported defined SSI as the primary outcome and in a way that corresponded with the CDC
definition. One study (Roberts 1995) specifically stated that the CDC definition was used to determine
whether a wound infection was present. Other, earlier studies published prior to the CDC guidelines
had included a majority of the indicators of an infected wound as defined by CDC. The follow up time
was not stated by Lorenz 1988 and Brown 1984 and was very short in Berry 1982. The GDG decided
to exclude Berry 1982 from the analysis for the SSI outcome.

Characteristics of studies included in the cost-effectiveness review (Appendix
D10)
In total five published studies were identified in the review (Armstrong 2001, Hagen 1995, Jacobson
2005, Lorenz 1998, Roberts 1995). However, after consideration from the members in the GDG three
studies were excluded from the review. The study by Armstrong et al. (2001) was rejected as it was
not undertaken in a patient sample, Jacobson 2005 and Roberts 1995 were excluded because one of
the interventions being compared is not currently in use in the UK. Hence, only two economic
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evaluations comparing different antiseptics were included in the review (Hagen 1995, Lorenz 1998).
One of these studies (Lorenz 1998) was also included in the clinical review. One further study was
included (Hagen 1995).

Using a retrospective cohort study (n=71) undertaken in the USA, Hagen 1995

examined the
effectiveness, savings in nursing time and product costs of two preoperative patient skin preparation
methods before CABG (i.e. isopropyl alcohol cleansing followed by the application of an iodophor-
impregnated drape, and idodophor scrub and paint preparation followed by the application of a plain
adhesive drape).

Methodological quality of included studies
The results of the quality assessment for included trials are shown in Appendix E10.
The method of randomisation was reported in seven studies, of which six were classified as adequate
(Alexander 1985, Alexander 1985_2, Berry 1982, Lorenz 1988; Roberts 1995, Segal 2002) and one
was classified as inadequate (Kothius 1981; allocation by odd/even year of birth). The other study did
not state the method of randomisation.

Berry 1982 randomised each operating list (cluster randomisation) and was the only study that did not
randomly allocate individual patients.

Allocation concealment was reported in two studies, of which a partially adequate method was
described in one (Brown 1984) and an inadequate method in the other (Kothius 1981). Kothius 1981
allocated the patients by odd/even year of birth.

One study (Segal 2002) described an a-priori power calculation. All the studies included in the review
but one (Alexander 1985_2) demonstrated baseline comparability of the groups. The Alexander
1985_2 study did not report patient characteristics.

There were no withdrawals in five studies (Berry 1982, Kothius 1981, Lorenz 1988, Roberts 1995,
Segal 2002), and there was less than 3% in two studies (Alexander 1985, Brown 1984) and the rest
did not say.

The risk of bias was assessed for each included study and two studies were assessed as being at
higher risk of bias (Berry 1982, Kothius 1981). The GDG excluded the Berry study from the analysis of
SSI rate because the follow up time was too short. The Kothius study was treated with caution.

Methodological quality of health economic evidence (Appendix E10)
Two studies (Lorenz 1988, Hagen 1995) in the review compared the use of isopropyl alcohol cleansing
followed by the application of an iodophor-impregnated drape, with idodophor scrub and paint
preparation followed by the application of a plain adhesive drape. In both these studies, the antiseptic
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comparison was confounded as different drapes were applied after skin preparation, making it more
difficult to determine which type of skin preparation antiseptic was more cost-effective by itself.

Results
For most comparisons the only outcomes reported were rate of SSI, and the results are reported for all
categories of surgical classification combined (although subgroup analyses were considered if there
was heterogeneity). .

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Iodine 1 versus iodine 2

Aqueous iodine versus alcohol based iodine effect of alcohol
Only one study (Kothius 1981) gave a direct comparison of aqueous iodine with alcohol based iodine,
even though the type of iodine differed in the two arms (Figure 1). This quasi-randomised study
showed little difference between aqueous povidone iodine and alcohol based (70%) free iodine (2%),
although the confidence interval is fairly wide.

Figure 1: aqueous iodine versus alcohol based iodine rate of infection
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Comparison of iodine in different alcohol/water solutions
Alexander 1985_2 compared a scrub for one minute using iodine in different alcohol/water solvents. In
each case, an iodophor polyester incise drape was also used. There was insufficient evidence to
distinguish between the solutions (Figure 2).









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Figure 2: Alcohol based iodine 1 vs alcohol based iodine 2 (comparisons of different
alcohol/water solvents)
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Single application of povidone iodine versus multiple application of povidone iodine

Two studies compared single and multiple applications of povidone iodine. Segal 2002 compared a
single application of PI paint versus a 5 minute scrub with PI followed by PI paint; both solutions were
aqueous. Ellenhorn 2005 compared a single application of PI paint versus a 5 minute scrub with PI
soap followed by aqueous PI paint, and was designed as an equivalence study. The meta-analysis
showed there was little difference between single and multiple applications, although the confidence
interval was fairly wide (OR 0.94, 95%CI 0.48, 1.85) (Figure 3).

Figure 3: Povidone iodine paint versus PI scrub (5 min) then PI paint


Cost-effectiveness
No study assessed the cost-effectiveness of a 5 minute scrub of PI followed by PI paint with a
single application of PI paint. However, a single application of PI paint was not found to be significantly
associated with an increase in SSI rates in the clinical review, and would generate cost savings due to
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less antiseptic being used and less staff time (i.e. 5 minutes) scrubbing the antiseptic. As a result, a 5
minute scrub of PI followed by PI paint would not appear to be cost-effective when compared to a
single application of PI paint.

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Iodine in alcohol versus alcohol
Three comparisons in Alexander 1985_2 and one in Alexander 1985 investigated the addition of iodine
to an alcohol based scrub solution, however, all arms of the comparisons were also given an iodophor
incise drape, so there is some confounding of the effect of iodine. The analysis (Figure 4) shows
insufficient evidence to decide if there is an effect of adding free iodine to an alcohol based scrub
solution in the presence of an iodophor incise drape.

Figure 4: Effect of adding free iodine to alcohol based scrub solution
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Alcohol versus iodine
Two studies compared iodine plus alcohol with iodine (Alexander 1985; Lorenz 1988).
However, in each case, the alcohol arm had an iodophor incise drape, but the iodine arm did not.
These studies were not analysed further because the change of more than one variable at once meant
the results were not informative.

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Iodine versus chlorhexidine
One study compared povidone iodine with chlorhexidine (Brown 1984). Brown (1984) used different
methods of application for the two arms (scrub then paint for PI and spray for chlorhexidine). Three
other comparisons within one study (Alexander 1985_2) examined the relative effects of iodine in
alcohol/water solutions and chlorohexidine. However, both arms also had an iodophor incise drape,
which may have masked the effects of the solutions. For convenience, the three iodine arms in this
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study were summed to give a single comparison with chlorhexidine. The separate analyses (Figure 5)
show little difference between solutions in the Brown 1984 study, and insufficient detail in the
Alexander (1985_2) study. In view of the different solvents involved in the Brown study and the
uncertainty in the Alexander study, the GDG did not draw conclusions on this comparison.

GDG consensus
The GDG consensus was that, in view of the lack of good quality evidence, and taking into account
tissue viability issues with povidone iodine and potential resistance to both antiseptics, their
recommendation was that either povidone iodine or chlorhexidine is acceptable as a skin cleansing
agent.

12 Figure 5; Iodine versus chlorhexidine
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Cost-effectiveness

From the clinical effectiveness review presented above, the use of chlorhexidine solution appeared to
be associated with significantly lower surgical site infections than when skin was prepared with
povidone iodine, with one study finding statistically significant reductions in SSI in favour of
chlorhexidine. However no economic evaluation was conducted to identify if the use of chlorhexidine
was cost-effective when compared to povidone-iodine. As a result, we conducted an economic
evaluation comparing skin preparation using chlorhexidine with povidone-iodine prior to surgery.

Cost effectiveness of iodine versus chlorhexidine: Methods
The methods and data used for this evaluation are presented in Appendix 1 of this review.

Cost effectiveness of iodine versus chlorhexidine: Results
Cost-effectiveness analysis (cost per SSI prevented)
As shown in Table 1, the most effective preoperative skin preparation solution was chlorhexidine as it
was the method with the lowest number of SSIs following surgery, and was also found to be less costly
than the use of povidone-iodine (2.20 vs. 2.30 per 1,000 patients, respectively).

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Table 1. Number of SSIs and product costs of skin preparation for 1,000 patients undergoing
surgery
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8

Hair removal
method
No. SSI Costs of
skin
preparation
()
ICER (cost per SSI
prevented)
Chlorhexidine 97 2.20
Povidone-iodine 148 2.30 Dominated by chlorhexidine

Cost-utility analysis
As shown in Table 2, once the costs of treating SSI were included in the analysis, the use of
chlorhexidine was found to generate substantial cost savings when compared to use of povidone-
iodine. The use of chlorhexidine for preoperative skin preparation was also found to be more effective
than povidone-iodine as it generated a higher number of QALYs (Table 2).

Table 2. QALYs gained and total costs for 1,000 patients undergoing surgery
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21

Hair removal
method
QALYs
gained
Total costs
()
ICER (cost per QALY gained)
Chlorhexidine 615.09 326,641
Povidone-iodine 610.69 496,701 Dominated by chlorhexidine

Sensitivity analysis
The results of the probabilistic sensitivity analysis showed that in the cost-effectiveness threshold
range of between 20,000 and 30,000 per QALY, the use of chlorhexidine for preoperative skin
preparation was more likely to be cost-effective than povidone-iodine. Furthermore, the results of the
analysis also showed that irrespective of the cost-effectiveness threshold the use of chlorhexidine was
always the option most likely to be cost-effective.

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Alcohol versus chlorhexidine

One study (Alexander 1985_2) compared a one minute scrub with 70% alcohol versus a one minute
scrub with chlorhexidine in alcohol (Hibitane). Both arms had an iodophore impregnated incise drape,
which may have masked the effects of the two solutions. The study had insufficient information to
determine if there is a difference between alcohol and chlorhexidine in alcohol (Figure 6).




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1 Figure 6: Alcohol versus chlorhexidine in alcohol
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Patient safety
The GDG considered a report from the national patient safety agency (NPSA) on the risks of patient
burns associated with the use of alcohol based skin antiseptics in operating theatres (Tomsett 2005).
The report states that it is quite normal for sparking to occur when electro-surgery (diathermy) is used,
and these sparks are able to ignite the vapour from alcohol based preoperative antiseptics. The
Medicines and Healthcare Products Regulatory Authority (MHRA) Safety Notice requires that if alcohol
based antiseptics are used in the presence of electro-surgery, surgeons must ensure that the
antiseptic is given adequate time to dry and that there is no pooling of the antiseptic (e.g. under the
drapes, in the folds of the patients skin). The Notice recommends surgeons should consider the use of
aqueous antiseptics where electro-surgery equipment is to be used, bearing in mind that these will
require longer drying times. The NPSA report also suggests the use of single use sachets (for both
aqueous and alcohol based antiseptics) this not only reduces the volume available, but also reduces
the risk of cross contamination from multi-use antiseptic bottles. Another suggestion was to use
smaller sponge applicators for skin preparation.

GDG consensus
In view of the uncertainties inherent in the evidence base, the GDG made a number of consensus
statements:
A) Use of alcohol based antiseptics
In view of recent safety NPSA concerns the GDG recommends aqueous products if at all
possible. However, if clinically appropriate alcohol products can be use sparingly. The volume
of antiseptic used should be minimised.
B) Iodine antiseptics in children
The GDG noted that practice is dictated by the contraindications of any antiseptic used. These
need to be considered when applying antiseptics to specific areas of the body such as the
mucous membranes and differing patient populations. The GDG also noted the adverse effect
of the suppression of the thyroid function when using iodine as a skin preparation solution in
neonates, and does not recommend the use of iodine based antiseptics in neonates and
infants.


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Evidence statements and recommendations 1
2
3
4
5
6
This review has proved complicated because there is a diverse range of studies, many of which were
of questionable quality and had comparisons that changed more than one variable at a time. There
was also variability in the outcome measures, for example, how infection was defined and when its
assessment took place. Despite these limitations, the following evidence statements were made:

Level of
evidence
Evidence statement
2+
There is fair evidence to show there is little difference in the rate of SSIs between
aqueous povidone iodine and alcohol based free iodine solutions.

1-
There was insufficient evidence in the rate of SSI in a single trial to distinguish
between a 1 minute scrub with iodine used in different alcohol/water solvents.

1+


HE
There is fair evidence to suggest there is little difference in the rate of SSI
between a single application of aqueous povidone iodine and a multiple
application (5 minute scrub of PI followed by PI paint).

The use of a 5 minute scrub of PI followed by PI paint would not appear to be
cost-effective when compared to a single application of aqueous povidone iodine.

1-

HE
There was insufficient evidence to determine if there was a difference in SSI rate
between povidone iodine and chlorhexidine.

Evidence from a decision analytic model showed that the use of chlorhexidine for
preoperative skin preparation of the surgical site was cost-effective when
compared to povidone-iodine. The use of chlorhexidine was not only found to
generate more Quality Adjusted Life-Years (QALYs) but was also found to be less
expensive than povidone-iodine. However, the model was based on infection
rates from the large study identified in the clinical review, which was limited due to
short follow-up and cluster randomisation.

4
The GDG consensus was that, in view of the lack of good quality evidence, and
taking into account tissue viability issues with povidone iodine and potential
resistance to both antiseptics, their recommendation was that either povidone
iodine or chlorhexidine is acceptable as a skin cleansing agent.

1-
There was insufficient evidence in four comparisons to decide if there is an effect
on the rate of SSI of adding free iodine to an alcohol based scrub solution in the
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presence of an iodophor incise drape.

1-
There was insufficient information in a single trial to determine if there is a
difference in rate of SSI between alcohol and chlorhexidine in alcohol in the
presence of an iodophor incise drape.

4
In view of recent safety concerns, GDG consensus was that aqueous products
should be used if at all possible. However, if clinically appropriate, alcohol
products can be used sparingly in line with the NPSA recommendations.

4
When choosing to use antiseptics on specific areas of the body (such as mucous
membranes), consideration should be given to known contraindications. Topical
iodine should not be used on neonates and infants.

1
2



Grade

Recommendations
D
When choosing to use antiseptics on specific areas of the body (such as mucous
membranes), consideration should be given to known contraindications. Topical
iodine should not be used on neonates and infants.

D
Aqueous povidone iodine and aqueous chlorhexidine are acceptable skin
cleansing agents. Alcohol based solutions should be used sparingly for safety
reasons.

D
Where clinically indicated, a single application of aqueous povidone iodine is
sufficient.

3
4


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APPENDIX 1: Economic modelling of preoperative skin antiseptics

The aim of this study was to compare the costs and outcomes of surgical skin preparation using
chlorhexidine with povidone-iodine prior to surgery.

METHODS
We used a simple decision analytic model (Figure 1) to model the costs and outcomes of two different
methods of preoperative skin preparation: chlorhexidine and povidone-iodine in a hypothetical cohort
of 1,000 patients undergoing surgery. We modelled the probability of acquiring a surgical site infection
(SSI) after surgery, and the associated mortality risk for patients with or without SSI for each group.

Figure 1. Decision Analytic Model
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The outcome measures derived from the model were: the number of SSIs prevented, and the number
of Quality-Adjusted Life-Years (QALYs) gained, which incorporates both quality of life and survival in a
single outcome measure. As quality of life information was only available for one year after surgery,
the time horizon of the model was one year after surgery.

The economic perspective adopted in the model was that of the UK National Health Service (NHS),
and all costs were updated to 2004 prices using the Hospital and Community Health Services (HCHS)
pay and price inflation index.




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Data
Effectiveness data
We used data from the clinical effectiveness review, which identified one study comparing skin
preparation with povidone-iodine or chlorhexidine (Berry 1982) to determine the proportion of patients
acquiring SSIs after skin preparation (Table 1).

Mortality rates after surgery were derived from the Nosocomial Infection National Surveillance System
(NINNS) study (Coello 2005). In this study, between October 1997 and June 2001, a total of 140
English hospitals participated, with the study following a total of 67,410 surgical procedures in nine
defined categories of surgery. The study found, that in those patients who did not acquire an SSI
following their operation the risk of death was 2.6% (95% CI: 2.5 to 2.7%), compared to a significantly
higher rate of death to those patients acquiring an SSI, which faced a 6.6% (95% CI: 5.7 to 7.6%) risk
of dying following surgery (Table 1).

Quality of life data in patients undergoing surgery were derived from a case-control study, which
compared the impact of SSIs following orthopaedic surgery on quality of life. In this study, case-
patients (i.e. those with an SSI) and matched controls were interviewed one year after detection of SSI
or after initial surgery, respectively (Whitehouse 2002). Quality of life was measured using the short
form of a questionnaire containing 36 items (SF-36). Results of the SF-36 were then converted to
utility values using the algorithm developed by Shmueli 1999. These utility values are reported in Table
1.

Table 1. Effectiveness, resource use and cost data
Parameter Baseline Min./lower Max./upper References
Rate of SSIs (%)
Chlorhexidine 14.77 11.35 18.19 To include
Povidone-iodine 9.71 6.97 12.44
Mortality rate after surgery (%)
Patients with SSI 6.64 5.72 7.56
Patients with no SSI 2.56 2.44 2.68
Utility values
Patients with SSI 0.57 0.51 0.64
Patients with no SSI 0.64 0.57 0.71
Costs of solutions ()
Chlorhexidine (600ml) 1.32 0.66 1.98
Povidone-Iodine (500ml) 1.15 0.58 1.73
Solution used per patient (ml) 110 100 120 Expert opinion
Costs of treating SSI
Additional days in hospital if SSI 11 9 14
Cost per bed day due to SSI () 307 230 383
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Resource use and cost data
The costs included in the analysis were the direct costs of the different hair removal methods (i.e.
product costs and hospital costs associated with treating a wound infection). The time costs
associated with preparation for the surgical site were not included as none of the studies reported the
preparation time required when using chlorhexidine or povidone-iodine, we therefore assumed they
would be similar between the two patient groups.

The prices of 500ml povidione iodine solution (1.15) and of 600ml chlorhexidine skin disinfection
solution (1.32) were derived from the NHS Purchasing and Supply Agency catalogue (NHS 2005).
Using expert opinion from members of the Guideline Development Group (GDG) it was assumed that
110ml (range: 100ml to 120ml) of solution would be used when preparing the surgical site of a patient
(Table 1).

The hospital costs associated with treating SSIs were derived from the NNINS (Coello 2005). The
survey found that patients who acquired an SSI had an additional length of stay in hospital of 11.4
days than patients with no SSI. The study also found that the cost of each extra day spent in hospital
SSI, in 2004 prices, was 307. This translates to an additional 3,500 per patient for treating an SSI
(Table 1).

Analysis
Results from the decision tree model predicted the number of SSIs prevented, and the number of
QALYs gained with each skin preparation method. Each of the skin preparation methods was then
ranked by costs (i.e. from the least to the most costly) and an incremental cost-effectiveness ratio
(additional cost per SSI prevented), and an incremental cost-utility ratio (additional cost per QALY
gained) were then estimated.

Sensitivity Analysis
Uncertainty was investigated using probabilistic sensitivity analysis. Probability distributions were
specified around each parameter in the model (in this case gamma distributions for cost and resource
use parameters, and beta distributions for all others). The model was then run 1,000 times so that a
different value for each parameter in the model was randomly drawn each time. Using results from the
sensitivity analyses we derived a cost-effectiveness acceptability curve (CEAC) showing the skin
preparation method that was more likely to be cost-effective at a given cost-effectiveness threshold
(i.e. the amount the decision maker would be willing to pay for an additional QALY).
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6.11 Drapes 1
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Objective

To determine the clinical and cost effectiveness of disposable and reusable drapes in the prevention of
post operative surgical site infection

Criteria for considering studies for this review

Types of comparison
Studies were considered in which drapes were applied to the patient in the immediate pre-operative
period, under sterile conditions and prior to surgical incision.

Types of drapes included linen (re-usable), paper or other material (disposable), adhesive incise
drapes and antiseptic impregnated drapes.

The specific comparisons to be made were:
Drape 1 versus drape 2
Disposable drapes versus reusable drapes

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C11.

In addition to the standard health economics search we also performed a second review of the
literature of costing studies comparing the use of disposable and re-usable draping practices following
a request from the Guideline Development Group (GDG). The terms used in this second search were
drape*, disposable*, reusable*, and cost*.

Data extracted specific to this review
The primary outcome was surgical site infection. Other outcomes which may influence choice of
draping method such as strength, ease of use, fluid repellency, bacteriological barrier properties, and
flammability were also considered.

Characteristics of studies included in the clinical effectiveness review
(Appendix D11)
Of potentially 17 eligible studies, nine studies were included that compared different methods of
draping (Alexander 1985; Alexander 1985_3; Dewan 1987; Lorenz 1988; Chiu 1993; Roberts 1995;
Bellchamber 1999; Ward 2001; Segal 2002). Reasons for exclusion are listed in Appendix F11.
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There were 3,150 patients included in the nine studies. One was conducted in the UK (Bellchambers
1999), five in the US (Alexander 1985; Alexander 1985_3;Lorenz 1988; Roberts 1995; Segal 2002),
and one in Hong Kong (Chiu 1993).All studies included adults and one study also included some
children (Dewan 1987).

A range of types of surgery were undertaken including: Caesarean section (Lorenz 1988); coronary
artery bypass graft (Roberts 1995; Segal 2002); coronary artery (Bellchamber 1999) hip fracture (Chiu
1993); abdominal procedures(Dewan,1987); and the rest did not specify the exact operation.

The following comparisons were investigated:

Disposable versus reusable paper drape (Bellchambers 1999)
Iodophor film versus solution application: two studies, 3 comparisons (Roberts 1995; Segal
2002 (two comparisons))
The GDG decided to exclude this study from the analysis because films are not used
in the UK
Plastic incise drape versus no drape: two studies (Chiu 1993; Alexander 1985_3)
Iodophor incise drape versus cloth drape or no drape: three studies, six comparisons (Dewan
1987, Segal 2002 (three comparisons), Alexander 1985 (two))
Incise adhesive drape versus standard drape (Ward 2001)
The GDG excluded this study from the analysis for SSI because the follow-up period
was only 5 days.

Some comparisons changed more than one variable at a time, these are indicated by the symbol [2V].
More specifically the comparisons were:

Plastic incise drape versus no drape or cloth drape
Plastic (polyurethane) incise drape (Opsite) versus no drape
(both arms were prepared with povidone iodine solution then draped with sterile towels;
Chiu 1993)
Ethylene methacrylate incise drape versus cloth drape
(both arms were prepared with iodophor soap (5 to 10 min scrub) then two applications of
iodophor paint; Alexander 1985_3)
Iodophor incise drape versus cloth drape or no drape
Iodophor impregnated incise drape versus no drape
(both arms used a one-step iodophor / alcohol water-insoluble film; Segal 2002)
Iodophor impregnated incise drape versus cloth drapes
(both arms were prepared with an iodophor antiseptic (Biocil) followed by alcohol; Dewan
1987)
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[2V] 2% iodine / 90% alcohol 1 min scrub then iodophor impregnated incise drape versus
povidone iodine soap (10 min scrub) then two applications of PI paint (aqueous) then cloth
drape (Alexander 1985)
[2V] One-step iodophor / alcohol water-insoluble film plus an iodophor impregnated incise
drape versus povidone iodine paint (Segal 2002)
[2V] One-step iodophor / alcohol water-insoluble film plus an iodophor impregnated incise
drape versus povidone-iodine scrub ( 5 min) then paint (Segal 2002)
[2V] 70% alcohol scrub (1 min) then iodophor impregnated incise drape versus povidone
iodine soap (10 min scrub) then two applications of PI paint then cloth drape (Alexander
1985)
[2V] 70% isopropyl alcohol wash (1 min) then iodophor impregnated incise drape versus
iodophor scrub (5 min) then iodophor wash (Lorenz 1988)

The last five comparisons changed more than one variable at a time and their results are treated with
caution.

Characteristics of studies included in the health economics review (Appendix
D11)
A total of seven studies (Anon 1979; Davis 1969; Mc Dowell 1993; Moylan 1987; Muller 1987; Murphy
1993; Vincent-Ballereau 1989) were identified in health economics review, none of which were
included in the clinical review.

Two studies (Moylan 1987; Muller 1987) assessed the cost-effectiveness of reusable and disposable
surgical gowns and drapes. Moylan (1987) compared the effects of a single gown and drape system of
either a spun laced fabric (disposable) or 280-thread-count cotton (reusable) utilised for alternate six-
week periods for 21 months. The authors evaluated a total of 2,181 clean and clean contaminated
procedures undertaken in a tertiary hospital or community hospital. Muller (1987), was in German, and
was therefore not included in the review. However, as the abstract of the study was also in English and
provided sufficient details, an overview of the study and its findings is reported here. Muller (1989)
compared the use of disposable gown and drapes with the use of conventional reusable cotton gowns
and drapes in 1033 operations using a prospective cohort study.
Five studies (Anon 1979; Davis 1969; McDowell 1993; Murphy 1993; Vincent-Ballereau 1989)
assessed the costs of reusable and disposable surgical drapes. Anon (1979) evaluated the costs of
switching from reusable to disposable drapes in a 1,200 bed tertiary hospital undertaking an average
of 1,000 surgical cases each month. In a similar study, Davis (1969) evaluated the costs of switching
from reusable muslin linen drapes to disposable drapes in the surgery and obstetrics department of a
single hospital. A similar study McDowell (1993) compared the economic implications of using three
different drape materials: FABRIC 450, a non-woven spunlaced fabric composed of 50% polyester and
50% percent wood pulp (disposable); standard linen made from a 50/50 cotton/polyester fabric
(reusable); and ComPel a tightly woven 100% polyester fabric (reusable), in an average abdominal
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operation. Using data from the literature, a survey of 30 American hospitals, and manufacturers
reports, the author estimated the costs of using each drape system for a typical abdominal operation.
Murphy 1993 compared the use of reusable and disposable drapes in a before and after study,
following a change of drape type used in a Canadian hospital. Vincent-Ballereau (1989) was in French
and was therefore not included in the review.

In addition, one member of the GDG provided a cost analysis undertaken by an NHS trust in 1994 to
compare the costs of reusable linen surgical drapes with a new single-use fabric (Kilinidrape) draping
system (NHS 1994).

Methodological quality of included studies in the clinical effectiveness review
(Appendix E11)
The method of randomisation was reported in seven studies which were all classified as adequate
(Alexander 1985; Alexander 1985_3, Bellchambers 1999; Dewan 1987; Lorenz 1988; Roberts 1995;
Segal 2002). The method was unclear in the other studies.

Allocation concealment was reported in three studies (Bellchambers 1999; Dewan 1987; Ward 1987)
of which two were partially adequate (Bellchambers 1999; Ward 1987) and one had inadequate
concealment (Dewan 1987). The latter stated that sequential numbers were taken from a random
number table located in the operating theatre. The allocation concealment was unclear in the other
studies.

Two studies (Bellchambers 1999; Segal 2002) described an a-priori power calculation. All the studies
included in the review but three (Alexander 1985_3) demonstrated baseline comparability of the
groups. The Alexander study did not report the baseline characteristics; the Bellchambers study had
significantly more patients with diabetes in the paper group and the fabric group had longer time on
ventilation; and the Ward study stated that the drapes group was older.

Loss to follow-up was unclear in one study (Alexander 1985_3), no drop outs were reported in three
studies (Roberts 1995; Lorenz 1988; Segal 2002) , 3% or less in two studies (Bellchambers 1999;
Dewan 1987) and all patients were included in the analysis in one study (Chiu 1993).

Blinding of outcome assessors was unclear with the exception of three studies where it was adequate
(Dewan 1987; Bellchambers 1999: Ward 2001).

All studies reported defined SSI as the primary outcome. One study (Roberts 1995) specifically stated
that the CDC definition was used to determine whether a wound infection was present. Other, earlier
studies published prior to the CDC guidelines had included a majority of the indicators of an infected
wound as defined by CDC. The follow up time was not stated by Lorenz 1988 and the follow up period
in Bellchambers (1999) was unclear, but appeared to include assessments up to 3 months. This
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lengthy follow-up period may have included infection scores for wounds that were not necessarily SSI.
The Ward study had a follow up period of only five days.

The risk of bias was assessed for each included study and three studies were assessed as being at
moderate/high risk of bias (Dewan 1987; Ward 2001; Bellchambers 1999). The Ward study was
excluded from the analysis for the SSI rate outcome, and the Bellchambers and Dewan studies were
considered in sensitivity analyses.

Methodological quality of studies included in the health economics review
(Appendix E11)
Both of the two cost-effectiveness analyses (Moylan 1987; Muller 1989) compared using disposable
drapes and gowns against using re-usable drapes and gowns. Neither of these studies presented
separate results for drapes and gowns, making it difficult to separate the costs and effects of gowns
and drapes individually. For Moylan (1987), the results of the effectiveness study were based on a
retrospective cohort study, and the results of their effectiveness analysis have been put into question
(Rutala 2001). For the other study (Muller 1989) only the abstract of the study was available, therefore
it was difficult to judge the quality and validity of the results of the study.

Three studies (Mc Dowell 1993; Moylan 1987; Murphy 1993) provided detailed cost analyses and
reported costs by resource category, making it easy to see which components were most resource
intensive. These studies included costs such as: purchase of drapes, sterilisation, packaging, storage,
removal and laundry costs. Two studies (Anon 1979; Davis 1969) provided very limited information on
how the analysis was performed and did not report costs by resource category, furthermore, these
studies were published in 1969 and 1979, hence the draping materials used may no longer be used in
practice.

Results

Disposable paper drape versus re-usable fabric drape
Bellchambers (1999) compared a disposable, paper drape including iodophor impregnated drape with
re-usable fabric drape and iodophor impregnated drape in 464 patients. Wounds were scored using
the ASEPSIS system. Total infection scores for each wound were calculated from daily scores
collected in the hospital together with the scores at six weeks and three months.
27/234 (11%) of patients in the paper drape group developed an infection in a leg surgical site
compared with 31/216 (14%) in the re-usable drape group; OR 0.78 (95%CI 0.45, 1.35); Figure 1.





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1 Figure 1: Disposable paper versus re-usable drape Leg wound
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The confidence interval was too wide to determine if there was a difference between the two groups
for the rate of sternal infections (OR 1.02 95%CI: 0.46, 2.29). (Figure 2).

Figure 2: Disposable paper versus re-usable drape Sternal wound
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Given the fairly wide confidence interval and the uncertainties around calculation of infection scores
definite conclusions cannot be drawn from this study

Cost-effectiveness of reusable and disposable surgical gown and drape system
Two studies assessed cost-effectiveness of reusable and disposable surgical gown and drape system
(Moylan 1987; Muller 1989). Both these studies found that the surgical site infection rate for the
reusable gown and drape system was significantly lower than for the disposable system. However, this
is inconsistent with clinical evidence from randomised trials presented above.

As shown in Table 1, Moylan (1987) found that the costs including: gowns and drapes, laundry,
handling and repair were lower with the disposable drape and gown system than when using a
reusable system for each of the three hospitals. These savings were largest with in the university
hospital and lowest in the community hospital.

Table 1. Costs of reusable and disposable surgical gown and drape system (costs $)
Community hospital University hospital Metropolitan hospital
Reusable Disposable Reusable Disposable Reusable Disposable
Laundry and repair costs
Direct
Indirect**
234,400
154,100
80,300
80,300
0
80,300
150,120
142,000
8,120
0
0
0
73,162
17,532
55,630
0
0
0
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Handling costs 94,100 7,500 126,896 0 4,550 0
Purchase costs 23,00 243,400 239,320 332,273 6,913 112,283
Other costs* 17,200 6,500 14,062 0 52,038 0
Total costs 368,700 337,700 530,398 332,273 136,663 112,283
Annual no. procedures 13,100 10,924 7,334
Cost per procedure 28.14 25.78 48.56 30.41 18.63 15.30
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* Other cost items under the reusable system were primarily disposable supplies used by these
institutions prior to conversion to a disposable system
** Indirect laundry costs were shown for the community hospital under the disposable system, as this
hospital was required to maintain the laundry operation.
Derived from Moylan et al. (1987).

Based on an analysis of costs over a 12-month period, Muller (1989) showed a reduction of 7.5%
when the disposable gown and drape system was used. No more information was available from the
abstract of this German study.

Costs of reusable and disposable surgical drape system
Four studies (Anon 1979; Davis 1969; McDowell 1993; Murphy 1993) compared the costs of reusable
and disposable surgical drapes. A further report (NHS 1994), presented by a member of the GDG,
also compared the costs of reusable and disposable surgical drapes.

Three studies concluded (Anon 1979; Davis 1969; Murphy 1993) concluded that a switch to
disposable drapes was associated with substantial cost savings. Murphy (1993) provided a very
detailed cost analysis of usage of both disposable and reusable drapes, and found that even though
disposable drapes were not a viable alternative from an environmental perspective (i.e. created less
need for incineration or landfill use than disposable drapes), they were considered to be financially
competitive (Table 2).

Table 2. Estimated annual costs of a disposable and reusable draping system (costs $)
Disposable Reusable
Year 1
Reusable
Year 2
Reusable
Year 3
Cost of drapes 515,214 196,500 125,760* 125,760*
Handling 35,537 569,036 569,036 569,036
Storage 9,900 9,900 9,900 9,900
Removal 20,250 20,250 20,250 20,250
Disposal 13,162 3,290 3,290 3,290
Subtotal 594,063 798,976 728,236 728,236
Capital equipment
outlay
15,150 15,150 15,150
Grand total 594,063 814,126 743,386 743,386
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* Costs of reusable drapes in years 2 and 3 represented the costs of replacing existing drapes.
Derived from Murphy (1993)

One study (McDowell 1993) and one report (NHS 1994) both concluded that the costs the costs of the
reusable and disposable draping systems were similar.

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Effect of a plastic incise drape
Two studies compared plastic incise drapes with either no drape (Chiu 1993) or a cloth drape
(Alexander 1985_3); Figure 3. There confidence intervals were too wide to draw conclusions.

Figure 3: Plastic incise drapes versus other drapes or none
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Effect of an iodophor impregnated incise drape

Six comparisons investigated the effect of an iodophor incise drape: Dewan (1987) compared an
iodophor drape with no drape (both groups were prepared using an iodophor antiseptic and alcohol).
Segal 2002 investigated the effect of an iodophor impregnated incise drape compared to no drape
(both groups also had an iodophor water-insoluble film). These two comparisons of iodophor drape
with no drape showed no significant difference in the rate of infection (Figure 4); OR 1.03 (95%CI 0.64,
1.64). However, it is noted that much of the weight in the meta-analysis is from the Dewan 1987 study,
which may be biased in terms of allocation concealment. The GDG agreed to downgrade the evidence
level for this meta-analysis.

The remaining comparisons changed two variables at once and were treated with caution: Alexander
(1985) compared an alcohol based PI scrub plus an iodophor drape with an aqueous PI preparation
regime plus cloth drape. Segal (2002) compared an iodophor drape plus iodophor water-insoluble film
with two aqueous solution application methods (but the two solution arms were combined here for
convenience). Alexander (1985) also compared an alcohol scrub plus iodophor drape with an aqueous
PI preparation regime plus cloth drape. Lorenz (1988) compared an alcohol scrub plus iodophor
versus a scrub plus solution iodophor (solution type not specified). In all cases there were wide
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confidence intervals so conclusions could not be drawn for any of these comparisons.

Figure 4: Iodophor drape versus cloth drape or no drape or versus iodine solution
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Cost-effectiveness
Two studies (Hagen 1995; Lorenz 1988) in the review compared the use of isopropyl alcohol cleansing
followed by the application of an iodophor-impregnated drape, with idodophor scrub and paint
preparation followed by the application of a plain adhesive drape. Both these studies found no
differences in SSIs prevented, but found that the use of isopropyl alcohol cleansing followed by the
application of an iodophor-impregnated drape was substantially faster to apply, and incurred less costs
than the idodophor scrub and paint preparation followed by the application of a plain adhesive drape.

GDG consensus
Based on the limited evidence, the GDG agreed that disposable sterile single use drapes should be
used for sterile surgical procedures that involve an incision, and that impregnated or non impregnated
incise drapes can be used if the clinician wishes.

Evidence statements and Recommendations

Level of
Evidence
Evidence Statement
1-

There is insufficient evidence to determine a difference in rates of SSI
between disposable versus reusable fabric drape.
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HE

The use of disposable surgical drapes over reusable drapes does not appear
to be associated with an increase in overall costs, and could potentially lead
to cost savings due to savings in laundry, sterilisation and labour
requirements in packing and repairing reusable drapes.

1- There is insufficient evidence to determine if there is a difference in the rate of
SSI between plastic incise drapes without antiseptics compared with other
drapes or none.

1- A meta-analysis of two studies showed little difference in the rate of infection
when an iodophor impregnated incise drape was compared with no drape.
However, much of the weight in the meta-analysis was from a study that may
be biased.

1-


HE
There was insufficient information to determine if there is a difference in rate
of SSI between an iodophor impregnated incise drape and a cloth drape or
iodine solution.
There is evidence from two studies that skin preparation with isopropyl alcohol
cleansing followed by the application of an iodophor-impregnated generated
cost savings mainly due to savings in time associated with skin preparation
time when compared to iodophor scrub and paint preparation followed by the
application of a plain adhesive drape.

4 GDG consensus was that impregnated or non-impregnated incise drapes can
be used as the clinician prefers.

1
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Grade

Recommendation
D

D
Disposable, sterile, single use drapes should be used for sterile surgical
procedures that involve an incision.
Impregnated or non-impregnated incise drapes can be used as the clinician
prefers.
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6.12 Perioperative Warming 1
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Objective
The objective of this review was to determine the clinical and cost effectiveness of perioperative
warming in preventing postoperative surgical site infection (SSI) rates.

Criteria for considering studies for this review

Type of interventions
Studies that evaluated the following interventions and comparisons were considered:
Warming therapy vs standard care pre-operatively
Warming therapy vs standard care intra-operatively
Warming therapy vs standard care post-operatively
Warming therapies considered included active/passive methods and topical warming to either site of
proposed incision (pre-operatively) or wound (post-operatively).

Studies with induced hypothermia (e.g. in cardiac surgery) were not included.

Characteristics of clinical studies included in the review (Appendix D12)
A total of 15 studies were considered for inclusion. Only two of those studies were included in the
review. Reasons for exclusion of the remaining studies are listed in Appendix F12.
Two randomised controlled studies were included (Kurz 1996; Melling 2001).

One study was conducted in the UK (Melling 2001) and the other in Australia (Kurz 1996).

There were a total of 621 adult patients in the included studies. A range of types of surgery were
undertaken including: colorectal surgery (Kurz 1996) ; breast surgery, hernia repair, or varicose vein
surgery (Melling 2001).

The following types of comparisons were investigated:
Normothermia vs routine intraoperative thermal care (Kurz 1996)
Local pre-operative warming versus no warming (Melling 2001)
Systemic pre-operative warming versus no warming (Melling 2001)

Both studies reported wound infection as a primary outcome, however, this was measured at varying
times and there were different definitions of infection. Kurz (1996) defined wound infection as presence
of pus and a positive culture. Wound infections included in the analysis were diagnosed within 15 days of
surgery. Melling (2001) defined infection as presence of purulent discharge or a painful erythema that lasted for 5
days. The time of assessment was two weeks in Kurz (1996) and two and five weeks in Melling (2001).
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One study also assessed patient comfort, length of stay, and mortality (Kurz,1996).

Characteristics of studies included in the health economic review (Appendix
D12)
Four studies were included in the cost-effectiveness review (Bock 1998, Fleisher 1998, Mahoney
1999, Wong 2004). Of these studies, none were included in the clinical review.

Three economic evaluations (Bock 1998, Fleisher 1998, Mahoney 1999) compared active warming
using forced air with conventional treatment of hypothermia. A further economic evaluation (Wong
2004) compared two different practices of maintaining patients core body temperatures; forced air
warming and radiant warming. However, there was no clinical evidence that compared forced air
warming with radiant warming using SSI as an outcome measure.

In a randomised controlled study undertaken in Germany, Bock et al. (1998) compared the cost-
effectiveness of preinduction and intra-operative warming using forced air warming in addition to
conventional treatment of hypothermia with conventional treatment for hypothermia alone in patients
undergoing abdominal surgery for cancer or inflammatory bowel disease.

Fleisher et al. (1998) compared the costs and effects of actively warming patients intraoperatively
using forced air warming to routine thermal care with warmed blankets using a randomised controlled
study undertaken in the USA. The study population in this study comprised patients undergoing
general endotracheal anaesthesia for an elective surgical procedure, who were at low risk of risk for
perioperative complications.

Using a meta-analysis of 18 studies, which included, 1,575 patients, Mahoney and Odom (1999)
assessed the costs and outcomes of maintaining intra-operative normothermia in patients undergoing
surgery.

In a randomised controlled study undertaken in New Zealand, Wong et al. (2004) compared two
different interventions of actively warming patients intra-operatively; forced air warming and radiant
warming. The study population comprised female patients undergoing laparoscopic cholecystectomy;
forced air warming and radiant warming.

Methodological quality of included clinical studies (Appendix E12)
The method of randomisation and allocation was stated and adequate in both the studies.
The outcome assessor was blinded in both studies (Kurz 1996; Melling 2001). Information on the
number of withdrawals was reported in both studies. Loss to follow-up was reported as 6% in Kurz
(1996) and 2% in Melling (2001).

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The costing studies undertaken in the four economic evaluations identified in the review each had
limitations. The costing study undertaken by Bock et al. (2000) although including all the relevant costs
of anaesthetic treatment, failed to include other costs accrued during the hospital stay (e.g. length of
stay) in their analysis. In a similar fashion, Mahoney & Odom (1999) included all relevant costs related
to adverse outcomes and costs of treating hypothermia but did not include the costs of warming
patients. The cost results from Wong et al. (2004) were not estimated using a detailed costing study,
but by assuming a cost for each resource use component (i.e. blanket, blower unit and radiant
warming). Therefore the cost results from this RCT undertaken in New Zealand need to be treated with
caution. Finally, the methods used in the costing study undertaken by Fleisher et al. (1998) are not
clearly reported, making their results difficult to quantify and understand.

Results

Primary outcome- Wound infection
One study assessed the effects of preoperative warming (Melling 2001) and one study assessed the
effect of intra-operative warming (Kurz 1996). No study that evaluated the effect of postoperative
warming was identified.

Pre-operative warming
The Melling (2001) study evaluated the effect of pre-operative warming (local and systemic) in
comparison to normothermia on the incidence of SSI after short duration clean surgery. 19 wound
infections were identified in 139 non-warmed patients (14%) but only 13 in 277 who received warming
(5%). This was a large statistically significant difference (OR 0.31 (95%CI 0.15, 0.65); number needed
to treat 11. Similar effects were found for both local warming and systemic warming (Figure 1). There
was insufficient information to determine if there was a difference in SSI rates between local and
systemic warming. ASEPSIS wound scores were also significantly lower (p=0.007) in warmed
patients. There was no significant difference in the development of haematomas or seromas after
surgery but the non-warmed group were prescribed significantly more postoperative antibiotics
(p=0.002).










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Figure 1: Pre-operative warming versus normothermia

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Intra-operative warming: normothermia (warming) versus hypothermia (control)

Primary outcome rate of SSI
The Kurz(1996) study investigated the impact of forced-air warming of upper body combined with fluid
warming to raise the temperature to normothermia (37.0
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(34.4
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assigned to hypothermia (19%) but in only 6 of 104 patients assigned to the warmed group (6%,
p=0.009).

Secondary outcomes
The sutures were removed one day later in the patients assigned to hypothermia than in those
assigned to normothermia (p=0.002). The ASEPSIS scores were also significantly lower in the
normothermia group (p=0.002).

Length of hospital stay
The duration of hospitalisation was prolonged by 2.6 days (approximately 20%) in the hypothermia
group (p=0.01).

Patient Comfort
Thermal comfort was assed on a visual analogue scale one hour after surgery. Thermal comfort was
significantly greater in the normothermia group than the hypothermia group. (Kurz,1996)

Mortality
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One study reporting on the mortality rates stated that 2 patients in the normothermia and the
hypothermia groups died during the month following the surgery (Kurz,1996). These patients died after
being admitted to the intensive care unit because of wound dehiscence, colon perforation, and
peritonitis. It is assumed the deaths were not a consequence of SSI.

Cost-effectiveness
Forced air warming vs. routine thermal care
Three economic evaluations (Bock 1998, Fleisher 1998, Mahoney 1999) compared active warming
using forced air to conventional treatment of hypothermia.

Bock et al. (2000) found that actively warmed patients required significantly less time to be discharged
from anaesthetic recovery room than those receiving conventional treatment (94+/-42min vs. 217+/-
169, respectively; p<0.01). In terms of costs, the authors only included the costs of warming and those
incurred during anaesthesia. The authors found that actively warmed patients incurred significantly
lower mean costs than did those receiving conventional treatment (408+/-105 vs. 534 +/-250;
p<0.05).

Fleisher et al. (1998) found that post-surgical emergence time, from completion of surgical dressing
until extubation, was significantly reduced in patients who were actively warmed compared to those
receiving routine thermal care (10+/-1min vs. 14+/-1min; p<0.01). In terms of cost, the results showed
that the use of forced air warming could incur an additional cost of $15 per patient over routine thermal
care, or generate savings of approximately $30 per patient, depending on assumptions about the
costing used.

Results from the meta-analysis undertaken by Mahoney & Odom (1999) found that maintaining
normothermia during an operation generated cost savings, when compared to mildly hypothermic
patients, between $2,495 and $7,074 per patient, after including treatment costs of operation, length of
stay, and adverse effects such as infection or myocardial infarction, however, the costs of warming
itself were not included.

Therefore, given the clinical evidence that pre- and intra-operative warming prevents SSIs when
compared with routine thermal care, forced air warming is likely to be highly cost-effective.

Forced air warming vs. radiant warming
One economic evaluation (Wong 2004) compared two different practices of maintaining patients core
body temperatures; forced air warming and radiant warming. The authors of this study found, that
although the costs of radiant warming were higher at first, after around 170 operations the two
warming devices were found to have the same costs, with radiant warming requiring no further
ongoing costs and consuming around half the energy of the forced air warming devices


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Evidence statements and recommendations 1
2
Level of
evidence
Evidence Statements
1+



1-
There is good evidence to suggest that preoperative warming (local or
systemic) in comparison to no warming reduces the incidence of surgical site
infection in day surgery.
There is insufficient evidence to determine if there is a difference in incidence of
wound infections between local and systemic warming.
1+



HE
There is good evidence to suggest that intra-operative warming to
normothermia, in comparison with hypothermia, reduces the incidence of
surgical site infection in major surgery.
There is evidence that pre-operative and intra-operative warming using forced
air warming generates overall cost savings when compared to routine thermal
care (e.g. use of warmed mattresses and blankets), due to reductions in the
cost of the operation and the recovery time from the anaesthetic. Therefore,
given the clinical evidence that these techniques prevent SSIs compared with
routine care, pre-operative and intra-operative warming using forced air
warming is likely to be highly cost effective.
There is limited evidence that intra-operative warming using radiant warming
generates cost savings in the long-term when compared to forced air warming
3
4



Grade

Recommendations
A


A
In major surgery, the maintenance of normothermia intraoperatively is
recommended unless there are clinical contraindications.

In minor procedures of short duration, systemic or local preoperative warming is
recommended.
5
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6.13 Perioperative Oxygen 1
2
3
4
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9
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33
34
35
36
37
38
Objective
To determine the clinical and cost effectiveness of the administration of higher concentration or
supplemental oxygen perioperatively for the prevention of postoperative surgical site infection.

Criteria for considering studies for this review
Types of intervention
Studies to be considered for inclusion will include the following interventions and comparisons:
Inspired supplemental vs standard oxygen
Inspired high concentration vs standard oxygen
Oxygen will be described as percentage, fractional inspired oxygen (FIO
2
) or as defined by the trialists

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for both clinical
and cost effectiveness are given in Appendix C13.

Characteristics of studies included in the clinical effectiveness review
(Appendix D13)
Five studies were found that met the inclusion criteria for the review: four from the initial searches
(Greif 2000; Whitney 2001; Pryor 2004; Mayzler 2005) and one subsequently published on 26 October
2005 (Belda 2005).

Two of the trials were conducted in the US (Whitney 2001; Pryor 2004), one in Spain (Belda 2005),
one in Austria and Germany (Greif 2000) and one in Israel (Mayzler 2005).

There were a total of 822 adult patients undergoing colorectal surgery (Greif 2000; Belda 2005;
Mayzler 2005), abdominal surgery (Pryor 2004), and cervical spine procedures (Whitney 2001).

Characteristics of studies included in the Health Economics review
No study was identified assessing the cost-effectiveness of the administration of higher concentration
or supplemental oxygen perioperatively for the prevention of postoperative surgical site infection.

Methodological quality of the included studies (Appendix E13)
Method of randomisation
The method of randomisation was adequate and clearly stated in four of the trials (Grief 2000; Pryor
2004; Belda 2005; Mayzle 2005) and unclear in one trial (Whitney 2001).

Allocation concealment
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33
34
35
36
37
38
39
Three of the trials reported allocation concealment (Greif 2000; Pryor 2004; Belda 2005) and was not
stated in two (Whitney 2001; Mayzler 2001). One study reported an adequate method of concealment
(Greif 2000); two reported partially adequate (sequentially numbered open envelopes (Belda 2005);
serially numbered sealed envelopes (Pryor 2004); and unclear in two studies (Mayzler 2005; Whitney
2001).

Blinding of outcome assessors
With the exception of Whitney (2001) the four other trials reported on blinding (Greif 2000; Pryor 2004;
Belda 2005; Mayzler 2005).

Baseline comparability of groups
Comparability of groups at entry was demonstrated for four of the trials (Greif 2000; Whitney 2001;
Belda 2005; Mayzler 2005). In one trial (Pryory 2004) the groups were comparable on most indices at
the start of the study. However, those having 80% oxygen had a significantly higher mean body mass
index than those on 35% oxygen, and a higher proportion of patients in this group were obese (defined
as BMI>30; 19% vs. 9%).

Length of follow-up
All five trials reported on length of follow-up, with three trials reporting two weeks (Greif 2000; Pryor
2005; Belda 2005) and two reporting a follow-up period of a month (Whitney 2001; Mayzler 2005).

Loss to follow-up was reported in three studies (Greif 2000; Pryor 2004; Belda 2005) and unclear in
two studies (Whitney 2001; Mayzler 2005). Withdrawals was reported as follows: 0.6% (Greif 2000),
3% (Belda 2005) and 6% in the 80% O
2
group (Pryor 2004).

Results
Greif (2000) included 500 patients found a lower rate of infection among patients treated with 80%
oxygen than among those on 30% oxygen: 13/250 (5.2%) had an infection on 80% O
2
vs. 28/250
(11.2%) on 30% O
2
, p=0.01. The mean ASEPSIS score (where a higher score represents poorer
healing and a greater likelihood of infection) was also better on the higher dose of oxygen: 3 (7) on
80% O
2
vs. 5 (9) on 30% O
2
, p=0.01. Length of stay was 12.2 (6.1) on 80% O
2
vs. 11.9 (4.0) on 30%
O
2
, p=0.26 and mortality was 1/250 (0.4%) on 80% O
2
vs. 6/250 (2.4%) on 30% O
2
, p=0.13.

Belda (2005) involved 300 patients found a lower rate of infection among patients treated with 80%
oxygen than among those on 30% oxygen: 22/148 (14.9%)compared with 35/143 (24.4%), p=0.04.
The number of patients scoring over 20 on the ASEPSIS score was lower on 80% oxygen: 25/148
(16.9%)compared with 37/143 (25.9%). Length of stay was 11.7 (7.0) on 80% O
2
vs. 10.5 (4.4) on
30% O
2
, p=0.09.

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Pryor (2004) involved 160 patients, based on a power calculation that assumed a substantial 40%
difference between the groups. During surgery, the O
1
2
3
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7
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9
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32
2
could be increased as required by the
anaesthetist to maintain the patients oxygen saturation at >94%, as measured by pulse oximetry. It is
therefore not clear how much oxygen the patients actually received during the operations. These
investigators reported more, rather than fewer infections among the group receiving the higher dose of
oxygen: 20/80 (25%) on 80% O
2
vs. 9/80 (11.3%) on 35% O
2
, p=0.02. They also found no significant
difference between the two groups in the length of stay: 8.3 (7.5) days on 80% O
2
vs. 6.4 (4.7) days on
35% O
2
, or the mortality: none died on 80% O
2
; 1/80 died on 35% O
2
. The difference in weight of the
patients in the two groups, the difference in other risk factors, plus the allowed variation in the amount
of oxygen administered, make these results hard to interpret with certainty. Therefore this study was
regarded as poorer quality evidence and investigated in a sensitivity analysis.

Mayzler (2005) was a small study of only 38 patients. No power calculation was presented but it is
apparent that this study was underpowered, since this study had only 5 infection events, 3 in one
group and 2 in the other.

The fifth study, Whitney (2001), was a small pilot study of only 24 patients who were undergoing
cervical spine surgery and were treated with 28% oxygen for 36 hours after operation, or maintained
on room air. This was a much lower dose of oxygen than was used in the other three studies (28%
versus room air, rather than 80% versus 30%), so it would not be appropriate to combine this in the
meta-analysis with the other studies. All patients had ASEPSIS score in the range of satisfactory
healing (0-10); no significant differences were found between the mean scores of the groups. As the
raw data were not available, this could not be shown.

Analysis of the Pryor (2004), Belda (2005), Greif (2000) and Mayzler (2005) studies showed significant
heterogeneity (I
2
=76%), attributable to the Pryor (2004) study. This was not surprising in view of the
lack of comparability between the groups in the Pryor (2004) study, and the lack of clarity about the
actual quantities of oxygen the patients received during their operations. Therefore, the other studies
were combined excluding the Pryor (2004) study. The data are displayed in the meta-analysis in
Figure 1.

Figure 1
33
34
35
36

Thus the odds of having an infection on 80% oxygen is half that for 30% oxygen. This corresponds to
a number needed to treat of 14.
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1
2
3
4
5

In addition to the proportions of patients having an infection, Greif (2000) also reported the mean
ASEPSIS score of the patients (Figure 2)

Figure 2
6
7
8
9
10
11
12
13
14
15
The higher oxygen level resulted in a mean decrease of 2 units.

Length of stay was reported by Belda (2005), Greif (2000) and Pryor (2004). None showed a
significant difference between the groups. The results of Belda (2005) and Greif (2000) were combined
in meta-analysis (Figure 3) but Pryor (2004) was not combined because of the uncertainties about its
methodological quality.

Figure 3

16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32

Mortality was reported by Greif (2000) and Pryor (2004) and neither showed a significant difference
between the groups. These studies were not combined in meta-analysis because of the uncertainties
about the Pryor (2004) study quality.

Cost-effectiveness
No study assessed the cost-effectiveness of the administration of higher concentration or
supplemental oxygen perioperatively.

However, the clinical review showed a substantial statistically significant lower rate of infection when
80% oxygen was used perioperatively compared to 30% oxygen. Therefore, taking into account that
the additional costs of treating a patient with a surgical site infection are, on average, 3,313 per
patient (Coello 2005), the perioperative administration of higher concentration or supplemental oxygen
is likely to be highly cost-effective.


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Evidence statement and recommendations 1
2
Level of
evidence
Evidence Statements
1++


HE
Meta-analysis of three studies showed a significantly lower rate of infection
when 80% oxygen is used perioperatively compared to 30% oxygen

Taking into account that the additional costs of treating a patient with a surgical
site infection are, on average, 3,313 per patient, the perioperative
administration of higher concentration oxygen is likely to be highly cost-
effective.

1- There was insufficient information in a small study comparing 28% oxygen with
air.





Grade

Recommendation
A 80% oxygen should be used perioperatively in major surgery except where
clinically contraindicated

3
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6.14 Intra-cavity solutions 1
2
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31
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33
34
35
Objective
To determine the clinical and cost effectiveness of various solutions used for irrigating wounds for the
reduction of surgical site infections

Criteria for considering studies for this review
Types of comparison
The following types of comparison were investigated:
Irrigating solution versus no solution
Irrigating solution 1 versus irrigating solution 2

Characteristics of clinical studies included in the review (Appendix D14)
The review identified seven potentially eligible studies, of which four were included (Magann 1993;
Baker 1994; Anglen 2005; Cheng 2005). Reasons for exclusion of studies are listed in Appendix D14.

A total of 1214 patients were included in the four studies. One study was conducted in the UK
(Magann 1993), two in the US (Baker 1994; Anglen 2005), and one in Taiwan (Cheng 2005).

Patients had undergone a range of types of surgery including: caesarean section (Magann 1993),
colorectal surgery (Baker 1994), delayed union of open fracture of the pelvis or lower extremity
(Anglen 2005) and spinal surgery (Cheng 2005).

The following types of comparisons were investigated:
Irrigation versus no irrigation
There were no studies identified that investigated this comparison.
Irrigation solution 1 versus irrigation solution 2: four studies, with five comparisons (Anglen
2005, Baker 1994, Cheng 2005; Magann 2005 (two comparisons)).
Dilute 3.5% betadine (0.35% povidone iodine in 142 ml saline followed by irrigation with 1
litre saline versus 1 litre saline (Cheng 2005)
Solution containing antibiotic additives (bacitracin) versus detergent solution (non-sterile
castile soap solution) (Anglen 2005)
Antibiotic (cefazolin sodium in saline) versus no irrigation (Magann 1993; two
comparisons, with different skin preparation methods)
2% taurolidine (antimicrobial) in 5% polyvinyl pyrrolidine versus normal saline (Baker
1994)
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Methodological quality of included clinical studies (Appendix E13) 1
2
3
4
5
6
7
8
9
10
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13
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17
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23
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27
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29
30
31
32
33
34
35
36
37
38
39
40
The method of randomisation was reported and adequate in two studies (Magann 1993; Baker 1994),
and unclear in two studies (Anglen 2005, Cheng 2005).

Allocation concealment was reported in three studies and was classified as adequate in one (Baker
1995) and partially adequate in two studies (Magann 1993; Cheng 2005). The other study (Anglen
2005) was classified as unclear the study reported that a card was drawn from envelopes kept in the
emergency department.

Blinding of outcome assessors was reported in two studies and was classified as adequate in one
(Baker 1994), and mainly adequate in one study (Anglen 2005). The other studies did not discuss
blinding (Magann 1993; Cheng 2005).

Baseline comparability was stated in three of the studies (Magann 1993; Baker 1994; Cheng 2005)
and was not comparable for some characteristics in one study (Anglen 2005): patients were
significantly older in the soap group and more had hypotension in the antibiotics group.

Loss to follow-up was reported in two studies (Baker 1994; Anglen 2005) at 9% and 12% overall
respectively. Two studies did not report on loss to follow-up (Magann 1993; Cheng 2005).

Results

Irrigation solution 1 versus irrigation solution 2

Primary outcome rate of SSI
The four studies compared different solutions and no comparisons could be combined in a meta-
analysis. The individual comparisons, shown in figure 1, were:
Bacitracin antibiotic solution versus castile soap irrigation using a power irrigator system
(Anglen 2005)
Irrigation with cefazolin antibiotic in saline versus saline (the study also randomly split the
groups into two skin preparation methods, but these were combined for this analysis) (Magann
1993)
2% taurolidine (antimicrobial) in 5% polyvinyl pyrrolidine versus saline (Baker 1994)
Dilute 3.5% Betadine solution (0.35% povidone iodine in saline; 142 ml) then irrigation with 2
litres saline versus 2 litres saline alone (wounds were soaked with betadine for three minutes)
(Cheng 1995).

The first three irrigation comparisons had confidence intervals that were too wide to determine if there
was a difference between interventions. However, although the confidence interval was wide for the
Cheng study, there were statistically significantly fewer SSIs for the povidone iodine solution followed
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1
2
3
4
by saline compared with saline alone; Peto OR: 0.13 (95%CI 0.03, 0.58); number needed to treat was
33.

Figure 1: irrigation solution 1 versus solution 2 rate of SSI
5
6
7
8
9
10
11
12

GDG consensus
In the absence of much evidence, GDG consensus was that sterile saline warmed to 37
o
C should be
used for irrigation of body cavities, if clinically indicated.

Evidence statements and recommendation

Level of
Evidence
Evidence Statement
1-


1-
There was insufficient evidence to show if there was a difference in the
rate of SSI between irrigation with bacitracin antibiotic solution
compared with a soap solution.
There was insufficient evidence to show if there was a difference in the
rate of SSI between irrigation with cefazolin antibiotic in saline
compared with saline solution.
1- There was insufficient evidence to show if there was a difference in the
rate of SSI between taurolidine (antimicrobial) in polyvinylpyrroline
solution and saline.
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1+ There is fair evidence to suggest that an intracavity dilute solution of
povidone iodine decreases the incidence of SSI in spinal surgery.
4 GDG consensus was that, if clinically indicated, body cavities should be
irrigated with warmed (37

C), sterile saline.


1
2



Grade

Recommendations
GPP

A
If clinically indicated, body cavities should be irrigated with warmed
(37

C), sterile saline


Intracavity irrigation with dilute solution of povidone iodine in saline is
indicated in adult orthopaedic surgery
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6.15 Intra operative skin antiseptics 1
2
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9
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15
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30
31
32
33
34
35
36
37
Objective
The objective of this review is to determine whether the use of intraoperative skin antisepsis
immediately prior to wound closure reduces the incidence of post-operative surgical wound infection.

Criteria for considering studies for this review

Types of interventions
There are three major types of antiseptics:
Iodine/Iodophors: their mode of action is by cell wall penetration, oxidation and substitution of
microbial contents with free iodine. Iodophors are solutions of iodine with a surfactant /
stabilising agent that liberates the free iodine. One commonly used iodophore is povidone
iodine (PI), a complex of iodine with poly(1-Vinyl-2-pyrrolidinone)
Alcohol, which denatures the cell wall proteins of bacteria. Concentration rather than type of
alcohol is more important in determining its effectiveness.
Chlorhexidine gluconate, which is thought to have a broad spectrum of activity

Types of comparison

Studies were considered in which antiseptics were applied during the operative procedure and prior to
closure of the surgical wound.
The following comparisons were included:
One or more antiseptics (solution / powder / drape) versus a control
One type of antiseptic versus another type of antiseptic
One antiseptic applied more than once versus the same antiseptic in a single application
One antiseptic applied more than once versus another antiseptic applied more than once.

Data extraction specific to this review
Details on type of antiseptics and undesirable adverse consequences, for example toxicity or allergies
were included.

Search strategy for identification of studies
Details of the general approach to searching are reported in section 5.3. The searches for both clinical
effectiveness and health economics reviews are given in Appendix C15.

Characteristics of clinical studies included in the review (Appendix D15)
Twelve studies were identified for potential inclusion of which three studies were included (Gray 1981;
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2
3
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7
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15
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23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Walsh 1981; Cordtz 1989). Reasons for exclusion are listed in Appendix F15. There were no studies
identified in the health economics review.

There were a total of 2123 patients in the three studies undergoing surgical procedures including
emergency and elective Caesarian section (Cordtz 1989) and abdominal procedures (Gray 1981;
Walsh 1981). One study was conducted in the UK (Gray 1981), one in Denmark (Cordtz 1989) and
one in Australia (Walsh 1981).

The following comparisons were investigated:
Redisinfection with 2.5% iodine in 70% ethanol versus no disinfection (Cordtz 1989)
Redisinfection with 2.5% iodine in 70% ethanol with incise drape versus no disinfection with
incise drape (Cordtz 1989)
(all of the four groups skin prepared with 2.5% iodine in 70% ethanol prior to surgery)
Redisinfection with dry power povidone iodine spray versus no redisinfection (Gray 1981)
(both groups skin prepared with Chlorhexidine gluconate in 70% alcohol prior to surgery)
Spraying with povidone iodine solution versus no disinfection (Gray 1981)
(both groups skin prepared with povidone iodine prior to surgery)

All three studies reported wound infection but definition and timings of assessment varied. Gray (1981)
classified infection as either major (copious purulent discharge) or minor (scanty discharge of pus) and
wounds were assessed 5-7 days and 2 weeks after surgery. Walsh (1981) considered a wound to be
infected if a purulent discharge appeared within one month of operation. Wounds were considered
infected if there was presence of pus or localized erythema at the fourteenth post-operative day in
Cordtz (1989).

Methodological quality of included clinical studies (Appendix E15)
The generation of the randomisation sequence was described and adequate in one study (Walsh
1981). The method of randomisation was unclear in Gray (1981) (advent calendar) and in Cordtz
(1989).

The method of allocation concealment was unclear in all three trials. No details of power calculation
were described in the included studies.

Two studies (Gray 1981; Walsh 1981) reported no bias in comparability of the baseline characteristics
of the groups. No description was given in the study by Cordtz (1989).

In one study it was unclear whether assessors in the hospital were blind to allocation (Cordtz 1989). In
the study by Gray (1981) it was inadequate as the house surgeon conducted the assessment. Walsh
(1981) stated that the treatment allocation was double blind. An infection control nurse who was
unaware of treatment allocation assessed each wound at the end of the operative procedure.
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2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25

All three studies reported SSI as the primary outcome measure, however, the definition of wound
infection varied between the three studies. Cordtz (1989) assessed SSI by the presence of localised
erythema and or serous secretion with out the presence of pus. This was categorised as possibly
infected. Infected sites were classified if there was pus present irrespective of the results of
bacteriology. Data has been analysed for infected sites only. Gray (1981) classified infection as a)
major with copious purulent discharge; b) minor with scant discharge of pus. Data have been analysed
for major infection only. Walsh (1981) defined infection as: purulent discharge present with or without
bacteriological analysis or serosanguinous discharge positive on culture. Follow-up was two weeks in
two studies (Gray 1981; Cordtz 1989) and one month in Walsh (1981).

Loss to follow up was not stated in two studies (Walsh 1989; Codtz 1989) and was reported at 2% in
Gray (1981).

Results
The antiseptics differed between the three studies, however, all evaluated some form of iodine.

Redisinfection with iodine versus no redisinfection
Cordtz (1989) compared redisinfection to no redisinfection. All patients received a preoperative
antiseptic solution of 2.5% iodine in 70% ethanol and were then randomised to redisinfection versus
no disinfection, together with incise drapes versus no drape. Combining the two comparisons in a
meta-analysis (Figure 1) showed a non-significant improvement in SSI rates for the iodine
redisinfectant group (OR 0.77 (95% CI: 0.56, 1.07)).

Figure 1: iodine versus no disinfection rate of SSI
26
27
28
29
30

Redisinfection with povidone iodine spray versus no redisinfection

Two studies compared redisinfection with povidone iodine spray (Gray 1981, Walsh 1981). In the Gray
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study, patients skin was prepared with chlorhexidine gluconate in 70% alcohol and then either
redisinfected with dry powder povidone iodine spray or no redisinfection. In the study by Walsh (1981)
standard skin preparation with povidone iodine was used. Following closure of the peritoneum,
patients were randomised to either redisinfection with povidone iodine spray or no redisinfection.
Combining the studies in a meta-analysis (Figure 2) showed a non-significant improvement in SSI
rates for the iodine group (OR 0.65 (95% CI: 0.40, 1.04); p=0.08).

Figure 2: povidone iodine redisinfection versus no redisinfection rate of SSI
9
10
11
12
13
14
15
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20
21
22
23
24
25
26
27


















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Evidence statements and recommendations 1
2
Level of
evidence
Evidence Statements
1+

1+

HE
There is good evidence to show that iodine in alcohol redisinfection did not
affect the rate of SSI.
There is fair evidence to show that dry powder povidone odine spray
redisinfection did not affect the rate of SSI.

There is no health economic evidence to support or refute the practice of
redisinfection of surgical sites during operative procedures
3

Grade

Recommendation
A
Re-disinfection of the wound prior to final skin closure is not indicated
4
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6.16 Drains for the prevention of surgical site infection 1
2
3
4
5
6
7
8
9
10
11
12
13



Objective

To determine the effectiveness of drains inserted intraoperatively and managed postoperatively for the
prevention of surgical site infections.

GDG consensus
The GDG consensus was that drains are not used for the prevention of surgical site infection in the
UK any more. They are put in place for other surgical reasons, such as the removal of exudate, and
may potentially cause infection. Therefore this review was not carried out.
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Introduction
One relevant Cochrane review (Coulthard P, Worthington H, Esposito M, van der Elst M, van Waes
OJF. Tissue adhesives for closure of surgical incisions. The Cochrane Database of Systematic
Reviews 2002, Issue 3. Art. No.: CD004287) was found and updated to January 2006.

Objective
To determine the clinical and cost effectiveness of using different methods and materials for closing
wounds in the prevention of postoperative surgical site infection.

Criteria for considering studies for this review

Types of comparison
The following types of comparison were investigated:
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Closure of the skin
1. Suture material 1 versus suture material 2 (silk, nylon, absorbable, mono/multi filament,
coated/non-coated)
2. Suturing technique 1 versus suture technique 2 (e.g. interrupted/continuous)
3. Non-suture versus suture closure material (e.g. tape, staples, mesh, tissue adhesive)
4. Non-suture closure material 1 versus non-suture closure material 2
5. Timing of skin closure 1 versus timing 2

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Closure of internal layers
6. Suture material 1 versus suture material 2
7. Suturing technique 1 versus suture technique 2
8. Suture type 1 versus suture type 2 (e.g. mesh/suture)
9. Other comparisons

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Internal intervention versus external intervention

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Closure of bone
10. Closure material 1 versus closure material 2
11. Closure technique 1 versus closure technique 2

Search strategy for identification of studies
Details of the general approach to searching are reported in section 5.2. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C17. It is
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noted that separate searches were carried out under the headings of sutures, non-suture methods of
closure and tissue adhesives.

Data extraction specific to this review
Details of the intervention: type of suture material (e.g. silk, nylon, absorbable, mono/multi filament,
coated/non-coated); type of suture technique (e.g. continuous, interrupted); type of non-suture closure
materials (e.g. staples, adhesive tape, tissue adhesive); type of tissue adhesive (butylcyanoacrylate
and octylcyanoacrylate); type of closure method (e.g. delayed/primary). . Further information on the
various types of suture material is included in Appendix 1 of this section.

Details of the outcomes reported, including method of assessment and time intervals. In particular,
secondary outcomes relevant to closure other than SSI rate, such as dehiscence and cosmetic
appearance. The latter was included if the authors stated that it was measured on a validated scale.

Characteristics of clinical studies included in the review (Appendix D17)
The review identified 279 potentially eligible studies, of which 70 were included (Anatol 1997; Angelini
1984; Angelini 1985; Arroyo 2001, Beresford 1993; Bhatia 2002; Bottio 2003; Cahill 1989; Cameron
1987; Carlson 1995; Cheng 1997; Chowdhury 1994; Chugtai 2000; Cohn 2001; Colombo 1997;
Corder 1991; Efem 1988; Eldrup 1981; Fagniez 1985; Farnell 1986; Gainant 1989; Gennari 2004;
Gislason 1995; Greene 1999; Grgi 2002, Gys 1989; Harvey 1986; Hiramatsu 1998; Hsiao 2000;
Jallali 2004; Johnson 1997; Karabay 2005; Keng 1989; Khammash 1994; Korenkov 2002; Krukowski
1987; Leaper 1985a; Leaper 1985b; Maartense 2002; Maffuli 1991; Magann 2002; McNeill 1986;
Mullen 1999; Murphy 1995; Murphy 2004; Mylonas 1991; Nasir 2001; Negri 2002; Niggebrugge1999;
Ong 2002; Onwuanyi 1990; Orr 1990; Orr 2003; Osther 1995; Ozturan 2001; Ranaboldo 1992; Rink
2000; Risnes 2001; Risnes 2002; Roolker 2002; Sadick 1994; Sahlin 1993; Sebesta 2003; Shamiyeh
2001; Sinha 2001; Toriumi 1998; van den Ende 2004; Velmahos 2002; Wetter 1991; Wolterbeek
2002). One study (Risnes 2002) reported two trials. Reasons for exclusion of studies are listed in
Appendix F17.

20,851 patients were included in the 69 studies. Study size ranged from 20 to 3282; two studies had
20 patients (Greene 1999, Harvey 1986), ten studies had more than 500 patients (Bottio 2003 (700);
Colombo 1997 (614); Fagniez 3035; Farnell 1986 (3282 incisions); Gilason 1995 (599); Krukowski
1987 (757); Magann 2002 (964); Negri 2002 (1000); Sahkin 1993 (988); Wetter 1991 (650)).

Thirteen studies were conducted in the UK (Angelini 1984; Angelini 1985; Cahill 1989; Cameron 1987;
Keng 1989; Krukowski 1987; Jallali 2004; Leaper 1985a; Leaper 1985b; Mylonas 1991; Ranaboldo
1992; Sinha 2001; Wetter 1991); two were carried out in: Ireland (Murphy 1995; Harvey 1986). The
rest, where it was stated, were carried out in Austria (1), Spain (1), Italy (5), France (2), The
Netherlands (4), Germany (2), Belgium (2), Denmark (3), Norway (4), Sweden (1), the USA (12),
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Croatia (1), Trinidad (Anatol 1997), Nigeria (2), India (Chowdhury 1994), Turkey (2), Hong Kong (1),
Singapore (1), Taiwan (1), Japan (1), Kuwait (1), Iraq (1), Australia (2).

All studies included adults except for five (Anatol 1997, Cheng 1997; Ong 2002; Toriumi 1998; Van
den Ende 2004) that were exclusively in children and another two (Chowdhury 1994, Efem 1988) that
were in adults and children. In four studies wounds rather than patients were randomised (Cahill 1989,
Leaper 1985a, Murphy 1995, Anatol 1997).

There was a range of types of surgery from minor operations (e.g. to remove benign skin lesions from
the back) to major operations (e.g. for extensive cancer). Some operations were classified as clean,
others clean/contaminated, contaminated or dirty (e.g. where abdominal trauma such as a gunshot
wound has opened the bowel). All studies were of parallel group design except two that were of split
body design (Greene 1999, Harvey 1986) and one that randomised the upper and lower parts of the
wound (Johnson 1997). The tissue adhesives studies excluded surgical procedures on high tension
sites such as the elbow and knee.

Twelve studies included in the review had three or more relevant comparison arms (Anatol 1997,
Angelini 1984; Angelini 1985; Cahill 1989; Farnell 1986; Gislason 1995; Korenkov 2002; Maartense
2002; Magann 2002; Mullen 1999; Shamiyeh 2001; Murphy 1995), resulting in 110 comparisons
overall. The following types of comparison were investigated:

A) Skin Closure

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Suture material 1 versus suture material 2
non-absorbable sutures versus absorbable sutures: six studies (Angelini 1984, Angelini 1985,
Corder 1991, Karabay 2005; Leaper 1985a, Murphy 1995)
Nylon (Ethilon) monofilament versus polyglyconate monofilament (Maxon) (Murphy 1995;
wounds randomised)
Polypropylene (Prolene) monofilament versus polydioxanone monofilament (Leaper 1985a,
wounds randomised)
Nylon monofilament versus polyglycolic acid multifilament (Angelini 1984, Angelini 1985,
Corder 1991)
Continuous vertical mattress 2.0 versus continuous subcuticular 2.0 (Angelini 1984,
Angelini 1985), i.e. more than one variable changing at once (material, type, filament
type, technique)
Interrupted mattress versus subcuticular 3.0 (Corder 1991)
i.e. more than one variable changing at once (material, technique, filament type)
Polypropylene (Prolene) monofilament interrupted mattress versus polycaprolactate
subcuticular multifilament (Karabay 2005)
i.e. more than one variable changing at once (material, filament type)
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absorbable suture material 1 versus absorbable suture material 2: one study (Anatol 1997)
plain catgut versus 3.0 polyglactin (Vicryl) both subcuticular sutures (Anatol 1997) - this study
was excluded from the analysis by the GDG because catgut is obsolete in the UK

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Suturing technique 1 versus suture technique 2
It is noted that the transcutaneous suture technique can also be described as an interrupted mattress
or percutaneous or transdermal suture technique. The intracutaneous technique is alternatively
called a subcuticular suture technique.

Continuous versus interrupted sutures (Murphy 1995)
Nylon continuous versus nylon interrupted for skin closure; wounds randomised (Murphy
1995)
Subcuticular (absorbable) versus interrupted mattress (non-absorbable) suture (Corder
1991, Karabay 2005, Risnes 2001, Risnes 2002a)
Polyglycolic acid absorbable multifilament versus nylon non-absorbable monofilament (Corder
1991), i.e. more than one variable changing at once (material, filament type, technique)
Polycaprolactate absorbable multifilament versus polypropylene (Prolene) non-absorbable
monofilament (Karabay 2005), i.e. more than one variable changing at once (material, filament
type, technique)
Poliglecaprone absorbable versus polyamide non-absorbable (Risnes 2001, Risnes 2002a) ,
i.e. more than one variable changing at once (material, technique)
Subcuticular nylon (non-absorbable) versus interrupted transdermal nylon (non-absorbable)
sutures (Onwuanyi 1990)
Subcuticular nylon (non-absorbable, monofilament) versus vertical mattress polyglycolic acid
(absorbable) sutures (Angelini 1984, Angelini 1985)
More than one variable changing at once (type and material of sutures)
Bilayer versus vertical mattress sutures (Sadick 1994)
Both arms appeared to use the same suture material

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Non-suture closure material versus suture
Staples versus skin sutures: 12 studies, 13 comparisons (Angelini 1984 (two comparisons),
Beresford 1993, Bhatia 2002, Chughtai 2000, Eldrup 1981, Grgi 2002, Harvey 1986, Johnson
1997, Murphy 2004, Mullen 1999, Ranaboldo 1992, Wolterbeek 2002)
The Harvey study had within patient randomisation
The Johnson study had within wound (upper/lower) randomisation
Zipper versus suture: two studies (Risnes 2002b, Roolker 2002)
this comparison was excluded from the analysis by the GDG because zippers are not used in
the UK
Tissue adhesive versus suture: nine studies (Cheng 1997; Greene 1999; Jallali 2004, Keng
1989; Maartense 2002; Ozturan 2001; Shamiyeh 2001; Sinha 2001; Toriumi 1998)
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Butylcyanoacrylate (Histoacryl) versus 4.0 catgut suture (Cheng 1997) - this study was
excluded from the analysis by the GDG because catgut is obsolete in the UK
Butylcycanoacrylate (Histoacryl) versus Dexon subcuticular suture: one study (Keng 1989)
n-butyl 2-cyanoacrylate adhesive (Indermil) versus 4.0 monofilament suture: one study (Sinha
2001)
Butylcyanoacrylate (LiquiBand) versus 6.0 polypropylene sutures after the majority of the
tension had been taken up using 5.0 chromic catgut (Ozturan 2001)
n-butylcyanoacrylate (Indermil) versus 5.0 Vicryl intracutaneous sutures (Van den Ende 2004)
Octyl-2-cyanoacrylate versus 5.0 or 6.0 nylon suture (stratified into with or without
subcutaneous sutures) (Toriumi 1998)
Octyl-2-cyanoacrylate (Dermabond) versus 6.0 suture (10 fast-absorbing gut or 10
polypropylene, Prolene) (Greene 1999)
Octylcyanoacrylate versus subcuticular 4.0 or 5.0 monofilament suture (Gennari 2004
(material not specified); Ong 2002 (Monocryl); Shamiyeh 2001 (material not specified))
Octylcyanoacrylate (Dermabond) versus intracutaneous polyglecaprone (Monocryl) interrupted
sutures (Maartense 2002)
Tissue adhesive absorbent dressing (Op-site) versus suture: two studies (Angelini 1984,
Angelini 1985)

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Non-suture closure material 1 versus non-suture closure material 2
Tissue adhesive versus adhesive tape: two studies (Maartense 2002; Shamiyeh 2001)
Both studies used octylcyanoacrylate as the tissue adhesive
Tissue adhesive versus staple: one study (Angelini 1984)

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Timing of closure 1 versus timing 2
Delayed versus primary suture: five studies (Cohn 2001, Hiramatsu 1996, Khammash 1994,
Maffulli 1991, Velmahos 2002)
Delayed closure with wounds packed with gauze versus primary closure with staples (Cohn
2001)
Povidone iodine gel administered then suture versus open wound treated with absorbent
towels (Hiramatsu 1996)
i.e., two variables changing at once (antiseptic and delay/primary)
Skin and subcutaneous layers left open with loose prolene sutures + gauze versus same
procedure but sutures were tightened (Khammash 1994)
Silk suture versus no suture and then bandaging (Maffulli 1991)
Wounds left open and packed with saline soaked dressings versus staples (Velmahos 2002)

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Other comparison
Wire retention suture versus none: one study (Rink 2000)
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this comparison was excluded from the analysis by the GDG because wire retention sutures
are obsolete in the UK

B) Closure of Internal layers

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Suture material 1 versus suture material 2
non-absorbable suture material versus absorbable suture material : 11 studies (Cameron
1987, Carlson 1995, Chowdhury 1994, Corder 1991, Gys 1989, Krukowski 1987, Leaper 1985b,
McNeill 1986, Mylonas 1991, Orr 2003, Osther 1995)
Nylon monofilament versus chromic cat gut, for peritoneum and muscle (Chowdhury 1994) -
this study was excluded from the analysis by the GDG because catgut is not used in the UK
Nylon (Ethilon) monofilament versus polyglyconate monofilament (Maxon) (Carlson 1995
(abdominal wall closure), Gys 1989 (all layers))
Nylon versus polydioxanone (Leaper 1985b)
Polypropylene (Prolene) versus polydioxanone (Cameron 1987, Krukowski 1987); both
interrupted monofilament
Stainless steel wire monofilament interrupted versus polyglycolic acid No.2 coated with
polaxamer 188 multifilament continuous, for fascial closure (McNeill 1986) - this study was
excluded from the analysis by the GDG because stainless steel is not used in the UK for
closure
Polypropylene (Prolene) monofilament versus poly(L-lactide/glycolide) multifilament for fascial
closure (Orr 2003) - more than one variable changing at once (material, filament type)
Neurilon interrupted for all layers versus polydioxanone continuous monofilament for all layers
except skin and subcuticular vicryl for skin (Mylonas 1991) - more than one variable changing
at once (material, technique, skin closure material)

Non-absorbable suture material 1 versus non-absorbable suture material 2
Nylon darn monofilament versus polybutester darn (Cahill 1989) - this comparison was
excluded from the analysis by the GDG because nylon darn is no longer used for hernia repair
in the UK
Nylon darn monofilament versus polytetrafluoroethylene darn (Cahill 1989) - this comparison
was excluded from the analysis by the GDG because nylon darn is no longer used for hernia
repair in the UK
Polybutester darn versus PTFE darn (Cahill 1989)

Monofilament absorbable suture material versus multifilament absorbable suture material:
five studies (Colombo 1997, Hsiao 2000, Osther 1995, Sahlin 1993, Wetter 1991)
polyglyconate (Maxon) late-absorbable interrupted monofilament versus polyglycolic acid
(Dexon) early-absorbable multifilament interrupted for fascial closure (Osther 1995); this study
changes three variables at once (material, time of absorption and filament type)
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polydioxanone (PDS) continuous monofilament versus polyglactin 910 (Vicryl) continuous
multifilament for fascial closure (Hsiao 2000); this study changes two variables at once
(material and filament type)
polyglycolic acid (Dexon) for all lower layers + polyglycolic acid for subcuticular skin closure
versus catgut for all lower layers + nylon for subcuticular skin closure (Wetter 1991); this study
was excluded from the analysis by the GDG because catgut is obsolete in the UK
continuous monofilament polyglyconate versus interrupted multifilament polyglycolic acid
(Colombo 1997); this study changes three variables at once (material, technique, filament
type)
polyglyconate 2.0 continuous monofilament (Maxon) versus polyglactin 910 (Vicryl) interrupted
multifilament (Sahlin 1993); this study changes three variables at once (material, technique
and filament type).

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Suture technique 1 versus suture technique 2
Continuous versus interrupted: four studies (Colombo 1997 (mass closure), Fagniez 1985
(fascia closure), Gislason 1995 (mass closure), Orr 1990 (fascia closure))
The study compared continuous monofilament polyglyconate with interrupted multifilament
polyglycolic acid (i.e. changing more than one variable at once) (Colombo 1997). In the
other studies the same suture material was used for each arm.
Mass continuous versus layered closure: one study (Efem 1988)
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The layered closure arm used catgut, so this study was excluded from the analysis by the
GDG
Continuous loop versus continuous mass closure (both arms used polypropylene): one
study (Nasir 2001)
Continuous loop versus continuous running suture: one study (Niggebrugge 1999);
polydioxanone suture were used for both arms

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Method of closure 1 versus method of closure 2
Mesh versus suture: two studies (Arroyo 2001, Korenkov 2002)
Mesh versus skin graft: one study (Korenkov 2002)
Suture versus skin graft: one study (Korenkov 2002)
Open versus suture: one study (Magann 2002)
Open versus drain: one study (Magann 2002)
Suture versus drain: one study (Magann 2002)

C) Closure using an internal intervention and an external intervention:
Internal polyglactin mesh versus external polyamide mesh: one study (Gainant 1989)
Primary closure versus subcutaneous catheter, with and without irrigation): one study
(Farnell 1986)

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D) Methods of securing bones
Bone clips versus sternal wires: one study (Negri 2002)
Criss-cross sternal wires versus standard trans-sternal closure: one study (Bottio 2003)

Characteristics of studies included in the Health Economic review (Appendix
D17)
Fifteen studies were included in the health economics review (Angelini 1984, Brasel 1997, Brolin 1996,
Chugtai 2000, Cohn 2000, Colombo 1997, Eldrup 1981, Ellis 1990, Gennari 2004, Israelsson 2000,
Maartense 2002, Matin 2003, Roolker 2002, Sebesta 2003, Shamiyeh 2001). Of these, ten studies
(Angelini 1984, Chugtai 2000, Cohn 2000, Colombo 1997, Eldrup 1981, Gennari 2004, Maartense
2002, Roolker 2002, Sebesta 2003, Shamiyeh 2001) were also identified in the clinical review.
However, after discussion with the GDG, Roolker 2002 was excluded from the analysis as zippers are
not used in the UK. Five further studies were included (Brasel 1997, Brolin 1996, Ellis 1990,
Israelsson 2000, Matin 2003)

Brasel 1997 used a decision tree model populated with data derived from a systematic review of the
literature and meta-analysis to compare three different wound closure methods: primary closure;
delayed primary closure; and secondary closure of the wound. The population comprised a
hypothetical cohort of patients with contaminated wound due to perforated or gangrenous appendicitis.

Brolin 1996 was undertaken in the USA in patients undergoing gastric restrictive operations for morbid
obesity. The study was based on a quasi experimental design and compared midline closure of the
linea alba using non-absorbable sutures (#1 Ethibond) placed in a continuous fashion with absorbable
sutures (#1 PDS) placed using an interrupted figure-eight technique.

Ellis 1990 was undertaken in Canada in patients undergoing facial plastic and reconstructive surgery.
The study was based on a retrospective cohort study comparing N-butyl-2-cyanoacrylate with fibrin
glue. Matin 2003 was undertaken in the USA in patients undergoing elective laparoscopic surgery and
compared octylcyanoacrylate adhesive with suturing, and was based on a quasi-randomised trial.
Finally, Israelsson 2000 was undertaken in Sweden and compared two different methods of
continuous suturing, one where the suture length: to wound length (SL:WL) ratio was less than four,
and another one where the SL:WL ratio was greater or equal to four, in patients operated though a
midline laparatomy incision. in patients undergoing laparatomy incision. The study was based on a
cohort study with historical controls.

Methodological quality of included clinical studies (Appendix E17)
In four studies, wounds rather than people were randomised and it was unclear if this had been
accounted for in any of the analyses (Cahill 1989, Leaper 1985a, Murphy 1995, Anatol 1997).

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The method of randomisation was reported in 21 studies, of which 19 were classified as adequate
(Anatol 1997; Arroyo 2001; Bhatia 2002; Colombo 1997; Harvey 1986; Jallali 2004, Krukowski 1987,
Leaper 1985b, Maartense 2002, Magann 2002; Niggebrugge 1999; Ong 2002, Orr 1990; Osther 1995,
Ozturan 2001, Rink 2000; Shamiyeh 2001, Velhamos 2002; Wolterbeek 2002). Two studies had
inadequate randomisation (Hsiao 2000, McNeill 1986 both used hospital numbers for allocation), but
for many comparisons quasi-randomised studies were not included because there were a large
number of studies with true randomisation. The rest did not state the method of randomisation or were
unclear (Keng 2002).

Allocation concealment was reported in 16 studies, of which an adequate or partially adequate method
was described in 14 (Beresford 1993, Cameron 1987, Carlson 1995, Farnell 1986, Jallali 2004,
Korenkov 2002, Maartense 2002, Magann 2002, Mylonas 1991, Ong 2002, Sahlin 1993, van den
Ende 2004, Wetter 1991, Wolterbeek 2002). Two studies reported inadequate allocation concealment
(Hsiao 2000, McNeill 1986).

There was an attempt at blinding of the outcome assesssor in 19 studies (Angelini 1984, Angelini
1985, Cameron 1987, Colombo 1997, Farnell 1986, Gislason 1995, Gennari 2004, Greene 1999,
Hsiao 2000, Krukowski 1987, Maartense 2002, Ong 2002, Ozturan 2001, Ranaboldo 1992, Sadick
1994, Sahlin 1993, Shamiyeh 2001, Sinha 2001, Toriumi 1998,). In 14 (Beresford 1993, Bhatia 2002,
Chughtai 2000, Cohn 2001, Eldrup 1981, Gainant 1989, Harvey 1986, Johnson 1997, Korenkov 2002,
Magaan 2002, Murphy 2004, Risnes 2002a, Risnes 2002b, van den Ende 2004) the outcome
assessors were not blinded, and in the rest blinding was not stated.

There were no withdrawals in 16 studies (Bhatia 2002, Chowdhury 1993, Corder 1991, Gainant 1989,
Greene 1999, Maartense 2002, McNeill 1986, Mylonas 1991, Murphy 1995, Nasir 2001, Niggebrugge
1999, Orr 1990, Ozturan 2001, Risnes 2002a, Risnes 2002b, Wetter 1991). Two studies had more
than 20% loss to follow up (Magann 2002, 22-32% across groups and Rink 2000 had 52% in the
retention group). Only three studies (Bhatia 2002, Korenkov 2002 and Wolterbeek 2002) stated they
carried out intention to treat analyses.

Comparability of the groups at study entry was usually demonstrated, but one study (Fagniez 1985
had a significant difference (p<0.001) between groups in the number receiving antibiotics. The
Karabay 2005 study showed an almost significant difference in the number of patients with diabetes in
the two groups. Nine studies (Cohn 2001, Fagniez 1985, Farnell 1986, Johnson 1987, Magann 2002,
Niggebrugge 1999, Risnes 2002a, Risnes 2002b, van den Ende 2004) reported an a-priori sample
size power calculation, but despite this, the Cohn study did not recruit sufficient people.

The risk of bias was assessed for each included study and it was decided that the Rink 2000 and
Fagniez 1985 studies presented a high risk and the Hsiao 2000 and McNeill studies presented a
medium risk. Therefore these studies were examined in a sensitivity analysis.
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Methodological quality of health economic studies (Appendix E17)
Overall the costing analysis of the studies included in the health economics review tended to be very
limited, with the majority of studies only including the costs associated with time to wound closure and
the costs of the wound closure consumables. Such limited costing studies reduce the validity of the
results, as these studies will not identify all the true costs associated with the particular wound closure
intervention under study.

In addition, three studies (Angelini 1984, Brolin 1996, Colombo 1997) compared two different
techniques of suturing while comparing two different suturing materials at the same time. Therefore, it
is not possible to determine from these studies if potential differences in costs or outcomes between
the two groups were due to the technique, material used, or a combination of both.

Only three studies (Brasel 1997, Cohn 2003, Israelsson 2000) undertook comprehensive cost
analyses by including hospitalisation costs and treatment costs. One study (Israelsson 2000) also
included social care costs incurred during patients sickness absence from work. However, despite
undertaking comprehensive cost analysis, the costing methods used in one study (Cohn 2003) were
not clear. For example, it remained unclear how the authors described significant cost differences, as
they did not report any p-values and differences between the two groups appeared to be large, and
which cost categories were included under hospital charges.

Furthermore, Brasel 1997 was the only study which used Quality Adjusted Life Years (QALYs) as
measure of health outcome. Utility scores for health states were derived from authors assumptions,
but were varied, along with other model parameters, in sensitivity analyses.

Results
The characteristics of studies section reports that a number of comparisons changed more than one
variable at a time. For these studies, it is impossible to decide which change had an effect on the rate
of SSI. Therefore the only comparisons possible are in the form of package 1 versus package 2,
which may be useful, but are not necessarily generalisable.

All studies reported wound infection, but some studies had too short a follow up period; the the GDG
excluded from the SSI analyses all studies with a follow up time of less than seven days. This meant
that Angelini 1984 and Angelini 1985 were not included in the analysis for SSI rates.

The GDG discussed the evidence and concluded that the choice of methods of closure should be
made in the light of all factors (e.g. also taking into account cosmetic appearance, ease of use, etc).
Their view was that it was difficult to make recommendations based on the rates of SSI in isolation.
They therefore decided to recommend approaches that would be expected to reduce SSI, but to make
it clear that the final choice of method of closure should take into account all relevant factors.
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A) Skin Closure

Non-absorbable sutures versus absorbable sutures
Six studies compared a non-absorbable synthetic suture with an absorbable synthetic suture.
Generally, differences in the suture technique, material and study methodology precluded pooling
studies, but some subgroup analyses have been included (Figure 1). Where two variables were
changed across groups this is indicated on the forest plot by [2V].

Rate of SSI
All studies reported the incidence of wound infection. In three, infection was defined as the presence of
discharge (Corder 1991, Karabay 2005, Leaper 1985a) and in three bacteriological confirmation was
required (Angelini 1984, Angelini 1985, Murphy 1995). In two studies wound infection was measured
at up to 5 days (Angelini 1984, Angelini 1985), one at up to 2 weeks (Murphy 1995), and two at up to 6
weeks (Corder 1991, Leaper 1985a). The GDG later excluded the two Angelini studies from the
analysis because the follow up time was too short.

In most studies, the incidence of SSI was low and the confidence intervals were wide so that
differences between one suture and another were not detected (Figure 3). The exception was that two
studies (Corder 1991, Karabay 2005) separately found statistically significantly fewer SSIs for
interrupted mattress monofilament non-absorbable sutures than for subcuticular multifilament
absorbable sutures. However, as noted above, these studies changed more than one variable at a
time, so the only comparisons were of combination 1 versus combination 2 (see also comparison of
subcuticular and interrupted mattress techniques below). It was concluded that there was insufficient
evidence to determine if there is a difference between absorbable and non-absorbable sutures or
between monofilament and multifilament.














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1 Figure 3: non-absorbable suture versus absorbable suture rate of SSI (NB scale 0.01 to 100)
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Cost-effectiveness
One study compared the cost effectiveness of non-absorbable (monofilament) versus absorbable
(multifilament) sutures (Angelini 1984). However, this study compared two different variables (i.e.
suture material and technique of closure) at the same time. Therefore it is not clear from which of
these variables were responsible for the differences in outcomes and costs.

Angelini 1984 found that suturing the wound with non-absorbable sutures was found to be faster than
with absorbable sutures (144 vs. 264 seconds, respectively), and incurred less consumable costs per
10cm of wound length (0.15 vs. 0.72; respectively).

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Suturing technique 1 versus suture technique 2

Continuous versus interrupted suture

Primary outcome rate of SSI
One study (Murphy 1995) randomised wounds to continuous nylon and interrupted nylon suture
techniques for closing the skin. The confidence interval was too wide to draw conclusions from this
study (Figure 2).







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1 Figure 2 Post-operative wound infection: continuous versus interrupted technique rate of SSI
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Subcuticular versus interrupted mattress suture

Six studies compared subcuticular and interrupted mattress sutures, five of which simultaneously
varied whether the sutures were absorbable or non-absorbable; different materials were also used.
i) Subcuticular absorbable versus interrupted mattress non absorbable sutures

Primary outcome - rate of SSI (up to six weeks)
Although the studies used different suture materials, and two (Risnes 2001 and 2002a) had infection
measured up to 6 weeks, the studies were combined in a meta-analysis (Figure 3).
There were statistically significantly more SSIs for the subcuticular technique using absorbable sutures
compared with the interrupted mattress (percutaneous) technique using non-absorbable sutures
(Figure 3); RR 2.17 (95%CI 1.46, 3.21); number needed to treat 10.

Figure 3: Subcuticular absorbable versus interrupted mattress non absorbable rate of SSI
(NB scale is 0.01 to 100)
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Cost effectiveness
No economic evaluation was found comparing the cost-effectiveness of subcuticular suturing
technique with absorbable sutures and non-absorbable monofilament sutures placed using an
interrupted mattress technique.

However, the clinical review found there were statistically significantly more SSIs for the subcuticular
technique using absorbable sutures compared with the interrupted mattress (percutaneous) technique
using non-absorbable sutures. Taking into account that the average cost of treating an SSI is 3,313,
the subcuticular suturing technique with absorbable sutures would not appear to be cost-effective
when compared to non-absorbable monofilament sutures placed using an interrupted mattress
technique.

ii) Subcuticular non-absorbable versus interrupted mattress non-absorbable sutures
One study (Onwuanyi 1990) compared subcuticular nylon with transdermal interrupted sutures
after appendectomy.

Primary outcome rate of SSI
There was too much uncertainty (wide confidence interval) to determine if there is a difference in rates
of SSI between the two interventions {Figure 4); OR 1.00 (95%CI 0.19, 5.21).

Figure 4: Transdermal interrupted versus subcuticular continuous rate of SSI
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Secondary outcomes
No wound abscesses occurred in either group. Persistent pain at 6 months was present in 2/42
patients with the interrupted suture, versus 0/44 with continuous suture.

iii) Subcuticular non-absorbable versus vertical mattress absorbable sutures

Primary outcome Rate of SSI
Two studies (Angelini 1984 and Angelini 1985) compared non-absorbable subcuticular suturing with
closure using vertical mattess absorbable sutures in patients having CABG and open heart surgery.
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Both studies reported the incidence of infections at only five days. The GDG excluded this outcome
from the analysis because the follow up time was too short.

Secondary outcomes
These studies also reported wound dehiscence rates at 10 days and cosmetic appearance at 45 days.
Meta-analysis for the former showed a statistically significant difference favouring subcuticular sutures;
OR 0.14 (95%CI 0.02, 0.79), Figure 5. The latter showed a statistically significant difference in the
number of patients assessed as having an excellent cosmetic appearance, favouring subcuticular; RR:
2.39 (95%CI 1.71, 3.36); Figure 6.

Figure 5: Subcuticular non-absorbable versus vertical mattress absorbable sutures wound
dehiscence at 10 days
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Figure 6: Subcuticular non-absorbable versus vertical mattress absorbable sutures cosmetic
appearance rated as excellent by patients
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Cost-effectiveness
One study compared the cost effectiveness of non-absorbable subcuticular suturing with closure using
vertical mattress absorbable sutures (Angelini 1984).

Angelini 1984 found that suturing non-absorbable subcuticular suturing was found to be faster than
closure using vertical mattress absorbable sutures (144 vs. 264 seconds, respectively), and incurred
less consumable costs per 10cm of wound length (0.15 vs. 0.72; respectively).

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Taking into account the results from the clinical review, which found that non-absorbable subcuticular
suturing was more effective in terms of wound dehiscence and cosmetic appearance as rated by
patients, the use of such sutures is highly likely to be cost-effective when compared to vertical
mattress absorbable sutures.

Bilayer versus vertical mattress sutures

Primary outcome - Infection
Sadick reported 3/50 in patients having excision of benign pigmented lesions on the back whose
wounds were closed with the bilayer method, compared with 2/50 for the vertical mattress sutures
(OR: 1.53 (95%CI 0.24, 9.59), i.e., too much uncertainty to draw conclusions).

Secondary outcomes
Wound dehiscence occurred in 3/50 versus 1/50. Hypertrophic or keloid scars formed in 8/50 with the
bilayer method, compared with 1/50 for the mattress sutures, p<0.031.

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Non-suture versus suture closure material

Staples versus skin sutures

Twelve studies (13 comparisons), involving a total of 1174 patients, assessed the difference between
staples and sutures for the skin (Figure 7). The two comparisons within the Angelini 1984 study were
combined by summing the results in the two sutures arms. Four studies involved more than 100
participants (Chughtai 2000, Eldrup 1981, Johnson 1997, Wolterbeek 2002). Two studies (Johnson
1997 and Harvey 1986 were analysed separately because they had within patient randomisation, and
there would have been unit of analysis errors if all studies were combined. All of the studies assessed
wound infection; two studies (Grgi 2002, Murphy 2004) also assessed wound dehiscence.

Primary outcome rate of SSI
There was very little difference between the two groups and apparently no heterogeneity amongst
studies; Peto OR: 0.81 (95%CI 0.46, 1.40). The Grgi 2002 study found no infections in either group.

Secondary outcomes
The Murphy 2004 study also examined wound dehiscence: it found one episode of dehiscence in each
arm (n=31 with staples versus 29 with sutures). The Grgi 2002 study found no dehiscence in either
group. Neither trial is insufficiently powered to detect a difference between the groups for this outcome.




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1 Figure 7: Staples versus sutures rate of SSI
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Cost-effectiveness
Three studies (Angelini 1984, Chughtai 2000, Eldrup 1981) compared the cost-effectiveness of using
staples with sutures for closing wounds. These three studies found that the consumable costs of
wound closure using staples were substantially higher than for sutures.

None of these studies included the staff time costs associated with wound closure.
Two studies (Angelini 1984, Eldrup 1981) found that duration of wound closure was faster when
stapling than when suturing. However, absorbable sutures (Angelini 1984, Chughtai 2000) do not
require removal by a healthcare professional, and therefore, overall, there could be potential cost
savings associated with using absorbable sutures compared to staples.

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Tissue adhesive versus suture

Primary outcome rate of SSI
Eight studies reported wound infection as an outcome, but this was measured at varying times and
there were different definitions of infection. Cheng 1997 noted infection at day 1, 2, 3, 7 and 30,
defined as wound discharge with positive bacterial culture. Keng 1989 defined infection as the
presence of pus and examined wounds at 1 and 4 weeks. Ozturan 2001 defined infection as an
abscess requiring drainage and examined wounds at 1 week. Maartense 2002 defined infection as
spontaneous drainage from a wound or a wound requiring surgical drainage of purulent fluid and noted
this at 2 weeks and 3 months. The remaining studies reported infection as an outcome but did not
describe how it was measured.

The studies were analysed as two subgroups according to the particular cyanoacrylate (butyl and
octyl), and the results were also pooled overall. This pooling within subgroups was carried out despite
differences in comparator. There was insufficient evidence (wide CI) to determine if there is a
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difference in the rate of SSI between individual adhesives and sutures (Figure 8); Peto OR= 1.45
(95%CI: 0.56 to 3.79).

Figure 8: Tissue adhesives versus sutures - Rate of SSI
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Secondary outcomes

Wound dehiscence
There were data from eight trials that reported the rate of dehiscence (Gennari 2004; Greene 1999;
Ong 2002; Ozturan 2001; Shamiyeh 2001; Sinha 2001; Toriumi 1998; van den Ende 2004).

Figure 9: Tissue adhesive versus sutures - wound dehiscence
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A statistically significant difference was detected between the proportion of wounds with dehiscence
for butylcyanoacrylate on its own Peto OR 6.15 (95%CI: 2.30, 16.41), although there was some
heterogeneity (I
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statistically significant Peto OR 6.21 (95%CI: 2.40, 16.11), and the heterogeneity was much less
(I
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=7%).

Cosmetic appearance
Ten studies (Cheng 1997, Gennari 2004, Greene 1999, Keng 1989, Maartense 2002, Ong 2002,
Ozturan 2001, Sinha 2001, Toriumi 1998, Van den Ende 2004) reported cosmetic appearance as an
outcome, but only two reported useable data (Maartense 2002, Ozturan 2001). In one study
(Maartense 2002) patients were asked to score their own cosmetic result using a validated visual
analogue scale. Surgical residents who were blind to the wound closure method also scored the
cosmetic appearance using a visual analogue scale and the Hollander Wound Evaluation Score.
These assessments were undertaken at 3 months. In the second study, Ozturan 2001 reported
cosmetic appearance at three months by blinded assessment of photographs using VAS, with best
possible scar as 100 and worst possible scar as 0, and also used the Hollander scale. Results were
given for two assessing surgeons, but those of surgeon A were selected for the meta-analysis.

There were no statistically significant differences detected for either the patients' assessments of
cosmetic appearance (Maartense 2002), mean difference -2.0 (95%CI 10.3, 6.3) on a visual analogue
scale of 0 to 100 (Figure 10), or the surgeons' assessments of cosmetic appearance (Figure 11).


Figure 10: Cosmetic appearance assessed by the patient (VAS 0 to100)
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Figure 11: Cosmetic appearance assessed by the surgeon (scale 0 to 100)
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Patient satisfaction
Patient satisfaction interviews in one study (Greene 1999) included questions about comfort, pulling
sensation, and appreciation of lack of suture removal at week 1, 2 and 4. Wound comfort at one and
four weeks was assessed in another study (Keng 1989). A third study assessed patients at 1 year
using a scale of satisfaction with scar (Shamiyeh 2001). A fourth study (Ong,2002) reported patient
satisfaction on a 100mm VAS scale, but there was no significant difference between groups. In one
further study (Greene 1999) out of 20 patients, 13 preferred glue and seven sutures. There was no
significant difference in patient satisfaction.

Figure 12: Patient satisfaction
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Cost-effectiveness evidence
Five studies compared wound closure using tissue adhesives with suturing. Only one study (Sebesta
2003) found that the duration of time needed to close the wounds was shorter using sutures than with
tissue adhesives, although the difference was not statistically significant. The other four studies
(Gennari 2004; Maartense 2002; Matin 2003; Shamiyeh 2001) all found that the duration of time was
substantially lower when closing wounds using tissue adhesives, with all four finding this difference to
be statistically significant. In terms of costs of the intervention, of the four studies (Gennari 2004;
Maartense 2002; Matin 2003; Sebesta 2003) that included both the costs of consumables used in
wound closure and the time costs associated with wound closure, three (Gennari 2004; Maartense
2002; Matin 2003) found that substantial cost savings were generated when wounds were closed
using tissue adhesives rather than suturing, with only one study (Sebesta 2003) finding higher costs
when using tissue adhesives than suturing.

However, as demonstrated in the clinical review, tissue adhesives were associated with a significant
increase in wound dehiscence. As a result, it is unclear if wound closure using tissue adhesives is
cost-effective when compared to suturing.

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Tissue adhesive absorbent dressing (Op-site) versus suture
Two studies (Angelini 1984, Angelini 1985) compared a tissue adhesive dressing with sutures. In each
study, the suture arms were combined to give a single comparison.

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Primary outcome rate of SSI
This study was not analysed for the outcome of SSI rate because the follow up time was too short (5
days) for both of these studies.

Secondary outcomes

Wound dehiscence
There was insufficient information to determine if there is a difference between a tissue adhesive
dressing and sutures.

Figure 13: tissue adhesive dressing versus suture wound dehiscence
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Cost-effectiveness evidence
One study (Angelini 1984) found that the average time needed to close 10cm of skin with tissue
adhesive dressings (36sec) was lower than when using nylon suture (144sec) or subcuticular suture
(264sec). Closing 10cm of wound with nylon suture incurred less costs (0.15) than when using tissue
adhesive dressings (0.63) or subcuticular suture (0.72). However, as the costing study did not
include the time costs associated with wound closure, the full cost of each intervention is unclear.

Taking into account the effectiveness evidence presented above, which found insufficient clinical
evidence for the rate of SSI, there is insufficient information to determine if tissue adhesive dressings
are cost-effective when compared to nylon or subcuticular sutures for wound closure.

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Non-suture closure material 1 versus non-suture closure material 2

Tissue adhesive versus adhesive tape

Primary outcome rate of SSI
There was insufficient evidence (wide CI) to determine if there is a difference between tissue adhesive
and tape in the rate of SSI.




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1 Figure 14: Tissue adhesive versus adhesive tape rate of SSI
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Secondary outcomes

Wound dehiscence
There was insufficient evidence (very wide CI) to draw conclusions in a single trial (Shamiyeh 2001)
for dehiscence; OR=0.96 (95%CI: 0.06 to 16.23).

Cosmetic outcome
There was no significant difference between adhesive and tape in one study (Maartense 2002) for
patients' assessment of cosmetic appearance (although the confidence interval was fairly wide),
however there was a statistically significant difference for the surgeons' assessment, with a mean
higher rating for the tissue adhesive group in one study; mean difference 13 (95%CI 5, 21).

Figure 15: Cosmetic appearance assessed by patient (VAS 0 to 100)
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Figure 16: Cosmetic appearance assessed by surgeon (0 to 100)
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Patient satisfaction
There were no statistically significant differences for patient satisfaction.

Figure 17: tissue adhesive versus tape patient satisfaction
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Cost-effectiveness evidence
Two studies compared wound closure using tissue adhesives with adhesive tape (Maartense 2002;
Shamiyeh 2001). These two studies found that duration of wound closure was substantially faster with
adhesive tape than with tissue adhesives, with one study finding this difference to be statistically
significant (Maartense 2002). Both studies also found that closing wounds with adhesive tape was less
costly than with OCA tissue adhesives.

Taking into account the effectiveness evidence presented above, it would appear that the use of tissue
adhesives was not cost-effective when compared to adhesive tape.

Adhesive 1 versus adhesive 2

There was no clinical study complying with the inclusion criteria of the review that compared one tissue
adhesive with another.

Cost-effectiveness evidence
One retrospective cohort study (Ellis 1990) compared two different types of adhesives for wound
closure. The authors found no evidence of wound infection in either group, although found better
wound healing in the n-butyl-2-cyanoacrylate group, and found that use of n-butyl-2-cyanoacrylate was
less costly than fibrin glue. However, caution should be taken when interpreting the results from this
study, as their main unit of outcome appeared to be subjective, and the study was performed during
different time periods, therefore, other external factors other than the interventions could have affected
the authors results.

Tissue adhesive dressing (Op-site) versus staples

One study (Angelini 1984) compared a tissue adhesive dressing with staples.
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Primary outcome rate of SSI
There was insufficient information to determine if there is a difference between the tissue adhesive
dressing, Opsite and staples because the follow up time was too short.

Secondary outcome wound dehiscence
There was insufficient information (wide confidence interval) to determine if there is a difference
between groups.

Cost-effectiveness evidence
One study (Angelini 1984) found that the average time needed to close 10cm of skin with tissue
adhesive dressings (36sec) was lower than when using staples (72sec). Closing 10cm of wound with
tissue adhesive dressings (0.63) was less costly than when using staples (3.60). Therefore, the
including both staff and consumable costs, use of tissue adhesives dressings for wound closure would
generate cost savings when compared to staples.

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Timing of closure 1 versus timing 2

Delayed versus primary suture

Primary outcome - Infection
Five studies, involving a total of 336 patients, assessed wound infection in groups of patients treated
with delayed or primary skin closure. These were generally patients undergoing dirty procedures,
where the risk of infection is high, and it is suggested that leaving the skin open can help prevent
wound infection in such cases. Different types of primary closure were used: staples (Cohn 2001,
Velmahos 2002), silk sutures (Hiramatsu 1996, Maffuli 1991) and prolene sutures (Khammash 1994).
The delayed closure differed too: two studies did not close the wound and packed it with a dressing
(Cohn 2001, Velmahos 2002), one bandaged the open wound (Maffuli 1991), one treated with
absorbent towels (Hiramatsu 1996) and the other had loose prolene sutures plus gauze (Khammash
1994). The Hiramatsu study used a povidone iodine gel before closure in the primary closure arm and
is therefore considered to be confounded. There was significant heterogeneity (I
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=81%) amongst the
studies, which is especially noticeable in view of the wide CIs the Cohn study suggested a significant
benefit of delayed skin closure, while Hiramatsu found the opposite, i.e. a significantly higher rate of
infection where closure was delayed. As mentioned above, the Hiramatsu study was probably
confounded by the use of PI gel and the Khammash study compared loose sutures with tightened
sutures so this may not be the same comparison as closed versus open. A sensitivity analysis (Figure
18.2) in the absence of these studies found statistically significantly fewer infections for the delayed
group; OR 0.22 (95%CI 0.09, 0.51) and no heterogeneity. The GDG did not feel sufficiently confident
in this sensitivity analysis to draw conclusions.

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1 Figure 18: delayed versus primary closure rate of SSI and wound dehiscence
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Secondary outcomes
Velmahos reported wound dehiscence in 3/22 patients in the delayed group versus 8/26 with primary
closure (OR 0.36 (95%CI 0.08, 1.55); i.e. wide confidence interval; necrosis in 2/22 versus 1/26 and a
mean hospital stay of 18 versus 17 days. There was insufficient evidence to determine if there was a
difference between the groups.

Cost-effectiveness
Two studies (Brasel 1997, Cohn 2000) compared the cost-effectiveness of primary closure and
delayed primary closure of the surgical wound. Brasel 1997, also assessed the costs and outcomes
associated with secondary wound closure. The results from a decision analytic model (Brasel 1997)
found that primary closure was both more effective, in terms of QALYs gained, and less expensive
than delayed primary closure. In contrast (Cohn 2001) concluded that delayed primary closure was a
cost-effective intervention as it significantly reduced wound infections, with no significant increase in
hospital costs. However, the costing methods used in this study are not clear and it is unclear how the
authors judged significant differences in costs as no p-values were reported.

Brasel 1997 also found that secondary closure of the surgical wound was not cost-effective when
compared to either primary closure or delayed primary closure.

B) Closure of internal layers

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Suture material 1 versus suture material 2

Non-absorbable sutures versus absorbable sutures: Seven studies compared a non-absorbable
synthetic suture with an absorbable synthetic suture. Generally, differences in the suture technique,
material and study methodology precluded pooling studies, but some subgroup analyses have been
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included (figure 19). The studies have been divided into those investigating closure of the abdominal
wall (Carlson 1995, Leaper 1985b, Cameron 1987, Krukowski 1987, Mylonas 1991, Orr 2003) and
those closing all layers (Gys 1989). Where two variables were changed across groups this is indicated
on the forest plot by [2V].

Primary outcome - Rate of SSI
All studies reported the incidence of SSI. In four, wound infection was not defined (Gys 1989, Leaper
1985b, Mylonas 1991, Orr 2003) in two infection was defined as the presence of discharge (Cameron
1987, Krukowski 1987) and in one bacteriological confirmation was required (Carlson 1995). In two
studies wound infection was measured in an undefined early postoperative period (Carlson 1995, Gys
1989), one was recorded at up to one month (Cameron 1987); three at up to 6 weeks (Krukowski
1987, Leaper 1985b (unclear), Orr 2003 (unclear)) and one did not state when the infections were
recorded (Mylonas 1991).

In most studies, the incidence of SSI was low and the confidence intervals were wide so that
differences between one suture and another were not detected. The exception was a meta-analysis of
two studies comparing polypropylene non-absorbable sutures with absorbable polydioxanone sutures
(each group with interrupted and monofilament sutures), which found a statistically significant
difference favouring absorbable polydioxanone, OR 2.02 (1.22, 3.34). Number needed to treat was
nine.

Figure 19 Rate of SSI; non-absorbable suture versus absorbable suture
Abdominal wall closure
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All layers
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Secondary outcome

Wound dehiscence
Seven studies (Cameron 1987, Carlson 1995, Gys 1989, Krukowski 1987, Leaper 1985b, Mylonas
1991, Orr 2003) reported the incidence of wound dehiscence in the post-operative period. Generally,
there were wide confidence intervals so that firm conclusions could not be drawn (Figure 20). There
was, however, statistically significantly less wound dehiscence for polydioxanone absorbable
monofilament sutures compared with polypropylene non-absorbable monofilament sutures for closing
the abdominal wall.

Figure 20 Post-operative wound dehiscence: non-absorbable suture versus absorbable suture
Abdominal wall
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21




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All layers closure

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Incisional hernia
Seven studies (Cameron 1987, Carlson 1995, Gys 1989, Krukowski 1987, Leaper 1985a, Leaper
1985b, Orr 2003) reported the incidence of incisional hernia at study endpoint. Again there were too
few events and participants to detect a significant difference in any study (Figure 21).

Mortality
The number of patients that died within the trial follow-up period was reported in four studies for all
treatment groups combined and was not reported separately for each treatment group.

Figure 21: Post-operative incisional hernia: non-absorbable suture versus an absorbable
suture
Abdominal wall
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23





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Cost-effectiveness
One study compared the cost effectiveness of non-absorbable suturing placed using an interrupted
technique versus absorbable suturing placed in a continuous fashion (Brolin 1996). However, this
study compared two different variables (i.e. suture material and technique of closure) at the same time.
Therefore it is not clear which of these variables were responsible for the differences in outcomes and
costs.

Brolin 1996 found that the time to wound closure was significantly faster using absorbable continuous
suturing than non-absorbable interrupted suturing (9.1min vs. 13.3min, respectively; p<0.001).
Although the authors found that the unit costs of absorbable sutures were higher than for non-
absorbable sutures ($4.63 vs. $1.76, respectively), once the costs associated with time required to
close the wound were included, the mean cost of suturing a patient was lower in the absorbable
continuous suture than the non-absorbable interrupted suture group ($4.18 vs. $11.09, respectively).

Comparison of different types of non-absorbable sutures
One study (Cahill 1989) compared three types of non-absorbable suture, nylon, polybutester and
polytetrafluoroethylene (PTFE) in 171 patients undergoing inguinal hernia repairs, using a darn
technique. Significantly more patients in the PTFE group compared with both other groups developed
deep-seated wound infections up to 1 month with prolonged discharge of pus, Peto OR 17.39 (95% CI:
2.21, 136.89), however, the confidence interval was extremely wide (Figure 22).

Figure 22; rate of SSI for PTFE sutures compared with nylon or polybutester sutures
26
27
28
29
Monofilament versus multifilament
Four studies (Colombo 1997, Hsiao 2000, Osther 1995, Sahlin 1993) compared a synthetic
absorbable monofilament suture with a synthetic absorbable multifilament suture. However, in three
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cases (Colombo 1997, Osther 1995 and Sahlin 1993) three variables were changed at once, and the
Sahlin study measured wound infection at one year only (i.e. not SSI). The Hsiao study (which
changed two variables) was also quasi-randomised. It was therefore not possible to assess the effect
of either suture material or filament type, and only comparisons of the type combination 1 versus
combination 2 were possible.
Primary outcome rate of SSI
One quasi-randomised study (Hsiao 2000) reported the incidence of wound infection at one month.
The OR for SSI rate was 0.64 (95% CI: 0.21, 1.96) for polydioxanone monofilament compared with
multifilament polyglactin 910. There was insufficient evidence (wide CI) to draw conclusions in this
single trial.


Figure 23: Polydioxanone monofilament versus polyglactin multifilament rate of SSI
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17
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20
21
Secondary outcomes
Incisional hernia
The OR estimate for incisional hernia at two years for the Hsiao study was 0.50 (95% CI: 0.13, 1.95)
for polydioxanone monofilament versus polyglactin multifilament (Figure 24). The other comparisons
are not reported here because of the multiple changes in variables.

Figure 24: Post-operative incisional hernia
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Mortality
Two studies reported mortality rates. In the study by Hsiao, 14/184 (7.6%) died in the polyglactin 910
group and 9/156 (5.8%) in the polydioxanone group. The cause of death was advanced malignancy in
17/23 (73.9%) and liver cirrhosis with oesophageal varices in 5/23 (26.1%), i.e. not related to SSI. The
mortality rate in the study by Osther was 20/100 (20%), and 28/104 (27%) at one year or more follow-
up. Cause of death was not reported.

Cost-effectiveness
Only one study compared the cost effectiveness of alternative absorbable sutures (Colombo
1997).They compared the costs and effects of using polyglyconate (monofilament) suture and
interrupted polyglycolic acid (multifilament) suture. However, as the authors compared two different
variables (i.e. suture material and technique of closure) at the same time it is not possible to determine
the cost effectiveness between these absorbable suture types.

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Suture technique 1 versus suture technique 2

Continuous versus interrupted suture

Four studies assessed the method of closing the internal tissue layers with either continuous or
interrupted sutures. Three of these reported outcomes of SSI rate, four reported wound dehiscence
and three hernia. The Colombo study was not analysed with the others because it changed several
variables at once.

Primary outcome rate of SSI
There was little difference in the rate of SSI, although the interrupted method was favoured; OR: 1.21
(95%CI 0.92, 1.60). However, the Fagniez study showed a major difference in an important
confounding factor (the use of antibiotics) between the two groups (more in the interrupted group
p<0.001). It is not stated who was given antibiotics, and it was not clear if these were given before or
after evidence of infection. Without Fagniez, the remaining study had a wide confidence interval. We
conclude there is little difference between the continuous and interrupted suture techniques, but there
is uncertainty in this statement.









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1 Figure 25: continuous versus interrupted technique rate of SSI
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Secondary outcomes

Wound dehiscence
There was insufficient information (wide confidence interval) to determine if there was a difference in
the rate of wound dehiscence.

Hernia incidence
There was insufficient information (wide confidence interval) to determine if there was a difference in
the incidence of hernia.

Cost-effectiveness
Two studies (Brolin 1996, Colombo 1997) assessed the cost and outcomes of closing the internal
tissue layers with either continuous or interrupted sutures. Results from these two studies showed that
suturing surgical wounds in a continuous fashion reduced the costs of wound closure consumables
and the staff time required close the wound when compared to suturing in an interrupted fashion.
However, both these studies compared different suture materials at the same time making it difficult to
judge if differences in costs and outcomes between the two patient groups were due to the technique,
material used, or a combination of both.

Continuous loop versus continuous mass closure

Primary outcome rate of SSI
One study (Nasir 2001) compared continuous loop with continuous mass closure in patients having a
laparotomy. There was insufficient information to determine if there is a difference between the two
methods (wide CI).

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1 Figure 26: Continuous loop versus mass closure rate of SSI
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Continuous loop versus continuous running suture

Primary outcome infection
One study compared closure using continuous loop with a continuous running suture (Niggebrugge
1999). There was insufficient information to decide if there was a difference in the two methods: OR
0.70 (95%CI 0.35, 1.40).

Secondary outcomes
There was too much uncertainty to determine if there was a difference in wound dehiscence, but there
were significantly more patients experiencing severe wound pain (7 on 0-10 scale) at two days in the
continuous running suture group.

Figure 27: continuous running versus continuous loop
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Other closure comparisons

Comparison of two ratios of suture length: wound length

There were no clinical effectiveness studies reporting differences in the ratio of suture length to wound
length.

Cost-effectiveness
Israelsson 2000 (a cohort study with historical controls) found that the number of patients requiring a
hernia repair was greater in the group with a suture length to wound length (SL:WL) ratio < 4 than in
those with a ratio > 4 (3.1% vs. 1.5%). The authors found, that after including hospital costs and the
costs associated with sick-leave, the intervention (SL:WL ratio >
11
4) generated savings of SEK116 per
patient, which extrapolated to the whole of Sweden, yielded annual savings of SEK2,107,140.
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Types of internal tissue closure

Mesh versus suture

Primary outcome infection
Two studies examined mesh versus suture for simple hernias. Sutures were not considered a suitable
form of treatment for complex hernias. There was too much uncertainty to decide if there was a
difference between the groups (heterogeneity I
2
=55% and wide CI).

Figure 28: mesh versus suture rate of SSI
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31
32
33

Secondary outcomes
The rate of recurrence of hernias was reduced by the mesh, compared to sutures, but again there was
heterogeneity.
No deaths were reported in either of these studies.



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1 Figure 29: mesh versus suture hernia recurrence
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Mesh versus skin graft

Primary outcome infection
One (Korenkov) of the two studies that assessed mesh versus sutures (above) also had a third arm, in
which patients were treated with a skin graft. Data are available for comparisons between mesh and
skin graft for both simple and complex hernias, for wound infection and hernia recurrence. Neither of
these comparisons, nor that for all hernias, had sufficient information (wide CIs) to determine if there is
a difference between methods.

Secondary outcomes
There was insufficient information to determine if there was a difference between groups.

Figure 30: mesh versus skin graft rate of SSI
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18
19
20
21
22
23

Secondary outcomes
There was insufficient information to determine if there was a difference between groups in the rate of
recurrence.


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1 Figure 31: mesh versus skin graft rate of hernia recurrence
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Suture versus skin graft

Primary outcome infection
In the same Korenkov study, suture was compared with skin graft for simple hernias only (complex
hernias were not treated with suture). Infections occurred in 0/33 patients with suture and 2/28 with
skin graft.

Secondary outcomes
Hernias recurred in 4/33 patients with suture versus 4/28 patients with skin graft.

Open versus suture

Primary outcome rate of SSI
There was insufficient information to determine if there was a difference between groups.
One study (Magann 2002) examined subcutaneous closure with suture versus no closure, and showed
little difference in SSI rates; OR 0.80 (95%CI 0.38, 1.69); although the CI was fairly wide.

Figure 32: open versus suture rate of SSI
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Open versus drain

Primary outcome rate of SSI
The study described above (Magann 2002) also had a third arm examining the use of a subcutaneous
drain. There was insufficient information to determine if there was a difference between the open
group and the drain group; OR 0.69 (95%CI 0.32, 1.50).

Figure 33: open versus drain rate of SSI
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10
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16
Suture versus drain

Primary outcome rate of SSI
Data on SSI rates for the suture and drain groups can also be compared from the Magann study.
Again there was insufficient information; OR 0.86 (95%CI 0.41, 1.83).

Figure 34: suture versus drain rate of SSI
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Comparisons between an internal and an external intervention

Internal versus external mesh

One study (Gainant 1989) compared a polyamide fibre mesh applied externally to the skin, using a
topical glue, with a resorbable intraperitoneal mesh in 100 patients having gastro-intestinal surgery,
who were at high risk of wound dehiscence due to undernutrition, malignancy, ascites, peritoneal
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infection, immunodepression, abdominal irradiation, repetitive surgical interventions through the same
incision, or pulmonary disease.

Primary outcome rate of SSI
Wound infection was not measured in this study.

Secondary outcomes
Wound dehiscence was less in the patients treated with the internal mesh compared with the external
mesh (0/50 versus 8/50, OR 0.05 (95%CI 0.00, 0.88); p=0.04, with very wide confidence interval) of
which 5 were said to be due to infection, p<0.01). There was also a wide confidence interval for the
rate of abscess formation.

Figure 35: internal versus external mesh rate of dehiscence

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Primary closure versus subcutaneous catheter

Primary outcome rate of SSI
One study examined the rate of infections in patients undergoing abdominal operations in whom
primary skin closure was compared with subcutaneous catheter, either irrigated with saline, irrigated
with antibiotics, or not irrigated (Farnell). This was a large study (including a total of 3,282 patients),
and included a power calculation based on the overall infection rates.
The study found little difference in the rate of wound infection between primary skin closure and a
subcutaneous catheter (without irrigation).




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1 Figure 36: skin closure versus catheter rate of SSI
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6
There was also little difference between the catheter without irrigation and irrigation with either saline
or antibiotics, and the two types of irrigation also had very similar rates of SSI.

Figure 37: subcutaneous catheter with/without irrigation rate of SSI
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8
9
10
11
12
13

The authors also presented post hoc sub-group analyses, based on whether the wound was defined
as clean-contaminated (n=2,674), contaminated (n=404) or dirty (n=204), but this type of analysis is
not recommended because the patients were not randomised to interventions within these subgroups,
and particularly in the dirty subgroup any variations could be achieved by chance.

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Different methods of securing bones

Bone clips versus sternal wires

Primary outcome rate of SSI
One study (Negri) assessed sternal wound infection, dehiscence and death in patients having cardiac
surgery, whose sternums were closed using either thermoreactive Nitillium clips for bone
approximation (n=500) or standard closure with sternal wires (n=500). The Nitillium clips are thought to
be beneficial because they can be made pliable by low temperatures for insertion, then the shape is
restored on warming, to hold the bone together, but the device maintains some elasticity thereafter,
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which can reduce the stress on the bone if the patient coughs, for example, after operation. The rate of
SSI reported was:
Sternal wound infection: OR 0.80 (95%CI 0.38, 1.69), i.e., little difference between groups

Figure 38: bone clips versus sternal wires rate of SSI and dehiscence
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Secondary outcomes
Sternal wound dehiscence: OR 0.07 (95%CI 0.01, 0.54), i.e.statistically significantly better for clips, but
the confidence interval is wide.
Death occurred for 0/500 in the clips group compared with 1/500 (0.2%) in the sternal wires group.
The GDG decided not to draw conclusions based on dehiscence alone.
[GDG is this OK?}

Criss-cross sternal wires vs, standard trans-sternal closure

One study (Bottio 2003) assessed infections and deaths among 700 patients undergoing cardiac
operations through a median sternotomy.

Primary outcome rate of SSI
There were no SSIs in the group having double criss-cross wire closure versus 7 (2%) with standard
closure, this gave a statistically significant difference; Peto OR 0.13 (95%CI 0.03, 0.59).


Figure 38: bone criss cross wires versus standard closure rate of SSI
25
26 Deep sternal wound infection:
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There were no deep infections with criss-cross wires compared with six with standard closure, Peto
OR 0.13 (95%CI 0.03, 0.66).

Figure 39: bone criss cross wires versus standard closure rate of deep infection
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Evidence statements and recommendations 1
2
Level of
evidence
Evidence statements
1-

HE
For skin closure, there is insufficient evidence to determine if there is a difference
in the incidence of SSIs between absorbable and non-absorbable sutures.
There was weak evidence that non-absorbable sutures were faster to apply and
were associated with lower consumable costs than absorbable sutures.
1- For skin closure, there is insufficient evidence to determine if there is a difference
in the incidence of SSIs between continuous and interrupted, non-absorbable
sutures.
1-

For skin closure, there is insufficient evidence to determine if there is a difference
in the incidence of SSIs between monofilament and multifilament sutures.
1- For skin closure, there is insufficient evidence to determine if there is a difference
in the incidence of SSIs between subcuticular and interrupted mattress, non-
absorbable sutures.
1++




HE
For closure of the skin, there is good evidence to show that statistically
significantly more SSIs result when a subcuticular technique with multifilament
absorbable sutures is used, compared with an interrupted mattress
(percutaneous) technique using non-absorbable monofilament sutures.

Taking into account that the average cost of treating an SSI is 3,313, the
subcuticular suturing technique with absorbable sutures would not appear to be
cost-effective when compared to non-absorbable monofilament sutures placed
using an interrupted mattress technique.
1-



1+



1+



HE
For skin closure, there was insufficient evidence to determine if there is a
difference in the incidence of SSIs between subcuticular non-absorbable and
vertical mattress absorbable sutures, because the follow up time was too short.

However, in a meta-analysis of two studies there was a statistically significant
difference in the rate of wound dehiscence, favouring subcuticular non-
absorbable sutures.

There was a statistically significant difference in a meta-analysis of two studies in
the proportion of patients rating their wound appearance as excellent, favouring
subcuticular non-absorbable sutures.

There was fair evidence that subcuticular non-absorbable sutures were both
cheaper and faster to apply than vertical mattress absorbable sutures.
3
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1- For skin closure, there is insufficient evidence to determine if there is a difference
in the incidence of SSIs between bilayer and vertical mattress sutures.
1++

HE
There is good evidence from a meta-analysis of nine studies to show there is little
difference in the rate of infection between staples and sutures for skin closure.
There is evidence that sutures, both absorbable and non-absorbable, are
associated with lower consumable costs but take longer to administer than
staples.
1-



1+


1+




HE
For skin closure, there is insufficient evidence to determine if there is a difference
in the rate of SSI between individual tissue adhesives and sutures, or for the
comparison with both adhesives.

There is fair evidence to suggest that there is significantly more dehiscence in the
tissue adhesives group compared to sutures
.
There is fair evidence to suggest there is little difference in cosmetic outcomes
between tissue adhesives and sutures for skin closure. There was also no
significant difference in patient satisfaction in one study.

There was fair evidence that wound closure using tissue adhesives generated
cost savings when compared to sutures for skin closure. However, as tissue
adhesives were associated with a significant increase in wound dehiscence, it is
unclear if wound closure using tissue adhesives is cost-effective when compared
to suturing.
1-


1-



1+


HE
There is insufficient evidence to determine if there is a difference in rates of SSI
between tissue adhesive and tape for skin closure.

There is insufficient evidence to determine if the patients found the cosmetic
appearance to be satisfactory.

There is fair evidence to show that surgeons assessed the cosmetic appearance
and found it to be statistically significantly better in the tissue adhesive group.

Results from two randomised controlled trials indicated that wound closure with
adhesive tape generates cost savings when compared to tissue adhesives;
adhesive tape was found to be faster to apply and less costly than tissue
adhesives.
1-



There was insufficient information to determine if there is a difference in SSI rate
or the rate of dehiscence between the tissue adhesive dressing, Opsite, and
either sutures or staples for skin closure.

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HE There was limited evidence that use of tissue adhesive dressings for wound
closure generated cost savings when compared to staples.
1-




HE
There was too much uncertainty in a meta-analysis of five studies to determine if
there is a difference in the rate of infection between delayed and primary closure
of the skin. However, sensitivity analysis suggested statistically significantly fewer
infections were found when the wound was left open.

It is unclear from the health economics evidence whether primary closure is cost
effective compared to delayed primary closure. There is limited cost effectiveness
evidence that primary closure is more cost effective than secondary closure.
1+

For closure of the abdominal wall, there is good evidence that there are
statistically significantly fewer SSIs and significantly less dehiscence with
absorbable polydioxanone monofilament interrupted sutures compared with non-
absorbable polypropylene monofilament interrupted sutures.
1-



HE

For closure of the abdominal wall, there is insufficient evidence to determine if
there is a difference in the incidence of SSIs between absorbable monofilament
and absorbable multifilament sutures.

There was insufficient evidence to determine if absorbable monofilament sutures
were cost-effective when compared to multifilament sutures.
1- For closure of the abdominal wall, there is insufficient evidence to determine if
there is a difference in SSI rate when using non-absorbable continuous versus
non-absorbable interrupted nylon sutures
1-




HE

Suture techniques for closure of internal soft tissue layers:
A meta-analysis of two studies suggested little difference in the rate of SSI
between continuous and interrupted sutures. However, one of the studies was
probably confounded by the significant differential use of antibiotics.

There was weak evidence that placing sutures in a continuous fashion was faster
and associated with lower consumable costs than sutures placed using in an
interrupted fashion. However, these studies were confounded as different suture
materials were used.

1-





There was insufficient evidence in a single study to determine if there is a
difference in rates of infection between continuous loop and continuous mass
closure for closure of internal soft tissue layers.


1
2


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1-



1+

There was insufficient evidence to decide if there was a difference in infection rate
between continuous loop and continuous running sutures for closure of internal
soft tissue layers.

Significantly more patients experienced severe pain at two days in the latter
group.
HE There is limited evidence that having a suture length to suture wound length
greater than 4 is cost-effective for closure of internal soft tissue layers.

1-



1-



1-
Types of closure of internal layers
There was insufficient evidence in a meta-analysis of two studies to determine if
there is a difference in rates of infection between mesh and sutures for hernia
repair.

There was insufficient evidence in a single study to determine if there is a
difference in infection between mesh and skin graft for hernia repair.

In a single study, there was insufficient information to decide if there is a
difference in the rate of SSI between closure with sutures and either no closure or
a subcutaneous drain
1+ In a single study there was little difference in the rates of infection between
primary skin closure compared to subcutaneous catheter, regardless of the type
of irrigation used (or none).
1++


1+

There was good evidence in a single large study, to show little difference in SSI
rates between bone clips and sternal wires for securing bones.

There was fair evidence in a large study to show a statistically significant
difference in SSI rate, favouring criss cross wires over standard trans-sternal
closure.
1
2



Grade

Recommendations
A

D


Skin should be closed with either staples or a non-absorbable monofilament
suture using an interrupted percutaneous technique.
If there are extenuating clinical contraindications, or difficulties are anticipated in
the removal of either staples or sutures (such as in children), consideration should
be given to an alternative method of skin closure, for instance an absorbable
subcuticular suture.
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B

A
Tissue adhesives should be used with caution as they are associated with an
increased wound dehiscence rate.
The abdominal wall should be closed with an absorbable suture
1
2
3



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Appendix 1: suture materials (http://www.emedicine.com/ent/topic38.htm)

Absorbable sutures
Natural
Collagen: from the submucosa of sheep intestine or the serosa of beef intestine.
Surgical gut, plain: Tensile strength is maintained for 7-10 days postimplantation (variable with
individual patient characteristics). Absorption is complete within 70 days. This type of suture is
used for (1) repairing rapidly healing tissues that require minimal support, (2) ligating
superficial blood vessels, and (3) suturing subcutaneous fatty tissue.
Surgical gut, fast-absorbing: This type of suture is indicated for epidermal use (required only
for 5-7 d) and is not recommended for internal use.
Surgical gut, chromic (treated with chromium salt): Tensile strength is maintained for 10-14
days. The absorption rate is slowed by chromium salt (90 d). This type of suture may be used
in the presence of infection. Tissue reaction is due to the noncollagenous material present in
these sutures. Also, patient factors affect rates of absorption and make tensile strength
somewhat unpredictable.
Synthetic
Chemical polymers are absorbed by hydrolysis and cause a lesser degree of tissue reaction following
placement.
Polyglactin 910 (Vicryl): a braided multifilament suture coated with a copolymer of lactide and
glycolide (polyglactin 370). These sutures cause only minimal tissue reaction and may be
used in the presence of infection. Vicryl sutures are used in general soft tissue approximation
and vessel ligation.
Another similar suture material is made from polyglycolic acid coated with polycaprolate
(Dexon II).
Poliglecaprone 25 (Monocryl): a monofilament suture that is a copolymer of glycolide and E-
caprolactone. Poliglecaprone sutures are used for subcuticular closure and soft tissue
approximations and ligations.
Polydioxanone (PDS II): a polyester monofilament suture made of poly (p-dioxanone). This
suture provides extended wound support and elicits only a slight tissue reaction. PDS II suture
is used for soft tissue approximation, especially in pediatric, cardiovascular, gynecologic,
ophthalmic, plastic, and digestive (colonic) situations. Another similar suture material is made
from polytrimethylene carbonate (Maxon).
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Non-absorbable sutures
Natural
Surgical silk: made of raw silk spun by silkworms and may be coated with beeswax or silicone.
The problem with silk suture is the acute inflammatory reaction triggered by this material.
Surgical cotton: This is made of twisted, long, staple cotton fibers.
Surgical steel: This is made of stainless steel (iron-chromium-nickel-molybdenum alloy) as a
monofilament and twisted multifilament. Surgical steel suture is used primarily in orthopedic,
neurosurgical, and thoracic applications. This type of suture also may be used in abdominal
wall closure, sternum closure, and retention.
Synthetic
Nylon: a polyamide polymer suture material available in monofilament (Ethilon/Dermalon) and
braided (Nurolon/Surgilon) forms. The braided forms are coated with silicone.
Polybutester (Novofil): monofilament suture made of a copolymer of polyglycol terephthalate
and polytrimethylene terephthalate. Ideal for surface closure, permitting adequate tissue
approximation while allowing for tissue edema and detumescence.
Polyester fiber (Mersilene/Dacron [uncoated] and Ethibond/Ti-cron [coated]): This suture
material is formed from polyester, a polymer of polyethylene terephthalate. The multifilament
braided suture also comes coated with polybutilate (Ethibond) or silicone (Ti-cron). This suture
is commonly used for vessel anastomosis and the placement of prosthetic materials.
Polypropylene (Prolene): This monofilament suture is an isostatic crystalline stereoisomer of a
linear propylene polymer, permitting little or no saturation. The material does not adhere to
tissues and is useful as a pull-out suture (eg, subcuticular closure). This material is biologically
inert and elicits minimal tissue reaction. This material is useful in contaminated and infected
wounds, minimizing later sinus formation and suture extrusion.

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Introduction
This review looks at dressings for surgical site healing by primary intention, and their effects on the
prevention of SSIs. It is based on a Cochrane protocol (Sharp and McLaws. Wound dressings for
surgical sites, 2001), and summarises results of the studies identified by the authors of the protocol.
The review was updated by the NCC in January 2006.

Objectives
To determine the clinical and cost-effectiveness of various dressings for healing by primary intention in
the prevention of surgical site infections.

Criteria for considering studies for this review

Types of patient
Patients who had dressings applied in the operating theatre immediately after closure of the skin.

Types of comparison
The following types of comparison were investigated:
Dressing versus no dressing
Duration of dressing in place 1 versus duration 2
Type of dressing 1 versus type of dressing 2

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for both clinical
effectiveness studies and health economics reports for this review are given in Appendix C18.

Data extraction specific to this review
Details of the type of dressing. The British National Formulary has classified dressings into the
following groups (BNF 2005): alginate dressings; foam dressings; hydrogel dressings; hydrocolloid
dressings; vapour-permeable films and membranes; low adherence dressing and wound contact
materials; odour absorbent dressings; dressing packs; surgical absorbents; and capillary dressings.
Characteristics of these categories of dressings and the specific dressings used in this review are
provided in Appendix 1 of this review. Wounds are classified as clean, clean-contaminated,
contaminated and dirty/infected.



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The Cochrane protocol identified 23 potentially eligible studies, of which 11 were included (Ajao 1977,
Chrintz 1989, Gardezi 1983, Holm 1998, Law 1987, Michie 1994, Moshakis 1984, Pham 1993, Scott
1982, Terrill 2000, Wikblad 1995). The update by the NCC identified two potentially eligible new
studies, both of which were included in this review (Cosker 2005, Wynne 2004). A further study
(Burrows 2000) was a systematic review of three studies, all of which were already included in this
evidence review. Reasons for exclusion of studies are listed in Appendix F18. Six studies were
published in languages other than English and were not translated.

3809 patients were included in the 13 studies. Nine studies randomised between 100 and 300
participants. Two studies included less than 100 participants (Michie 1994, Holm 1998) and two
studies randomised over 700 participants (Chrintz 1989, Wynne 2004).
Four studies were conducted in the UK (Cosker 2005, Law 1987, Moshakis 1984, Scott 1982); the rest
were carried out in Denmark (Chrintz 1989, Holm 1998), Sweden (Wikblad 1995), Belgium (Pham
1993), Australia (Terrill 2000, Wynne 2004), USA (Michie 1994), Nigeria (Ajao 1977), and Pakistan
(Gardezi 1983). All studies included adults and three also included children (Chrintz 1989, Gardezi
1983, Terrill 2000). All studies were of parallel group design except one that was of split wound design
(Michie 1994).

Seven of the 13 studies investigated wound dressings applied after clean surgery (Cosker 2005, Law
1987, Moshakis 1984, Phan 1993, Scott 1982, Terrill 2000, Wikblad 1995, Wynne 2004), however one
of these (Terrill 2000) also included trauma wounds (~50%) and the incision wounds were not reported
separately. Four studies included patients undergoing clean and clean-contaminated surgery (Chrintz
1989, Gardezi 1983, Holm 1998, Michie 1994), and one had patients receiving either clean or
contaminated surgery (Ajao 1977).

Five studies included in the review had three or more relevant comparison arms (Cosker 2005, Law
1987, Terrill 2000, Wikblad 1995, Wynne 2004), resulting in 23 comparisons overall. The following
types of comparison were investigated:
Dressing versus no dressing: two studies, three comparisons (Law 1987 (2 comparisons),
Phan 1993)
Polyurethane film (Opsite) 5 days versus no dressing (Law 1987)
Dry gauze 5 days versus no dressing (Law 1987)
Dry gauze 5 days versus no dressing, but vaseline ointment (Phan 1993)
Dressing for longer period versus reduced period: two studies (Ajao 1977, Chrintz 1989)
Cotton gauze and elastoplast dressing; 7 to 10 days versus 1 to 1.5 days (Ajao 1977)
Sterile dressing; until suture removal versus 1 day (Chrintz 1989)
[2V] Hydrocolloid 10 days versus dry gauze (Mepore) 2 days two variables changing
at once (duration and material) (Holm 1998)
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[2V] Polyurethane membrane until suture removal versus gauze 2 days - two variables
changing at once (duration and material) (Gardezi 1983)

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Dressing 1 versus dressing 2
Hydrocolloid dressing versus conventional dressing (four studies: Holm 1998, Michie 1994,
Wikblad 1995, Wynne 2004)
Hydrocolloid versus conventional absorbent dressing; both 5 days (Wikblad 1995)
[2V] Hydrocolloid 5 days versus dry absorbent dressing (Primapore) 2 days two
variables changing at once (duration and material) (Wynne 2004)
[2V] Hydrocolloid 10 days versus dry gauze (Mepore) 2 days two variables changing
at once (duration and material) (Holm 1998)
Hydrocolloid versus bismuth tribromophenate impregnated gauze, both 7 to 10 days
with replacement of dressing: one study (Michie 1994) also split wound randomisation
the GDG excluded this study from the analysis because bismuth tribromophenate is
not used in the UK.
Vapour-permeable films and membranes versus conventional dressings (four studies: Cosker
2005, Gardezi 1983, Moshakis 1984, Law 1987)
Polyurethane film (Opsite) 5 days versus dry gauze 5 days (Law 1987)
Polyurethane membrane (Opsite post-op, permeable with absorbent pad) versus
absorbent pad dressing (Primapore); both used in accordance with manufacturers
instruction and 2-3 dressing changes over 10 period (Cosker 2005)
[2V] Polyurethane membrane until suture removal versus gauze 2 days - two variables
changing at once (duration and material) (Gardezi 1983)
[2V] Polyurethane membrane (Tegaderm, semi-permeable) 6 to 8 days versus gauze
changed after 1 day then changed by patient up to 6 - 8 days - two variables changing
at once (material and number of changes) (Moshakis 1984)
Polyurethane membrane (Tegaderm, semi-permeable) with absorbent pad versus
absorbent pad dressing (Primapore); both used in accordance with manufacturers
instruction and 2-3 dressing changes over 10 day period (Cosker 2005)
Polyurethane membrane 1 (Opsite post-op; permeable, with absorbent pad) versus
polyurethane membrane 2 (Tegaderm, semi-permeable, with absorbent pad); both used in
accordance with manufacturers instruction and 2 to 3 dressing changes over 10 day period
(Cosker 2005)
Hydroactive dressing versus conventional dressing: two studies (Wikblad 1995, Wynne 2004)
Hydroactive versus conventional absorbent dressing; both 5 days (Wikblad 1995)
[2V] Hydroactive 5 days versus conventional absorbent dressing 2 days; two variables
changing at once (material and duration) (Wynne 2004)
Hydroactive dressing versus hydrocolloid dressing: two studies (Wikblad 1995, Wynne 2004)
Both studies had the dressings in place for five days for each group

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Other comparisons: one study (Scott 1982 wound isolator versus standard gamma irradiated
adhesive dressing)
Low adherence dressings and wound contact materials versus each other (I study: Terrill
2000)

All studies but one (Moshakis 1984) reported wound infection as an outcome, but this was measured
at varying times and there were different definitions of infection. The Moshakis study did not measure
wound infection, but wound discharge was considered as part of an overall score. Therefore this study
was not included in the analysis for the primary outcome. Three studies examined cosmetic
appearance (Holm 1998, Michie 1994, Moshakis 1984), five studies reported pain/tenderness (Gardezi
1983, Michie 1994, Moshakis 1984, Terrill 2000, Wikblad 1995), four reported patient acceptability
(Holm 1998, Michie 1994, Moshakis 1984, Wynne 2004), six reported ease of dressing removal (Holm
1998, Law 1987, Michie 1994, Terrill 2000, Wikblad 1995, Wynne 2004), and two reported blistering
(Cosker 2005, Wikblad 1995).

Characteristics of studies included in the Health Economic review (Appendix
D18)
Three studies were included in the health economic review (Terrill 2000, Wikblad 1995, Wynne 2004).
These three studies were also included in the clinical review.

Methodological quality of included clinical studies (Appendix E18)
The method of randomisation was reported in two studies, of which one was classified as adequate
(Michie 1994) and one was classified as inadequate (Chrintz 1989; date of birth). The rest of the
studies did not state the method of randomisation.

Allocation concealment was reported in three studies, of which an adequate or partially adequate
method was described in two studies (Phan 1993, Wynne 2004) and an inadequate method in one
(Chrintz 1989). The rest of the studies did not state or were unclear about the method of allocation
concealment.

Only one study stated that the outcome assessors were blinded (Wikblad 1995) and two described
inadequate blinding (Cosker 2005, Wynne 2004). The rest of the studies did not say.

There were no withdrawals in two studies (Ajao 1977, Gardezi 1983). Five studies had a loss to follow
up of less than 10% (Chrintz 1989, Law 1987, Michie 1994, Moshakis 1984, Terrill 2000), two had 15%
(Phan 1993, Wynne 2004), one had 33% (Wikblad 1995), one had 54% withdrawals in one of the
groups (Holm 1998). Finally the Scott 1982 study had 62% loss to follow up in the study group and
58% loss in the control group.

Only two studies (Phan 1993, Wynne 2004) reported an a-priori sample size power calculation.
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Four studies (Chrintz 1989, Gardezi 1983, Moshakis 1984, Phan 1993, Wynne 2004) reported that the
baseline characteristics were comparable. Four studies reported differences between groups (Ajao
1977: more contaminated surgery in short duration group; Cosker 2005: Opsite group significantly
older; Holm 1998: higher proportion of transverse wounds in Comfeel group; Terrill 2000: wound site
differences; Wynne 2004: type II diabetes (diet) higher in Primapore group). The other studies did not
report baseline characteristics.

All but one study (Moshakis 1984) measured rates of SSI. One study (Law 1987) measured the rate of
SSI at up to 5 days. The GDG therefore did not consider this study further. One study (Wynne 2004)
reported that the median presentation of wound infection was 38.5 days (range 34 to 43 days).

The risk of bias was assessed for each included study and four studies were assessed as being at
high risk of bias (Chrintz 1989 allocation concealment; Law 1987 too short follow up; Holm 1998,
Scott 1982 very high loss to follow up). All studies except Chrintz 1989 were considered to be too
biased to analyse further. The Ajao 1977 study is regarded as of medium bias (difference in number of
contaminated wounds), as is the Wikblad 1995 study (33% loss to follow up for SSI rate). These
studies and the Chrintz study were examined in sensitivity analyses where appropriate.

Methodological quality of health economic studies (Appendix E18)
The three studies (Terrill 2000, Wikblad 1995, Wynne 2004) included in the health economics review
had very limited costing studies. These three studies only included the costs of dressings (i.e. the
product of frequency of dressing and unit costs per dressing). They did not formally include relevant
costs such as the costs associated with nursing time in changing dressings. The authors also failed to
include the costs of complications, such as wound infections, which might have also affected the
authors results.

Results

Dressing versus no dressing

Primary outcome rate of SSI
One study (Phan 1993) in patients undergoing compared dry gauze dressing for 5 days with no
dressing and vaseline ointment. There was no significant difference between the two groups; RR 0.78
(95%CI 0.49, 1.26).






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Figure 1: dressing versus no dressing plus ointment rate of SSI
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Dressing in place for longer period versus reduced period

Primary outcome rate of SSI
Three studies (Ajao 1977, Chrintz 1989, Gardezi 1983) investigated if leaving the dressing on for a
shorter period affected the rate of SSI. The Gardezi study compared different dressings and so
changed two variables at once; the confidence interval was also wide. The Chrintz study was quasi
randomised, and showed little difference between groups. The Ajao 1977 study had too wide a
confidence interval to draw conclusions. In addition, this study was based in Nigeria and included
patients with a variety of types of surgery and wound contamination (clean and contaminated) and
addressed specific African problems (high temperature and humidity, sweat trapped within the
dressing, malnutrition).

Figure 2: dressing longer duration versus shorter duration rate of SSI
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Secondary outcome pain
Only the Gardezi study investigated pain and the confidence interval was too wide to draw
conclusions.

Figure 3: dressing longer duration versus shorter duration pain
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Dressing 1 versus dressing 2

Hydrocolloid dressing versus conventional dressing

Primary outcome rate of SSI
Two studies compared hydrocolloid and conventional dressings (Wikblad 1995 and Wynne 2004).
Both had an absorbent dressing as the comparator, but Wikblad applied the dressing for five days in
both groups and Wynne 2004 applied hydrocolloid for five days and Primapore for only 2 days,
i.e.,changing two variables at once. In addition, this study showed a significantly higher proportion of
patients with type II diabetes (diet) in the Primapore group. The Wikblad study reported the number of
infections in the conventional and non-conventional groups, but did not give the results separately for
the hydrocolloid and hydroactive groups. Therefore this analysis assumed a worst case of the two
infections in the hydrocolloid group (similarly for the analysis of hydroactive versus conventional). This
study had a 33% loss to follow up.

Figure 4: hydrocolloid dressing versus conventional dressing rate of SSI
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Secondary outcomes

Pain/discomfort (Figure 5):
Although there was some loss to follow up for this outcome (absorbent 9%, hydrocolloid 21%), The
Wikblad study showed that patients in the hydrocolloid group found significantly more pain on dressing
removal than those receiving conventional dressings. Patients in the Wynne study found significantly
more discomfort in the hydrocolloid group, however, this study did change two variables at once, and it
is not necessarily reasonable to draw conclusions about the different types of dressing.

Figure 5: hydrocolloid dressing versus conventional dressing pain/discomfort on dressing
removal
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The Wikblad study also reported that it was significantly easier to remove the absorbent dressing than
the hydrocolloid.

Adverse effects
In the Wikblad study there was insufficient evidence to decide if there was a difference in erythema.

Figure 6: hydrocolloid dressing versus conventional dressing erythema
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The Wikblad study also showed no blistering in either group.

Patient acceptability
Patients in the Wynne study were reported to have statistically significantly more satisfaction in the
hydrocolloid group on each of day 1 and day 2. However, this study changed two variables at once
(dressing and duration), so there was insufficient information to compare the two dressings directly.
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Cost-effectiveness
Two studies compared hydrocolloid and conventional dressings (Wikblad 1995, Wynne 2004).

In terms of total dressing costs, Wikblad 1995 found that hydrocolloid dressings were more expensive,
with a mean cost per patient of $3.60, whereas conventional absorbent dressings were cheaper with a
mean cost per patient of $0.73. However, conventional absorbent dressings required more dressing
changes (1.7 per patient compared to 1.2), The authors suggested that the fact that patients receiving
hydrocolloid required less dressing changes, would not compensate for the large difference in price
between these and conventional absorbent dressings, as the difference in staff costs ($0.50 per
absorbing dressing change) did not outweigh the cost savings generated, although this was not
formally assessed. Wynne 2004 found similar results. In terms of total dressing costs, hydrocolloid
dressings were the more expensive, with a median cost of AU$3.94 compared with conventional
absorbent dressings at AU$0.52.

Hydroactive dressing versus conventional dressing
Two studies (Wikblad 1995, Wynne 2004) compared a hydroactive dressing (Cutinova hydro and
Opsite respectively) with a conventional dressing. The Wynne study also had dressings in place for
different time periods, and so two variables were changed at once. As mentioned above, the Wikblad
study reported the number of infections in the conventional and non-conventional groups, but did not
give the results separately for the hydrocolloid and hydroactive groups. Therefore this analysis
assumed a worst case of the two infections in the hydroactive group (similarly for the analysis of
hydrocolloid versus conventional). In both studies there was too much uncertainty to draw conclusions
about differences in the rate of SSI.

Figure 7: hydroactive dressing versus conventional dressing rate of SSI

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Secondary outcomes

Pain/discomfort (Figure 8):
Although there was some loss to follow up for this outcome (absorbent 9%, hydroactive 26%), the
Wikblad study showed that patients in the hydroactive group found significantly more pain on dressing
removal than those receiving conventional dressings. Patients in the Wynne study found significantly
more discomfort in the hydroactive group, however, this study did change two variables at once, and it
is not necessarily reasonable to draw conclusions about the different types of dressing.

Figure 8: hydroactive dressing versus conventional dressing pain/discomfort on dressing
removal
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The Wikblad study also reported that it was significantly easier to remove the absorbent dressing than
the hydroactive dressing.

Adverse effects
In the Wikblad study there was significantly more erythema in the hydroactive group compared to the
Primapore absorbent dressing. The study also reported the numbers of blisters, but there was too
much uncertainty to draw conclusions, and the GDGs view was that the blisters were caused by the
adhesive at the edges of the dressing and was not related to wound management.

Figure 9: hydroactive dressing versus conventional dressing adverse effects
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Cost-effectiveness
Two studies compared hydroactive and conventional dressings (Wikblad 1995, Wynne 2004).

In terms of total dressing costs, Wikblad 1995 found that hydroactive dressings were more costly, with
a mean cost per patient of $3.34 compared with conventional absorbent dressings at a mean cost per
patient of $0.73. However, conventional absorbent dressing required more dressing changes (1.7 per
patient compared to 1.2). The authors suggested that the fact that patients receiving hydroactive
required less dressing changes, would not compensate for the large difference in price between these
and conventional absorbent dressings, as the difference in staff costs ($0.50 per absorbing dressing
change) did not outweigh the cost savings generated, although this was not formally assessed. Wynne
2004 found similar results. In terms of total dressing costs, hydroactive dressings were more costly,
with median cost of AU$1.59, compared with conventional absorbent dressings at a median cost of
AU$0.52 (IQR: $0.52 to $0.52).

Hydroactive dressing versus hydrocolloid dressing
Two studies (Wikblad 1995, Wynne 2004) compared a hydroactive dressing (Cutinova hydro and
Opsite respectively) with a hydrocolloid dressing. In all groups the dressings were left on for five days.
The Wikblad study did not report the number of infections separately for the hydrocolloid and
hydroactive groups. In the Wynne study there too much uncertainty to draw conclusions about
differences in the rate of SSI (Figure 10).

Figure 10: hydroactive dressing versus hydrocolloid dressing rate of SSI
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Secondary outcomes

Pain/discomfort (Figure 11):
Although there was some loss to follow up for this outcome (hydrocolloid 21%, hydroactive 26%), the
Wikblad study showed that patients in the hydroactive group found significantly more pain on dressing
removal than those receiving hydroactive dressings. Patients in the Wynne study found little difference
between the dressings in terms of discomfort.




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Figure 11: hydroactive dressing versus hydrocolloid dressing pain/discomfort on dressing
removal
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Patient acceptability
Patients in the Wynne study had more dissatisfaction in the hydroactive group, but it was not a
statistically significance difference (p=0.09).

Figure 12: hydroactive dressing versus hydrocolloid dressing patient dissatisfaction
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Adverse effects
In the Wikblad study there was significantly more erythema with the hydroactive dressing compared to
the hydrocolloid dressing. The study also reported the numbers of blisters, but there was too much
uncertainty to draw conclusions (Figure 13).

Figure 13: hydroactive dressing versus hydrocolloid dressing adverse effects
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Cost-effectiveness
Two studies compared hydroactive and hydrocolloid dressings (Wikblad 1995, Wynne 2004).

In terms of total dressing costs, Wikblad 1995 found that the mean cost per patient for hydrocoactive
and hydrocolloid dressings was similar ($3.60 and $3.34, respectively). The authors found that the
mean number of dressing changes were the same for the two groups (1.2 per patient).

In contrast, Wynne 2004 found that the median dressing cost per patient was only AU$1.59 for
hydroactive dressings and much higher for hydrocolloid dressings at AU$3.93.

Vapour-permeable films and membranes versus conventional dressings

Primary outcome rate of SSI
Three studies compared a polyurethane membrane with a conventional dressing (Cosker 2005,
Gardezi 1983, Moshakis 1984). The Moshakis study was excluded from the analysis for this outcome
because SSI was not explicitly stated as an outcome, and wound discharge was included as part of an
overall score. The type of PU membrane was either permeable or semi-permeable and the comparator
dressing also differed. In some comparisons the time the dressing was in place varied, or the number
of dressing changes was different between arms, thus changing two variables at once. For this reason
combination of studies was not carried out in a meta-analysis.

None of the comparisons had sufficient information (wide CIs) to determine the effect of the different
dressings on the rate of SSI (Figure 14).

Figure 14: vapour permeable polyurethane dressing versus conventional dressing rate of SSI
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Secondary outcomes

Acceptability of dressing
In the Moshakis 1984 study, both patients and nurses rated on a 1 to 10 VAS, the polyurethane
membrane (in place for 6 to 8 days) to be significantly better than gauze changed frequently, in terms
of discomfort and pain, and troublesomeness, when used after breast surgery (Figure 15).

Adverse effects
The Cosker 2005 study had, as its primary outcome, the incidence of blistering. However, the GDG
excluded this outcome from the analysis because blistering would have derived from the adhesive on
the edges of the pad, rather than being related to the wound.

Figure 15: vapour permeable polyurethane dressing versus conventional dressing discomfort
and troublesomeness
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Polyurethane membrane 1 (Opsite post-op; permeable, with absorbent pad) versus
Polyurethane membrane 2 (Tegaderm, semi-permeable, with absorbent pad)

Primary outcome rate of SSI
One study (Cosker 2005) compared two types of polyurethane dressing in orthopaedic surgery and
found there was too much uncertainty to determine if there was a difference in the rate of SSI (Figure
16).

Figure 16: PU membrane permeable versus PU membrane semi-permeable rate of SSI
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Low adherence dressings and wound contact materials

Cost effectiveness
One study (Terrill 2000) compared three different types of low adherence dressings: paraffin-
impregnated gauze, cellulose acetate fibre coated with a petrolatum emulsion and polyamide net
dressing impregnated with silicone gel.

This study found that polyamide net dressings impregnated with silicone gel were the most expensive
dressing at AU$5.87 per sheet, whilst paraffin-impregnated gauze and cellulose acetate fibre coated
with a petrolatum emulsion both cost AU$0.48 per sheet. However, this costing exercise only took into
account the unit cost of the dressing, and did not include the frequency of dressing changes nor the
labour costs associated with dressing change. These important omissions could have biased the
authors results, for example cellulose acetate fibre coated with a petrolatum emulsion was found to be
more difficult to apply. Therefore, probably more nursing time was needed to apply the dressings
making the total cost of the dressing more expensive.

GDG Consensus
GDG consensus was that gauze should not be used because it disturbs primary healing and
traumatises the maturing wound bed when it is removed. If a surgical wound healing by primary
intention requires a dressing (eg. for exudate management or protection), a low adherent modern
dressing should be used.


Evidence statements and recommendations

Level of
evidence
Evidence statements
1+

There was fair evidence in patients undergoing head and neck cancer surgery, to
show no significant difference in SSI rate between the use of a dry gauze
dressing for 5 days compared with no dressing and vaseline ointment.
2+ Timing of dressing removal
There was fair evidence, in a large study of clean and clean-contaminated
wounds, to show little difference in the rate of SSI between the use of a sterile
dressing until suture removal compared with a dressing for the first 24h after
operation only.

1-
Hydrocolloid dressings
There was insufficient evidence in two studies to decide if there was a difference
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1+


1-

HE
in SSI rate between hydrocolloid and conventional absorbent dressings.
For secondary outcomes, there was fair evidence to show significantly more pain
in the hydrocolloid group on dressing removal than for those receiving
conventional dressings. It was also significantly easier to remove the absorbent
dressing.
There was insufficient evidence to determine if there is a difference in
acceptability to patients between hydrocolloid and conventional dressings.
There was fair evidence to show that the consumable costs of conventional
dressings were lower than for hydrocolloid dressings, but conventional dressing
required more dressing changes.
There was insufficient evidence to decide whether hydrocolloid dressings are cost
effective compared to conventional dressings.

1-

1+


1+

HE
Hydroactive dressings
There was insufficient evidence in two studies to decide if there was a difference
in SSI rate between hydroactive and conventional absorbent dressings.
In terms of secondary outcomes, there fair evidence to show there was
significantly more pain on dressing removal, and significantly more erythema in
the hydroactive group compared with those receiving conventional dressings. It
was also significantly easier to remove the conventional dressing.
There was fair evidence to show that the consumable costs of conventional
dressings were lower than the use of hydroactive dressings but conventional
dressings require more dressing changes.
There was insufficient evidence to decide whether hydroactive dressings are cost
effective compared to conventional dressings.

1-

1+


1-

HE
Hydroactive versus hydrocolloid dressings
There was insufficient evidence to decide if there was a difference in SSI rate
between hydroactive and hydrocolloid dressings.
In terms of secondary outcomes, there was fair evidence to show significantly
more pain on dressing removal and significantly more erythema in the hydroactive
group than for those receiving hydrocolloid dressings. However, there was little
difference in discomfort in a second study.
Patients in one study had more dissatisfaction in the hydroactive group, but it was
not a statistically significance difference (p=0.09).
There was some evidence that the consumable costs of hydrocolloid dressings
were higher than for hydroactive dressings but the number of dressing changes
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was similar between the two dressing types.
There was insufficient evidence to determine whether hydroactive dressings are
cost effective compared to hydrocolloid dressings.

1-


1+
Vapour permeable polyurethane dressings
There is insufficient evidence in two studies to determine if there is a difference in
rates of SSI between vapour permeable polyurethane dressings and conventional
dressing, or between permeable PU and semi-permeable PU dressings.
There is fair evidence to show that both patients and nurses found a polyurethane
membrane to be significantly better than gauze changed frequently, in terms of
discomfort and pain, and troublesomeness, when used after breast surgery.
4
GDG consensus was that gauze should not be used because it disturbs primary
healing and traumatises the maturing wound bed when it is removed. If a surgical
wound healing by primary intention requires a dressing (eg. for exudate
management or protection), a low adherent modern dressing should be used.
1

Grade

Recommendation
D
If a surgical wound healing by primary intention requires a dressing (for exudate
management or protection), a low adherent, modern dressing should be used.
2
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APPENDIX 1 Classification and characteristics of wound dressings

Source: British National Formulary (BNF 2005)

1. Alginate dressings
2. Foam dressings
3. Hydrogel dressings
4. Hydrocolloid dressings
5. Vapour-permeable films and membranes
6. Low adherence dressing and wound contact materials
7. Odour absorbent dressings
8. Dressing packs
9. Surgical absorbents
10.Capillary dressings

1. Alginate dressings
The gelling characteristics of alginate dressings vary according to the product used. Some products
only gel to a limited extent to form a partially gelled sheet that can be lifted off; others form an
amorphous gel that can be rinsed off with water or physiological saline. A secondary covering is
needed. They are highly absorbent and are therefore suitable for moderately or heavily exuding
wounds, but not for eschars or for dry wounds
2. Foam dressings
Foam dressings vary from products that are suitable for lightly exuding wounds to highly absorbent
structures for heavily exuding wounds. They may also be used as secondary dressings. In
hypergranulating (or overgranulating) tissue (which may arise from the use of occlusive dressings such
3. Hydrogel dressings
Hydrogel dressings are most commonly supplied as an amorphous, cohesive material that can take up
the shape of a wound. A secondary covering is needed. These dressings are generally used to donate
liquid to dry sloughy wounds and facilitate autolytic debridement but they may also have the ability to
absorb limited amounts of exudate. Hydrogel sheets are also available which have a fixed structure;
such products have limited fluid handling capacity. Hydrogel sheets are best avoided in the presence
of infection.
4. Hydrocolloid dressings
Hydrocolloid dressings are usually presented as an absorbent layer on a vapour-permeable film or
foam. Because of their impermeable nature, hydrocolloid dressings facilitate rehydration and autolytic
debridement of dry, sloughy, or necrotic wounds; they are also suitable for promoting granulation.
Fibrous dressings made from modified carmellose fibres resemble alginate dressings (e.g. Aquacel);
these are not occlusive.
5. Vapour-permeable films and membranes
Vapour-permeable films and membranes allow the passage of water vapour and oxygen but not of
water or micro-organisms, and are suitable for mildly exuding wounds. They are highly conformable,
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convenient to use, provide a moist healing environment, and some may permit constant observation of
the wound. However, water vapour loss may occur at a slower rate than exudate is generated, so that
fluid accumulates under the dressing, which can lead to tissue maceration and to wrinkling at the
adhesive contact site (with risk of bacterial entry). Newer versions have increased moisture vapour
permeability; some also contain water-soluble antimicrobials. Despite these advances vapour-
permeable films and membranes remain less suitable for large heavily exuding wounds and are
probably not suitable for chronic leg ulcers. They are most commonly used as secondary dressings
over alginates or gels; they are also sometimes used to protect fragile skin of patients at risk of
developing minor skin damage.
6. Low adherence dressing and wound contact materials
Low adherence dressings and wound contact materials are used as interface layers under secondary
absorbent dressings.
Tulle dressings are manufactured from cotton or viscose fibres which are impregnated with white or
yellow soft paraffin to prevent the fibres from sticking, but this is only partly successful and it may be
necessary to change the dressings frequently. The paraffin reduces absorbency of the dressing.
Dressings with a reduced content of soft paraffin (i.e. Paratulle and Unitulle) are less liable to
interfere with absorption; those containing the traditional amount (such as Jelonet) have been
considered more suitable for skin graft transfer.
Medicated tulle dressings are not generally recommended for wound care. Although hypersensitivity is
unlikely with chlorhexidine gauze dressing, its antibacterial efficacy has not been established.
Povidoneiodine fabric dressing is a knitted viscose dressing with povidoneiodine incorporated in
a hydrophilic polyethylene glycol basis; this facilitates diffusion of the iodine into the wound and
permits removal of the dressing by irrigation. The iodine has a wide spectrum of antimicrobial activity
but it is rapidly deactivated by wound exudate; systemic absorption of iodine may occur.
Perforated film absorbent dressings partially overcome the problems of adherence but they are
suitable only for wounds with mild to moderate amounts of exudate; they are not appropriate for leg
ulcers or for other lesions that produce large quantities of viscous exudate.
Knitted viscose primary dressing is an alternative to tulle dressings for exuding wounds; it is
sometimes used as the initial layer of multi-layer compression bandaging.
7. Odour absorbent dressings
These dressings have an important role in absorbing the odour of infected wounds. Some dressings
may also benefit wound healing by binding bacteria, but this effect awaits confirmation.
8. Dressing packs
The role of dressing packs is very limited. They are used to provide a clean or sterile working surface;
packs shown below include cotton wool balls, but they are not recommended for use on wounds.
9. Surgical absorbents
Surgical absorbent dressings, applied directly to the wound, have many disadvantages, since they
adhere to the wound, shed fibres into it, and dehydrate it; they also permit leakage of exudate (strike
through) with an associated risk of infection. Surgical absorbents may be used as secondary
absorbent layers in the management of heavily exuding wounds.
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10. Capillary dressings
Capillary dressings consist of an absorbent core of hydrophilic fibres sandwiched between two low-
adherent wound-contact layers. Wound exudate is taken up by the dressing and retained within the
highly absorbent central layer. The dressing may be applied intact to relatively superficial areas, but for
deeper wounds or cavities it may be cut to shape to ensure good contact with the wound base.
Multiple layers may be applied to heavily exuding wounds to further increase the fluid-absorbing
capacity of the dressing. Capillary dressings can be applied to a variety of wounds but they are contra-
indicated for heavily bleeding wounds or arterial bleeding.
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Description of wound dressings tested in the studies

Dressing (manufacturer) Description (reproduced from the study reports) Study reference

Hydrocolloid dressings

DuoDERM
(Convatec/Bristol-Myer Squibb)

Sterile dressing which contains hydrocolloids in a
polymer matrix, which is self-adhesive to normal
skin; does not allow passage of microbes, water, or
oxygen
Wikblad 1995
Michie 1994
Comfeel Plus
(Coloplast A/S Denmark)

Transparent dressing consisting of a outer semi-
permeable polyurethane membrane with a thin
absorbent and adhesive hydrocolloid interface,
which creates moist environment between the
polyurethrane membrane and the surface of the
wound
Holm 1998
Cutinova hydro
(Beiersdorf AG, Hamburg)

New type / successor to hydrocolloids
contains highly absorbent particles embedded in a
self-adhesive polyurethane matrix; it is covered by a
polyurethane film and is water-resistant and
permeable to oxygen and water vapour
Wikblad 1995
Vapour-permeable films and membranes

Opsite

Transparent polyurethane film dressing Law 1987
Cosker 2005

Tegaderm (3M UK) Transparent semi-permeable polyurethane
membrane (water resistant, permeable to oxygen
and water vapour); it is coated on one surface with
a hypoallergenic water resistant adhesive and is
carried on a special frame that allows easy
application
Moshakis 1984
Cosker 2005

Polyurethane membrane Adhesive, transparent film dressing, no specific
manufacturer mentioned
(Gardezi 1983
Low adherence dressing and wound contact materials

Adaptic
(Johnson and Johnson)
Consists of an open mesh of cellulose acetate fibres
coated with a petrolatum emulsion containing a
surfactant that reduces surface tension and allows
easier passage of exudate
Terrill 2000

Mepitel
(Molnlycke AB, Sweden)
Consists of a net of polyamide impregnated with a
silicone gel; it has an open mesh structure, allowing
exudate to pass into a secondary absorbent
dressing; it does not adhere to the wound but to the
Terrill 2000
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surrounding healthy adjacent skin
Xeroform
(Sherwood Medical Company, St
Louis, MO, USA)
Cotton gauze dressing impregnated with bismuth
tribromophenate

Michie 1994

Mepore
(Molnlycke AB, Sweden)
Conventional dry gauze dressing that is routinely
used for surgical wound dressing
Holm 1998
Jelonet
(Johnson and Johnson)
Traditional paraffin-impregnated gauze

Terrill 2000
Traditionally used cotton gauze
and an elastoplast dressing
Air-tight and relatively water-tight; left on the wound
for 7-10 days
Ajao 1997
Other comparisons

Qualifar Pure vaseline wound ointment

Phan 1993

Wound isolator Used for a surgery of the femoral neck
Contains wounds in a sterile environment (covers
the wound and supplies a sterile air) until they have
healed and prevents direct contact and airborne
cross-infections


Scott 1982
1
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6.19 Clean versus sterile techniques 1
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Objective
To examine the clinical and cost effectiveness of clean versus sterile techniques for dressing
changes for the prevention of surgical site infection in surgical sites healing by primary
intention and the promotion of wound healing in infected surgical sites healing by secondary
intention.

Criteria for considering studies for this review

Types of comparisons

The following type of comparison was investigated:

Clean versus sterile dressing change techniques

Search Strategy
Details of the general approach to searching are reported in section 5.3. The search strategy
for this review is provided in Appendix C19.

Characteristics of study included in the clinical effectiveness review
(Appendix D19)
Of the seventeen papers identified, there were four potentially eligible studies, one of which
was included in the review (Stotts 1997). Reasons for exclusion are listed in Appendix F19.

There were no studies comparing clean and sterile dressing change techniques for healing by
primary intention, but one study (Stotts 1997) compared techniques in wounds healing by
secondary intention.

The Stotts study was conducted in the USA, in 30 patients who had undergone elective
gastrointestinal operations, and who had wounds healing by secondary intention. The
operations were classified as: clean (one), clean contaminated (21), contaminated (seven)
and dirty (one). The study did not explicitly state if the wounds were infected or dirty, but this
was implied.



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Characteristics of included studies in the Health Economics review
(Appendix D19)
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Two studies that compared a sterile dressing change technique to a clean dressing change
technique were identified in the health economics review (Lawson 2003, Stotts 1997). One of
these studies (Stotts 1997) was also included in the clinical review. A further study (Lawson
2003) was included.

The study by Lawson was undertaken in the USA in patients admitted into acute care units
with surgical wounds healing by secondary intention. The study was based on a before and
after study design comparing the use a clean dressing change technique as opposed to a
sterile dressing change technique.

Methodological quality of study included in clinical effectiveness review
(Appendix E19)
Stotts 1997 was a small pilot study. The method of randomisation and allocation was unclear.
The outcome assessor was not blinded for the healing outcome. Duration of follow-up period
for wound healing was short at 4 days.

Methodological quality of studies included in the Health Economic
review (Appendix D19)
The study by Stotts et al. (1997) was based on a pilot study, with a corresponding small study
sample. Although the study was likely to be underpowered to detect any statistically
significant differences in the rate of healing, statistically significant differences in costs
between the two groups were identified. The study by Lawson et al. (2003) was based on a
before-after study, with is subject to potential bias as the two treatment groups were not
followed-up in the same time periods. The costing analyses of both these studies also failed
to include the time costs associated with healthcare staff changing dressings.

Results

Dressing changing technique in patients with wounds healing by secondary intention
Stotts 1997 compared clean versus sterile dressing change techniques for surgical wounds in
the postoperative period with respect to the rate of wound healing by secondary intention.

Primary outcome rate of healing
The authors measured changes in wound volume, and when analysed with the Mann-Whitney
U test the authors reported no significant difference was found between the two groups
(p<0.49). The final wound volume is compared for the two groups in figure 1, and shows a
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wide confidence interval (Mean difference: -3.80 cm3 (95%CI -9.96, 2.36)). In addition, the
follow up time was short (mean 4 days).

Figure 1: Rate of wound healing
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Cost-effectiveness
Two studies compared sterile dressing change technique to clean dressing change technique.
Both these studies found similar results and concluded that the use of a clean dressing
change technique was cost-effective when compared to a sterile dressing change technique.

Stotts (1997) found that the average cost of dressing change consumables for each change
of dressing was significantly lower in the clean technique group than in the sterile technique
group ($12.38 + $5.80, compared to $21.97 + $12.80, respectively). 14
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Lawson et al. (2003) found similar results as they observed no significant differences in
wound infection rates between the two groups, and found that a change to clean dressing
technique was associated with savings of approximately $1,520 in consumables per year for
the two acute care nursing units involved, and reduced nursing time required in dressing
change, although this was not costed.

In terms of cost-effectiveness results, the two studies included in the health economics review
both concluded that the use of a clean sterile dressing change reduced the costs of dressing
change consumables. One study also found a reduction in nursing time required in clean
dressing change, although these savings in staff time were not included in the cost analysis.

GDG consensus
GDG consensus was that the individual patients risk of infection and the reduced cost of a
clean dressing technique should be taken into account by the health professional when
deciding whether to use clean or sterile dressing changing techniques.


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Evidence statements and recommendations 1
2
Level of
evidence
Clinical Effectiveness Evidence Statement
1-

There was insufficient evidence in a pilot study to show if there is a significant
difference in the rate of wound healing for a clean versus sterile dressing
change technique for healing by secondary intention.

HE
Two economic evaluations found that the use of a clean dressing change
technique reduced the costs of wound dressing consumables when compared to
a sterile dressing change technique for surgical sites healing by secondary
intention.

4
GDG consensus was that the individual patients risk of infection and the
reduced cost of a clean dressing technique should be taken into account by the
health professional when deciding whether to use clean or sterile dressing
techniques.

3
4



Grade

Recommendation
D The individual patients risk of infection and the reduced cost of a clean dressing
technique should be taken into account by the healthcare professional when
deciding whether to use clean or sterile dressing techniques.

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6.20 Postoperative wound cleansing 1
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Introduction
The review is an update of a Joanna Briggs systematic review, Effectiveness of solutions,
techniques, and pressure in wound cleansing (Fernandez, Griffiths and Ussia, 2004)
published by the New South Wales Centre for Evidence-Based Health Care (A Collaborating
Centre of The Joanna Briggs Institute, Australia).

Objective
The objective of this review is to examine the clinical and cost effectiveness of wound
cleansing solutions, techniques and pressure used in the prevention of surgical site infection
and in promoting post surgical wound healing.

Criteria for considering studies for this review

Type of interventions/comparisons

All studies comparing the following interventions for prevention of infection and promotion of
wound healing were included in the review:

Cleansing solutions including tap water, boiled water, distilled water, normal saline,
povidone-iodine, and procaine spirit.
Irrigating pressures (0.5 psi, 8 psi, 13 psi, others) for wound cleansing, and
Techniques (soaking, bathing, swabbing) used for wound cleansing.

Search Strategy
Details of the general approach to searching are reported in section 5.2. The search strategy
for this review is provided in Appendix C20.

Characteristics of Included Studies (Appendix D20)
The search identied a large number of studies; however, the published review only included
seven (Fraser 1976; Johnson 1985; Meeker 1998; Oladokun 2003; Reiderer 1997; Tay 1999;
Voorhees 1982). Reasons for exclusion are given in Appendix F20.

Two studies were conducted in the UK (Fraser 1976; Johnson 1985), two in the US (Meeker
1998, Vorhees 1982); one in Singapore (Tay 1999) and one in Germany (Riederer,1997).

The following types of comparisons were identified:
38 Solutions for wound cleansing
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1% povidone-iodine versus normal saline (Johnson,1985)
The study was not analysed as the GDG indicated use of procaine spirit is
not common practise in the UK
Tap water versus procaine spirit (Tay 1999)
The study was excluded from the analysis because the GDG indicated that
procaine spirit is not used in UK practice.

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Techniques for wound cleansing
Showering versus no showering: two studies (Voorhees 1982; Riederer 1997)
Bathing versus no bathing: one study (Fraser 1976)
The study was not analysed as the GDG indicated bathing on wards is no
longer carried out in the UK
Soaking in one type of bath versus another (Oladokun 2003)
The study was not analysed as the GDG indicated that use of a Sitz bath is
not practised within the UK
Whirlpool therapy versus conservative treatment (Meeker,1998)
The outcome measure was inflammation. As it is possible for inflammation to
occur without any infection, the GDG consensus was that the study should
not be considered further

There were a total of 203 patients in the two remaining studies (Voorhees 1982; Riederer
1997). Neither of the studies indicated if children were included.

In Riederer 1997 patients had undergone inguinal hernia and abdomino-perineal excision.
Voorhees 1982 indicated that patient had undergone surgery with or without drains.

Reiderer 1997 defined criteria for wound infections as: no irritation; slight redness of the skin;
stitch abscess; wound infection and was assessed two weeks after surgery. A definition was
not provided in Voorhees 1982.

There were no health economics studies identified.

Methodological quality of included studies (Appendix E20)
The method of randomisation was described and inadequate in both studies (Riederer 1997;
Voorhees 1982; alternation, social security number respectively).

Allocation concealment was described and inadequate in both the studies (alternation, social
security number).

Blinding of the outcome assessor was not stated in either of the studies.
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Overall the two studies were regarded as being at moderate risk of bias (Riederer 1997;
Voorhees 1982), and were treated with caution.

Results
Solutions for wound cleansing
There were no studies identified that compared solutions for wound cleansing.

Irrigating pressures for wound cleansing
There were no studies identified that investigated different pressures for wound cleansing.

Techniques for wound cleansing
There were no studies identified that compared the common techniques of wound cleansing
such as swabbing and scrubbing. Two studies compared the effect of postoperative
showering and non-showering.

Comparison between showering and non-showering

Primary outcome rate of SSI
Two studies compared the effect of showering to no showering of patients in the
postoperative period (Riederer 1997, Voorhees 1982); the former study allowed patients to
have a shower on day one and the latter on day two postoperatively. The pooled results of the
studies indicated that the confidence interval was too wide to determine if there was a
difference in the rate of SSI (Figure 1).

Figure 1: rate of SSI

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Secondary outcomes

Rate of healing
One study (Riederer 1997) measured the rate of healing (Figure 2). There was little difference
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in the rate of healing between showering and not doing so; RR: 1.05 (95%CI: 0.93, 1.18)

Figure 2: Rate of healing
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Patient satisfaction
The two quasi randomised studies (Voorhees 1982, Riederer 1997) reported that patients
who were allowed to shower reported a feeling of well-being;

however, a standard measure
was not used. Results are reported for the German study (Riederer 1997) in Figure 3.

Figure 3: Patient feelings

Positive

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Negative
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Evidence statement and recommendations 1
2
Level of
evidence
Evidence statement
1-


2+




2+



There was insufficient evidence in a meta-analysis of two studies to determine
if showering postoperatively reduces the rate of SSI.
There was fair evidence, in a secondary outcome, to show little difference in
the rate of healing between patients who did or did not shower
postoperatively.

There was fair evidence in two studies showing that patients in the showering
group had a feeling of well-being;

however, a standard measure was not used.
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4



Grade

Recommendation
B Patients can choose to shower from 24 hours post operatively, unless
clinically contraindicated.

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6.21 Dressings and topical agents for surgical wounds
healing by secondary intention Part I
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Introduction
This review looks at dressings and topical agents for surgical wound healing by secondary
intention. It is based on a Cochrane review (Vermeulen. Dressings and topical agents for
surgical wounds healing by secondary intention, 2004), which is an update of the Health
Technology Assessment (HTA) report, A rapid systematic review of the clinical and cost
effectiveness of debriding agents in treating surgical wounds healing by secondary intention.
Following discussion with the GDG and NICE, it was agreed that the Cochrane review
(Vermeulen 2004) was considered to have superseded the HTA report. The review was
updated by the NCC in January 2006.

As part of the HTA report, a review of dressings for toenail avulsion was undertaken. This
was updated separately and reported in section 6.22.

Healing by secondary intention refers to healing of an open wound, from the base upwards,
by deposition of new tissue. Delayed healing by secondary intention may be planned, for
example when wounds are contaminated or at high risk of infection, where there is wound
dehiscence (i.e., where the edges of the surgically closed wound split apart, leaving an open
wound) (Graham 1998). Where infection is present within a closed wound, surgeons may
remove sutures or clips in order to allow free drainage of exudate. The wound then heals by
secondary intention.

Objective
To determine the clinical and cost-effectiveness of various dressings and topical agents for
healing by secondary intention, irrespective of whether the secondary intention was planned
or unplanned.

Criteria for considering studies for this review
Types of patient
Patients who have infected or dirty surgical wounds healing by secondary intention. The
review excludes skin graft donor sites, as they form a specific group of superficial wounds,
which require specific care.

Types of comparison
The following types of comparison were investigated:
Dressing versus no dressing
Topical agent versus no topical agent
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Dressing 1 versus dressing 2
Dressing versus topical agent
Topical agent 1 versus topical agent 2

Search strategy for identification of studies
Details of the general approach to searching are reported in section 5.3 The searches for both
clinical effectiveness studies and health economics reports for this review are given in
Appendix C21. However, in the health economics review, because there were a substantial
number of economic evaluations evaluating debridement we restricted the study design
criteria slightly, and only those studies based on randomised controlled trials and non-
randomised controlled with concurrent controls were included in the review.

Data extraction specific to this review
Details of the type of dressing and topical agents (i.e. locally applied drugs; e.g. antiseptics,
enzymes, etc.) The ideal dressing for healing wounds by secondary intention includes the
following attributes: the ability to absorb and contain exudate without leakage, impermeability
to water and bacteria, lack of particulate contaminants to leave in the wound and the
avoidance of wound trauma on dressing removal (Sharp 2002). The British National
Formulary has classified dressings into categories to aid clinicians in selecting appropriate
products (BNF 2005). This review uses the same categories to organise the material
(Appendix 1). Different types of topical agents are also described in this appendix.

Characteristics of clinical studies included in the review (Appendix D21)
The Cochrane review identified 59 potentially eligible studies, of which 10 RCTs were
included (Cannavo 1998, Eldrup 1985, Goode 1979, Guillotreau 1996, Macfie 1980, Meyer
1997, Schmidt 1991, Vigier 1999, Walker 1991, Young 1982). The update by the NCC
identified 20 potentially eligible new studies, only two of which was included in the review
(Shackleford 2002; Okeniyl 2005). In addition, one of the studies excluded in the Cochrane
review (Dawson 1992) was included in this review: this was stated to be a clinical controlled
trial (i.e. not randomised), but examination of the report revealed randomisation did take
place. Reasons for exclusion of studies are listed in Appendix F21.

563 patients were included in the 13 trials. Eight studies had between 20 and 50 participants
(Cannavo 1998, Dawson 1992, Eldrup 1985, Goode 1979, Meyer 1997, Okeniyi 2005,
Schmidt 1991, Shackelford 2002), five had between 50 and 100 (Guillotreau 1996, Macfie
1980, Vigier 1999, Walker 1991, Young 1982).

Five studies were conducted in the UK (Dawson 1992, Goode 1979, Macfie 1980, Walker
1991, Young 1982); the rest were carried out in Australia (Cannavo 1998), Denmark (Eldrup
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1985),), France (Guillotreau 1996, Vigier 1999), Germany (Meyer 1997), Nigeria (Okeniyi
2005) and USA (Schmidt 1991, Shackelford 2002). All studies but one (Okeniyi 2005) were in
adults, which was in children, and all studies were of parallel group design.

Three studies recruited patients with pilonidal sinuses after incision or excision; two of these
had some patients with infections/abscesses (Eldrup 1985, Walker 1991) and one had all
patients with infected wounds (Guillotreau 1996). Six trials described patients with
postoperative wound breakdown (Cannavo 1998, Goode 1979, Macfie 1980, Schmidt 1991,
Shackelford 2002, Young 1982); three studies included at least some patients with surgical
incision of an abscess (Dawson 1992 (all patients), Okeniyi 2005 (all patients), Meyer 1997),
and one included patients with below knee amputation wounds (Vigier 1999). The GDG
decided the Vigier study was not relevant to the review.

One study included in the review had three comparison arms (Cannavo 1998) Thus there
were 15 comparisons overall.

The following types of comparison were investigated:

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Comparison of conventional dressings
Gauze plus pad versus pad alone: one study (Cannavo 1998)

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Modern versus conventional dressings
Foam versus gauze: four studies (Eldrup 1985; Macfie 1980; Meyer 1997;Walker 1991)
Dextranomer beads versus gauze: one study (Goode 1979)
Alginate versus gauze: three studies, four comparisons (Cannavo 1998 (2), Dawson 1992,
Guillotreau 1996)

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Comparison of different modern dressings
Silicone foam versus dextranomer beads: one study (Young 1982)

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Comparison of topical agents
Aloe vera gel versus placebo gel: one study (Schmidt 1991)
Topical recombinant human platelet-derived growth factor BB gel versus placebo gel
(Shackelford 2002)

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Dressing versus topical agent
Eusol-soaked gauze versus honey: one study (Okeniyi 2005)

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There were further differences within these categories. More specifically the comparisons
were:

Foam versus gauze
Foam versus antiseptic gauze
Silicone foam elastomer (in-situ polymer) versus ribbon gauze soaked in
mercuric chloride antiseptic solution (Macfie 1980)
o The GDG decided that this study should be excluded from analysis as
mercuric chloride antiseptic solution is not used within the UK
Silicone foam elastomer (in-situ polymer) versus gauze soaked with chloramine
(Eldrup 1985)
Silicone foam elastomer (in-situ polymer) versus half strength Eusol-soaked
gauze (Walker 1991)
Foam versus unreported solution
Polyurethane foam containing hydroactive particles versus cotton gauze
soaked with an unreported solution and covered by a simple surgical dressing
(Meyer 1997)

Alginate versus gauze
Alginate (cavity pack or flat dressing) versus combine dressing pad alone (cotton
wool and gauze) (Cannavo 1998)
Alginate (cavity pack or flat dressing) versus gauze (cavity pack or flat dressing)
moistened with sodium hypochlorite (0.05%) with a combine dressing pad (cotton
wool and gauze) (Cannavo 1998)
Calcium alginate rope versus gauze packing soaked with povidone iodine (Guillotreau
1996)
Calcium alginate cavity pack versus gauze packing soaked with saline (Dawson
1992)

Outcomes: All included studies measured wound healing, however different measures were
used. Pain was also measured in different ways. No studies recorded quality of life, but two
reported patient satisfaction (Cannavo 1996, Eldrup 1985).

Characteristics of studies included in the health economic review
(Appendix D21)
Seven published studies were identified in the review (Cannavo 1998, Culyer 1983, Culyer
1984, Goode 1979, Moore 2000, Moore 2001, Walker 1991). However, two economic
evaluations were presented twice in separate publications (Culyer 1983, Culyer 1984, Moore
2000, Moore 2001). For the purpose of this review the economic evaluation will be referenced
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according to the latest publication (Culyer 1984, Moore 2001). In addition one further
economic evaluation (Beiersdorf 2000) was identified which was submitted as part of
company submission data presented to NICE for the NHS Health Technology Assessment
(HTA) report A rapid and systematic review of the clinical effectiveness and cost-
effectiveness of debriding agents in treating surgical wounds healing by secondary intention.

Of these studies, three were also included in the clinical review (Cannavo 1998, Goode 1979,
Walker 1991). Culyer 1984, although not included in the clinical review, was based on
effectiveness data from Macfie 1980, which was also included in the clinical review.
Beiersdorf 2000, although not included in the clinical review, was based on effectiveness data
from Meyer 1997, which was also included in the clinical review. Beirsdorf (2000) used a
decision analytic model to compare the cost-effectiveness in the UK of polyurethane foam
containing hydroactive particles (hydrocolloid dressings) with moist cotton gauze in patients
with a deep secondary healing wound after abdominal surgery.
One further study was also included in the health economics review (Moore 2001).

Using a randomised trial undertaken in the UK, Moore and Foster (2001) compared the
clinical and economic consequences of modern hydrofibre dressings and ribbon gauze in
combination with proflavine dressings in patients with acute surgical wounds left to heal by
secondary intention.

Methodological quality of included clinical studies (Appendix E21)
The method of randomisation was reported in three studies, of which all were classified as
adequate (Goode 1979, Schmidt 1991, Shackelford 2002). The rest of the studies did not
state the method of randomisation.

Allocation concealment was reported in three studies, of which an adequate or partially
adequate method was described in all (Cannavo 1998, Goode 1979, Shackelford 2002
(adequate). It was unclear in the rest of the studies.

Blinding of the outcome assessors was carried out in three studies (Cannavo 1998, Goode
1979, Shackelford 2002). In two (Macfie 1980, Schmidt 1991) the outcome assessors were
not blinded, and in the rest blinding was not stated.

There were no withdrawals in four studies (Dawson 1992, Goode 1979, Meyer 1997, Okeniyi
2005). In three studies the loss to follow up was less than 20% in any group (Macfie 1980,
Shackelford 2002, Vigier 1999) and in one study (Cannavo 1998) the loss to follow up was
30% in one group, but its results were reported with a third group and the combined groups
had less than 20% loss. One study had had 60% missing in one of the groups (Schmidt
1991). The rest of the studies did not state withdrawals.
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Only two studies (Shackelford 2002, Cannavo 1998) reported an a-priori sample size power
calculation. In the former, there were still only 24 randomised patients (22 was calculated to
be the required minimum sample size). The other study (Cannavo 1998) carried out a power
calculation, but the required number of patients were not recruited because of changes in
operating theatre management.

Five studies (Goode 1979, Macfie 1980, Shackelford 2002, Vigier 1999, Young 1982)
reported that the baseline characteristics were comparable, five studies did not report this
(Eldrup 1985, Guillotreau 1996, Meyer 1997, Okeniyi 2005, Walker 1991,). Three studies
reported comparability for some characteristics but differed in others: Cannavo 1998 (wound
volume larger in groups 2 and 3), Dawson 1992 (proportion of perianal/pilonidal abscesses),
Schmidt 1991 (larger wound area for the aloe vera group in the transverse incision group).

The risk of bias was assessed for each included study and one study was assessed as being
at high risk of bias (Schmidt 1991) because of the high loss to follow up (60% in one group)
and lack of baseline comparability. It was decided not to include this study in the analysis.
One study was regarded to be of medium bias Cannavo 1998 (larger initial volume in groups
2 and 3) and this was examined in a sensitivity analysis.

Methodological quality of included health economic studies (Appendix
E21)
On the whole, included studies tended to have a small sample size (median: 42 participants)
and the majority suffered from methodological flaws as reported in Appendix C21. In the
majority of studies, the randomisation procedure and blinding was not reported, and very few
reported the initial wound size, or showed patient groups to be comparable in terms of initial
wound size or wound type.

Regarding the costing methods, Goode 1979 only included dressing costs and ignored other
costs such as nursing time or community nursing visits. The costing studies by Beiersdorf
2000, Moore 2001 and Walker 1991 were more comprehensive including other healthcare
costs such as nurse time changing dressings, duration of in-patient stay, and/or district nurse
visits. However, Beiersdorf 2000 used two sources with very small sample sizes (1 and 5
patients), and provided no information on how these were combined.





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Results 1
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Comparison of conventional dressings

Gauze plus pad versus pad alone

One study compared a gauze moistened with sodium hypochlorite solution (0.05%), followed
by normal saline (0.09%) when the wound was granulating, with a combine dressing pad
versus a combine dressing pad alone (cotton wool and gauze).

Primary outcome wound healing
Wound healing was expressed as a reduction in wound size, in cm/day and cm/day, and for
both, the % change was calculated (Figure 1). A small statistically significant difference in the
percentage wound size reduction was found, favouring the pad alone, e.g. for the volume
reduction, mean difference (volume) = -3.20% (95%CI -4.45, -1.95).

Figure 1: wound healing (wound size reduction)
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Secondary outcomes
Pain
Pain was measured on a VAS (assumed to be 10 point) 30 to 60 minutes after the first
dressing change of the day and then at weekly intervals. Only the maximum pain was
reported (Figure 2). This showed statistically significantly more pain for the gauze plus pad
group; mean difference = 2.30 (95%CI 1.72, 2.88)

Figure 2: Maximum pain on VAS
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Patient satisfaction
Patient comfort was assessed using a questionnaire with a 10 point rating scale during
dressing changes and between dressing changes in the first week and at the last visit.
Patients in the antiseptic gauze plus pad group were significantly less satisfied than those in
the pad only group in the first week, but significantly more satisfied at the last visit (Figure 3).
All differences were small, especially at the later visit.

Figure 3: Patient satisfaction
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Cost-effectiveness
One study (Cannavo 1998) compared the cost-effectiveness of a gauze moistened with
sodium hypochlorite solution (0.05%), followed by normal saline (0.09%) when the wound
was granulating, with a combine dressing pad versus a combine dressing pad alone (cotton
wool and gauze).

The results found that the mean total cost per day in patients receiving the pad alone was
lower than for those receiving gauze plus pad (A$14.14 vs. A$19.36, respectively). However,
it is unclear if this difference was statistically significant.

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Modern versus conventional dressings
Foam versus gauze

Four studies compared foam with gauze: in three cases the gauze was soaked with an
antiseptic solution and the other study had an unreported solution. In the first three studies
the foam was formed by in-situ polymerisation from a silicone elastomer and a catalyst. One
of these studies was a within-study subgroup (Walker 1991), without prior stratification (i.e.
groups may not be comparable). The comparison with the gauze soaked with the unreported
solution was with a polyurethane foam containing hydroactive particles.

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Primary outcome wound healing
The silicone foam gauze comparisons (Eldrup 1981, Walker 1991) reported the outcome as
wound healing, but neither of these reported standard deviations. The authors of both of
these studies reported no significant difference between any groups. Since both of these
studies used different antiseptic solutions to soak the gauze, it is unclear if differences
between studies should be attributed to the type of solution. Overall there is insufficient
evidence to determine if there is a difference in wound healing between silicone foam and
gauze.

The other study (Meyer 1997) investigated wound healing as the reduction in wound size over
four weeks. The authors reported a statistically significantly greater reduction in wound size
for the polyurethane foam with hydroactive particles compared with the moistened gauze
(75.6% reduction versus 50.1%). However, the Cochrane review also reported an almost
significant (p=0.07) proportion of wounds completely healed in the foam group at 4 weeks
compared with gauze; RR 2.62 (95% CI 0.97, 7.07). It is not clear if the hydroactive particles
contributed to the improved wound healing.

Secondary outcome measures

Pain
One study (Meyer 1997) reported patients' levels of pain at week 4 using a 10-point visual
analogue scale (higher score indicating more pain) and reported a small but statistically
significant difference (p < 0.05) indicating more pain with the gauze dressing (mean score
1.82) compared with polyurethane foam (0.86).

Patient satisfaction
Eldrup (1985) stated that the foam dressing was more comfortable to patients but reported no
data.

Hospitalisation period
Hospitalisation period was reported in one study (Walker 1991). The authors reported that
they did not find a statistically significant difference between the foam and gauze groups
(pilonidal abscess: average length of stay was 11.5 days for foam compared to 14.6 days for
gauze), but standard deviations were not reported.

District nurse visits
Eldrup (1985) reported the same number of district nurse visits for both dressing groups, but
reported no standard deviations.

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Complications and morbidity
Complications and morbidity were reported in one study. Meyer (1997) reported no cases of
necrotic tissue, odour, putrid secretion and/or itching.

Cost-effectiveness
Two studies (Culyer 1984, Walker 1991) compared the cost-effectiveness of silicone foam
elastomer with conventional moist gauze dressings.
Culyer 1984 found that patients receiving the foam elastomer dressing required significantly
fewer district nurse visits, experienced less pain, and for a variety of scenarios, the cost per
case for foam elastomer dressings were lower than for conventional dressings. Results from
Walker 1991 showed that for patients in the abscess group receiving the foam elastomer
dressing were found to be discharged on average three days earlier than those treated with
conventional dressings (although this was not statistically significant). The authors also
reported that by using foam elastomer dressings, an average total saving of 500 per patient
could be made resulting due to decreased hospitalisation, and less community nurse visits.

One further study (Beiersdorf 2000) investigated the cost-effectiveness of polyutherane foam
dressings compared to traditional gauze dressings. Beirsdorf 2000 found that patients
receiving polyutherane foam dressings would need fewer dressing changes, and that the
dressing time per wound was shorter in this group. As a result, the authors found that treating
patients with polyutherane foam dressings saved from 5-20 per week for each patient
treated.

Bead versus gauze

Goode 1979 compared dextranomer beads with Eusol soaked ribbon gauze in a small study
with 10 patients in each group. Patients had open, infected surgical wounds after
appendectomy or bowel surgery.

Primary outcome - wound healing
The study reported the time to secondary wound closure, this being carried out when the
wounds were clean and granulation tissue was forming. The authors reported that the mean
time to wound closure was significantly shorter for the dextranomer group (8.1 days versus
11.6 days; p<0.05). In view of the small size of the study, this study was treated cautiously.

Secondary outcomes

Hospitalisation period
Goode 1979 reported that the patients treated with bead dressing had a shorter hospital stay
by a median of 2.2 days. No data or statistics are given.
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Cost-effectiveness
One study (Goode 1979) compared the cost-effectiveness of dextranomer polysaccharide
beads with traditional gauze dressings soaked with Eusol.

The cost of the dextranomer polysaccharide beads for the twice daily dressing of a 10cm
wound was higher, being approximately 3.40, than for the gauze dressing however, the
authors suggest that potentially this high cost was compensated for by a saving in the total
cost of hospital care resulting from the shorter hospital stay.

Alginate versus gauze

Three studies compared alginate and gauze dressings: Cannavo 1998 compared alginate
with sodium hypochlorite moistened gauze plus a combine dressing pad (this study reported
differences in the initial wound volume between the two groups). Guillotreau 1996 (a
conference abstract) compared calcium alginate rope with povidone iodine soaked gauze
packing. Dawson 1992 compared calcium alginate cavity pack with gauze packing soaked
with saline.

Primary outcome - wound healing
The studies reported wound healing in different ways. In Guillotreau 1996 and Dawson 1992,
healing was reported as the proportion of wounds completely healed during a two, three or
four week follow-up period (Figure 4). The Guillotreau study had too much uncertainty to draw
conclusions, and the Dawson study showed little difference between interventions.

The Cannavo study measured changes in wound surface area/day and volume/day. For both,
the % change was calculated. There was a statistically significantly greater percentage
reduction in both mean surface area and mean volume for the alginate group compared with
the hypochlorite soaked gauze plus combine pad group. The mean difference for the volume
is small: 1.30% (95%CI 0.05, 2.55). However, it should be noted that the initial volume for the
gauze group was larger (19.4 cm
3
versus 14.9 cm
3
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Figure 4: Wound healing
a) Proportion of wounds healed
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Overall there was insufficient evidence to decide if there was a difference in wound healing
between alginate and gauze.

Secondary outcomes

Pain
All studies measured pain using a 10-point VAS scale.
Cannavo 1998 measured pain, 30 to 60 minutes after the first dressing change of the day and
subsequently at weekly intervals. Only the maximum pain score was reported. Calcium
alginate caused significantly less pain (mean score 2.5 0.65 on 10-point VAS scale) than
antiseptic gauze with combine pad (mean score 5.2 0.740).
The mean difference was: -2.7 (95%CI: -3.28, -2.12).
Dawson 1992 reported individual pain scores (0-10) on changing the dressing on the first
postoperative day. The mean and standard deviation were calculated from individual patient
data extracted from a graph. The calcium alginate dressing resulted in statistically significantly
less pain than the saline soaked gauze. Mean difference was: -2.86 (95%CI -4.61, -1.11)

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1 Figure 5: pain on removal of dressing


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Guillotreau 1996 also used a visual analogue scale and reported that alginate rope was
painless (p=0.0001) compared to PI soaked gauze, but no group data were given.

Ease of use/removal
The Guillotreau study reported that the alginate rope was statistically significantly easier to
use (p=0.011) compared to PI soaked gauze, but no group data were given. The Dawson
study reported ease of removal scores (0-10; 10 most difficult) as assessed by the nurse on
changing the dressing on the first postoperative day. The mean and standard deviation were
calculated from individual patient data extracted from a graph (Figure 6). The saline soaked
gauze was statistically significantly more difficult to remove than the calcium alginate
dressing. Mean difference was: -3.07 (95%CI -4.49, -1.65)

Figure 6: Difficulty of removal of dressing
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Patient satisfaction
Cannavo et al 1998 assessed patient comfort using a questionnaire with a 10 point rating
scale during dressing changes and between dressing changes in the first week and at the last
visit. Patients in the antiseptic gauze plus pad group were significantly less satisfied during
and between dressing changes in the first week than those in the alginate group (Figure 7). It
is noted, however, that these two groups differed in the initial volume of the wound.

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1 Figure 7: patient satisfaction
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Complications and morbidity
In the alginate group of Cannavo 1998, one wound developed a sinus after three weeks,
requiring further surgery and another wound showed over-granulation after three weeks. In
the antiseptic gauze group two patients developed a sinus after two weeks, of which one
required further surgery.

Cost-effectiveness
One study (Cannavo 1998) compared the cost-effectiveness of alginate dressings with
sodium hypochlorite moistened gauze plus a combine dressing pad.

The results found that the mean total cost per day in patients receiving alginate dressings was
lower than those in the sodium hypochlorite group (A$15.25 vs. A$19.36, respectively;
p=0.069).

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Comparison of different modern dressings

Foam versus dextranomer beads

One study (Young 1982) compared silicone foam and dextranomer bead dressings in 50
patients with surgical wounds that had either broken down or had been left open
postoperatively.

Primary outcome measure - wound healing
There was insufficient evidence to determine if there is a difference between foam and bead
in the time to complete healing.


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1 Figure 8: time to healing
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Secondary outcomes

Pain

There was no significant difference in the mean time to become pain free (narrow confidence
interval).

Figure 9: Time to pain free state (days)
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Complications and morbidity
Whilst Young (1982) stated that there was no difference between the groups in the time taken
for disappearance of erythema, oedema and slough, no data were provided.

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Comparison of topical agents

Topical recombinant human platelet-derived growth factor BB gel versus placebo gel

Shackelford (2002) randomised 24 patients with separated abdominal surgical wounds after
caesarean section or benign gynaecological abdominal procedures to topical recombinant
human platelet-derived growth factor BB gel or placebo gel. The authors stated that they had
problems of recruitment to the study, which was due to a lower than expected wound
complication rate (2.4%). They also said that the results are to be considered preliminary
only. Of 1065 qualifying operations, only 26 were suitable participants and 24 agreed to
participate.

Primary outcome - wound healing
Number of treatment days: Patients in the treatment group received 29 days 14 days of
treatment and patients in the comparison group received 47 24 days treatment (P=0.057).
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The mean difference was: -18.00 (95%CI: -33.72, -2.28), i.e., statistically significantly shorter
for the treatment group.
The wounds of the patients in the treatment group closed 35 15 days after the operation (i.e.
healed). The wounds of the comparison group closed 5426 days after the operation
(p=0.05). The mean difference was: -19.00 [-35.98, -2.02], i.e. statistically significantly in
favour of the treatment group.
The authors reported that wounds in the treatment group closed more rapidly those in the
comparison group as determined by Kaplan-Meier analysis. These results were of borderline
significance (p=0.05).

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Dressing versus topical agent

Eusol-soaked gauze versus honey

One Nigerian study compared Eusol soaked gauze with honey in 32 children following
incision and drainage of abscesses

Primary outcome wound healing
The times to cleanness (absence of sloughs and exudates) and the presence and completion
of epithelisation were reported (Figure 10). There was statistically significantly more patients
in the honey group with wounds that were clean and dry, and that had granulation tissue at
seven days. There was statistically significantly more wounds with complete epithelisation at
21 days for honey.

Secondary outcome

Length of hospital stay

The group receiving honey had a statistically significantly shorter stay in hospital compared
with patients receiving Eusol soaked gauze. Mean difference: 2.53 (95%CI 0.59, 4.47).
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1 Figure 10: Wound healing
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Figure 11: length of stay
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Cost-effectiveness discussion
The results of this review suggest that modern dressings are cost-effective compared with
traditional gauze dressings in the management of surgical wounds healing by secondary
intention as they are generally associated with lower overall costs and are also likely to be
more acceptable to patients and reduce pain.

No study included in the review compared the relative cost-effectiveness between the
different types of modern dressings. In the NICE Technology Appraisal Guidance no. 24,
NICE concludes that in the absence of sufficient evidence of differences in effectiveness,
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either in terms of time to heal wounds or patient acceptability, it would be appropriate to use
cost minimisation as the basis of choice between modern dressings. This approach must take
into account the total costs of wound care treatment particularly frequency of dressing
changes and not the unit costs of the debriding agent alone.

The same guidance also concluded that there is the need to investigate the range of
methods of debridement. This should use appropriate research methods, particularly
randomised controlled trials and rigorous observational designs. [] Methodologically robust
cost effectiveness studies should be carried out, either as part of, or based upon the
effectiveness data of studies proposed.

GDG consensus
The GDGs consensus was that clinicians should consider the total cost of wound care, the
frequency of dressing change and the patient experiences.
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Evidence statements and recommendations 1
2
Level of
evidence
Evidence statements
1+

1+

HE
For dirty or infected wounds healing by secondary intention, there was fair
evidence to show a small statistically significant decrease in wound healing, for
an antiseptic soaked gauze plus a combine pad compared with a pad alone.
There was also significantly more pain, and less patient satisfaction for dressing
changes in the first week, for the gauze plus pad group.
There is limited evidence that for infected or dirty wounds healing by secondary
intention the use of an antiseptic soaked gauze plus a combine pad was more
costly than a pad alone.
Furthermore, as the antiseptic soaked gauze plus a combine pad was found to be
less effective in wound healing and caused more pain and less patient
satisfaction, this intervention is highly unlikely to be cost-effective.
1+

1+

HE
For dirty or infected wounds healing by secondary intention, there was fair
evidence to show a statistically significantly greater decrease in wound size for
polyurethane foam with hydroactive particles compared to moistened gauze.
There was also a small statistically significant difference indicating more pain with
the gauze dressing compared with polyurethane foam.
There was limited evidence that for infected or dirty wounds healing by secondary
intention use of polyurethane foam with hydroactive particles was associated with
a reduction in frequency in dressings changes and staff time needed to change a
dressing when compared to gauze. As a result, polyurethane foam was found to
be less costly than gauze.
Furthermore, as polyurethane foam was found to be more effective in wound
healing and caused less pain for patients, this intervention is highly likely to be
cost-effective.
1-

HE
For dirty or infected wounds, there is weak evidence in a small study to suggest
that wound healing is significantly better for dextranomer beads compared with
Eusol soaked gauze.
There was weak evidence that for dirty or infected wounds healing by secondary
intention, that the additional consumable costs of dextranomer beads over Eusol
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soaked gauze would be offset by savings due to shorter hospital stay.
1-

1+

1-
For dirty or infected wounds healing by secondary intention, there is insufficient
evidence in three studies to determine if there is a difference between alginate
dressing and gauze.
There is fair evidence to show that the alginate gave statistically significantly less
pain on dressing change and was easier to use than the gauze dressing.
There is insufficient evidence to decide if there is an effect on patient satisfaction
with alginate dressing or gauze.
There was insufficient evidence to decide if alginate dressings were less costly
than gauze for dirty or infected wounds healing by secondary intention.
1-

1+
For dirty or infected wounds healing by secondary intention, there is insufficient
evidence in three studies to determine if there is a difference between silicone
foam and dextranomer bead dressings.
There was no significant difference between foam and bead dressings in the
mean time to become pain free.
1- For dirty or infected wounds healing by secondary intention, there is insufficient
evidence in a preliminary trial to determine if there is a difference in wound
healing between topical recombinant human platelet-derived growth factor BB gel
and placebo gel.
1+ For dirty or infected wounds healing by secondary intention, there was fair
evidence to show a statistically significant decrease in wound healing after four
days, and a significantly shorter hospital stay, for children treated with honey
compared with a Eusol soaked gauze dressing.
1

Grade

Recommendation
D For surgical wounds healing by secondary intention a modern interactive dressing
should be used. Foam, alginate and hydrocolloid dressings should be considered
as first-line treatments.

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6.22 Dressings and Topical Agents for Surgical Wounds
Healing By Secondary Intention Part II: Toenail Avulsion
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Introduction
This review looks at dressings and topical agents for surgical wounds healing by secondary
intention, and focuses on toenail avulsion. It is an update of part of the Health Technology
Assessment (HTA) report, A rapid systematic review of the clinical and cost effectiveness of
debriding agents in treating surgical wounds healing by secondary intention. The rest of the
HTA report is covered in section 6.21. This review presents both clinical and cost
effectiveness evidence.

Objectives
To determine the clinical and cost-effectiveness of various dressings and topical agents for
the healing of the surgical sites following toenail avulsion.

Criteria for considering studies for this review
Types of participants
All patients undergoing toenail surgery where a visible wound is purposely left to heal by
secondary intention.
Types of comparison
The following types of comparison were searched for:
Dressing versus no dressing
Topical agent versus no topical agent
Dressing 1 versus dressing 2
Dressing versus topical agent
Topical agent 1 versus topical agent 2

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for
both clinical effectiveness studies and health economics reports for this review are given in
Appendix C22.

Data extraction specific to this review
Details of the type of dressing and topical agents (i.e. locally applied drugs; e.g. antiseptics,
enzymes, etc).



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Characteristics of clinical studies included in the review (Appendix D22) 1
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The search identified 12 potentially eligible studies, of which three were included (Denning
2003, Dovison 2001and Foley 1994). Reasons for exclusion of studies are listed in Appendix
D22.

206 patients were included in the three studies. Study size ranged from 42 to 94. Two studies
were conducted in the UK (Denning 2003 and Foley 1994); and one was carried out in
Australia (Dovison 2001). All studies included adults, but two also contained children and the
other did not say (Dovison 2001). All studies were of parallel group design, but one study
(Denning 2003), reported that the 94 patients underwent 123 procedures, but did not state if
patients or procedures were randomised.

One study included in the review had three comparison arms (Dovison 2001), resulting in 5
comparisons overall. The following types of comparison were found:
Dressing versus no dressing
Povidone iodine dressing (Inadine) plus dry dressing (Release) versus dry
dressing alone (Denning 2003).
10% Povidone iodine with paraffin gauze versus paraffin gauze alone
(Dovison 2001)
Hydrogel with paraffin gauze versus paraffin gauze alone (Dovison 2001)

Dressing 1 versus dressing 2
Calcium sodium alginate dressing (Kaltostat) versus non adherent, dry
dressing (Melolin) (Foley 1994)
Povidone iodine with paraffin gauze versus amorphous hydrogel with paraffin
gauze (Dovison 2001)

Two studies were carried out in patients having both partial and total nail avulsions; in the
other study (Dovison 2001) all patients had partial nail avulsion.
All included studies measured wound healing in days. In the Denning study, wound healing
was reported by the patient, using a diary. Healing was recorded if there was no exudate. In
the Dovison study, healing was defined as complete re-epithelialization of the wound; no
evidence of pink translucent tissue; no exudates; no erythema; no infection. The Foley study
reported that their criteria for healing included: no signs of infection; no pain or tenderness; no
exudate; surgical site dry; re-epithelialization; no swelling; no inflammation; no irritation;
normal sensation.
One study (Foley 1994) reported the number of dressing changes and the patients were
asked to assess the dressings for comfort, acceptability and pain on dressing removal.

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Characteristics of studies included in the Health Economic review
(Appendix D22)
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One study was included in the cost-effectiveness review (Foley 1994), which was also
included in the clinical review.

Methodological quality of included clinical studies (Appendix E22)
The method of randomisation was poorly described in one study (Denning 2003), which we
classified as unclear: the authors described the study as randomised, but said that the
patients were allocated their appointment for surgery by computerised appointment
scheduler. Patients undergoing surgery on Tuesdays were allocated to the control group and
those on Thursdays to the treatment group. The rest of the studies did not state the method of
randomisation.

Allocation concealment was not described in any of the studies.

Blinding of outcome assessors was inadequate in one study (Denning 2003) and unclear in
the other studies.

No details of a power calculation were described in the included studies, and the baseline
comparisons across each study showed no significant differences.

One study (Denning 2003) reported that many patients did not attend the final redressing
appointment. The other studies had a loss to follow up of 25% in one of the groups (Dovison
2001) or no withdrawals (Foley 1994).

The risk of bias was assessed for each included study and none were assessed as being at
high risk of bias. The Denning study was regarded as medium risk because many patients
dropped out. This study was therefore regarded with caution.

Methodological quality of health economic evidence (Appendix E22)
Foley 1994 suffered from some methodological weaknesses, with the authors not reporting if
patient groups were comparable on baseline wound size, possibly biasing the results. The
analysis of costs only included consumable dressing costs, and did not include other relevant
costs such as frequency of dressing changes or the number of healthcare professional visits.





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Results 1
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Dressing plus secondary dressing versus secondary dressing alone

Primary outcome wound healing

Povidone iodine plus secondary dressing versus secondary dressing alone

Two studies compared a povidone iodine dressing plus a secondary dressing with a
secondary dressing alone. The two comparisons were dissimilar the Denning study used a
PI dressing with a dry, absorbent dressing (Release); and the Dovison study used 10% PI
with paraffin gauze.
Both studies reported the time to healing. Figure 1 shows there is insufficient evidence in the
Denning study (wide confidence interval); mean difference -6.60 days (-15.12, 1.92) and little
difference between interventions in the Dovison study; mean difference 0.10 days (95%CI -
4.83, 5.03). Overall, there is insufficient evidence to determine whether there is a difference in
wound healing between a povidone iodine dressing with a secondary dressing compared to a
secondary dressing alone.

Figure 1: dressing plus secondary dressing versus secondary dressing alone time to
healing
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Amorphous hydrogel versus no dressing

One study (Dovison 2001) compared amorphous hydrogel with a paraffin gauze versus
paraffin gauze alone (Figure 1). The GDG, however, regarded this study to have a poor study
design the hydrogel would be displaced by the top dressing and therefore this comparison
was not included in the analysis.

Dressing 1 versus dressing 2

Alginate dressing versus dry dressing

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One study (Foley 1994) compared calcium sodium alginate dressing (Kaltostat) with an
absorbent, dry dressing (Melolin). Both arms had a secondary dressing of gauze plus
tubegauze.

Primary outcome wound healing
There was a statistically significant increase in wound healing for the alginate group (Figure
2). Mean difference: -8.60 days (95%CI: -15.20, -2.00).

Figure 2: wound healing
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Secondary outcomes
Dressing changes
There were fewer dressing changes in the alginate group (figure 3);
mean difference -0.90 (95%CI -1.84, 0.04), although this was not statistically significant
(p=0.06).

Figure 3: number of dressing changes
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Patient related outcomes
The study also reported that differences between groups were not significant for patient
comfort, pain on dressing removal and acceptability of the dressing.

Cost-effectiveness
One study (Foley 1994) compared the costs and effects of calcium sodium alginate flat
dressings with cotton and acrylic fibre pad bonded to perforated low-adherent polyester film.

Results from this study showed that patients in the calcium sodium alginate dressings group
required a significantly lower number of dressing changes (p<0.05). The authors also reported
that the additional dressing cost of the calcium alginate dressings was between 1.60 and
2.20 per patient in the study, and that the reduction in healing time due to these dressings
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represented a saving of one or two clinic appointments. Although the study found that calcium
alginate dressings were more expensive than cotton and acrylic fibre pads, these costs will
probably be offset by the savings generated by fewer clinic appointments.

10% Povidone iodine with paraffin gauze versus amorphous hydrogel with paraffin gauze

One study (Dovison 2001) compared 10% PI with an amorphous hydrogel; each had a
secondary paraffin gauze dressing. As mentioned above, the GDG regarded the study design
for this comparison to be flawed. Thus this was not included in the analysis.

Evidence statements and recommendations

Level of
evidence
Evidence statements
1-

There was insufficient evidence to determine whether there is a difference in
wound healing between a povidone iodine dressing with a secondary dressing
compared to a secondary dressing alone.
1+



1-


HE
There was fair evidence to show a statistically significant increase in wound
healing and significantly fewer dressing changes for an alginate dressing
compared with a non-adherent, highly absorbent, dry dressing.

The study stated that patients reported no significant differences in their comfort,
pain on dressing removal and acceptability of the dressing, but data were not
given.
There was some evidence to suggest that the additional costs of alginate
dressings over non-adherent, highly absorbent, dry dressings would be offset by
savings in fewer dressing changes and fewer clinic visits.
13
14



Grade

Recommendations
A Following toenail avulsion an alginate dressing (a modern interactive dressing)
should be used instead of gauze.
D Other modern interactive dressings can also be considered with an appropriate
secondary dressing, as clinically indicated.
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6.23 Pinsite Care 1
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Introduction
This review is an update of a Cochrane review, Pin site care for preventing infections
associated with external bone fixators and pins. The Cochrane Database of Systematic
Reviews 2004 (Temple and Santy, 2004).

Objective
To evaluate the effects of various pin site management techniques, including cleansing,
massage and dressing, on postoperative surgical site infection (SSI) rates.

Criteria for consideration for this review

Types of comparison
The following types of comparisons were considered for inclusion:
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Cleansing Solutions
cleansing versus no cleansing
cleansing solution 1 versus solution 2 (e.g. sterile normal saline, alcohol
solutions, iodine solutions, cooled boiled water or ordinary tap water)
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Methods of cleansing
Method 1 versus method 2 (e.g. sterile technique versus a non-sterile technique)
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Primary dressing
Primary dressing versus no dressing
Primary dressing 1 versus dressing 2 ((e.g. no dressing versus any dressing;
comparisons between dressings)
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Massage
Massage versus no massage
Massage 1 versus massage 2 (e.g. different massage regimens; the
management of 'skin-tenting' around pins)
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Frequency of pin site care
Frequency 1 versus frequency 2
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Comprehensive treatment regimens
Regimen 1 versus regimen 2 (e.g. Kurgan Ilizarov method)

Studies of treatment regimens that set out to manage established infections were not
included.



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Data extraction specific to this review 1
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In addition, to incidence of infection, frequency of pin re-siting due to infection, frequency of
external fixator apparatus removal due to infection, patient comfort and patient acceptability
were also considered.

Characteristics of the included studies in the clinical effectiveness
review (Appendix D23)
Two studies were identified that were suitable for inclusion, one in the Cochrane review
(Henry 1996) and one in the update (W-Dahl 2003). Both trials had SSI rate as the primary
outcome.

The two studies included 40 patients in total, with 160 pins; one study was in adults (W-Dah
2003) and the other in children (Henry 1996). In the Henry study, patients were undergoing
leg lengthening surgery and in the W-Dahl study patients had surgery for gonarthrosis by the
hemicallotasis technique.

The following comparisons were investigated:
Cleansing versus no cleansing (Henry 1996)
Cleansing with solution 1 versus solution 2 (Henry 1996)
0.9% saline versus 70% alcohol
Cleansing frequency 1 versus frequency 2 (W-Dahl 2003)
effect of a daily versus weekly pin site care protocol on infection rates.

Henry 1996 defined infection as pain, redness and swelling and a significant number of
pathogenic bacteria on culture at the pin site with or without systemic symptoms. In W-Dahl
2003, the Checketts-Otterburns classification of infections was used for assessment (Table 1,
end of this review).

There were no health economic studies identified.

Methodological quality of included studies
The method of sequence generation was reported and adequate in W-Dahl 2003, but unclear
in Henry 1996. Allocation concealment was unclear in both studies. The W-Dahl study did not
blind the outcome assessors and it was unclear in Henry 1996. Baseline comparability was
indicated in W-Dahl 2003 and was unclear in Henry 1996. All patients completed the studies.

Patients were randomised to interventions, but both studies assessed the effect in each pin,
therefore they were cluster randomised trials.

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The W-Dahl study recorded infections up to six weeks postoperatively, but the time of
assessment was not stated in the Henry study, although the report says the infection rate was
not related to length of time the pin was in place, 56-244 days.

Results

Cleansing versus no cleansing

Primary outcome rate of SSI
The Henry study compared the effect of daily cleansing with 0.9% saline, or with 70% alcohol
or no cleansing on infection rates. All pins had massage to remove crusts and povidone
iodine dry spray and a dry gauze dressing. Each group consisted of 10 patients (40 pins). The
pins were in situ from 56 - 244 days. Henry 1996 noted that the infection rate did not relate to
the length of time the pin was in situ and that once an infection had occurred it would often
recur at a later stage at the same pin.

Analysis showed wide confidence intervals in the separate comparisons of saline or alcohol
with no cleansing, and also in the combined cleansing versus no cleansing comparison
(Figure 1). There was borderline significance (p=0.05) for the saline versus no saline
comparison, favouring no daily cleansing. In view of the lack of information on the time
infections were measured, in addition to the wide confidence intervals, it was concluded that
there is too much uncertainty in this study to determine if there is any effect of daily cleansing
on rates of SSI.

Figure 1: daily cleansing versus no cleansing rate of infection in pins
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Daily cleansing with solution 1 versus solution 2

Primary outcome rate of SSI
The Henry study compared the effect of daily cleansing with 0.9% saline versus 70% alcohol
on infection rates.
There was insufficient information (wide confidence interval) to determine if there is a
difference in rate of infection between saline and alcohol for daily cleansing.

Figure 2: daily cleansing with saline versus alcohol
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Frequency of cleansing 1 versus frequency 2
W-Dahl (2003) investigated the effect of different frequencies of cleansing, using the same pin
site care protocol (crust removal then cleansing with 0.9% saline); weekly cleansing was
compared with daily.

Primary outcome rate of SSI
There was insufficient information (wide confidence intervals) to determine if there was a
difference in SSI rate between daily and weekly pin site care.

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24

In the absence of good quality evidence, GDG consensus was that pin sites should be kept
clean to minimise the risk of infection. This may be achieved through regular assessment,
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3
4
and the weekly removal of dried exudates. Use of low-adherent dressings to cover pin-sites
may be useful for practical reasons e.g. cosmesis or psychological reassurance.

Evidence statements and recommendations
Level of
evidence
Evidence statement
1-



1-
There is insufficient evidence to determine whether daily cleansing with either saline or
alcohol (in addition to initial povidone iodine dry spray and a dry gauze dressing)
affects the rate of SSI at pin-sites associated with leg-lengthening surgery in children.
There is insufficient evidence to determine if there is a difference in SSI rates between
daily saline and alcohol solutions for pin site care in the same groups.

1- There is insufficient evidence to determine whether a daily or weekly pin site care
protocol (crust removal then saline cleansing) affects the rate of SSI in adult patients
undergoing gonarthrosis by the hemicallotasis technique.

4 GDG consensus was that pin sites should be kept clean to minimise the risk of
infection. This may be achieved through regular assessment, and the weekly removal
of dried exudates. Use of low-adherent dressings to cover pin-sites may be useful for
practical reasons e.g. cosmesis or psychological reassurance.

5
6
7




Grade

Recommendation
GPP Pin sites should be kept clean to minimise the risk of infection. This is achieved through
assessment and the weekly removal of dried exudate. Pin sites may be covered with
appropriate dressings.

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2
Table 1: Checketts-Otterburns infection classification system (reproduced from
Holmes 2005)
Grade Appearance Treatment
1 Slight redness, little discharge Improved pin site care
2 Redness of skin, discharge, pain, and
tenderness in the soft tissues
Improved pin site care, oral
antibiotics
3 Grade 2 but not improved with antibiotics Affected pin or pins re-sited
and external fixation can be
continued
4 Severe soft tissue infection involving several
pins, sometimes with associated loosening of
the pin
External fixation must be
abandoned
5 Grade 4 but also involvement of the bone; also
visible on radiographs
External fixation must be
abandoned
6 This infection occurs after fixator removal. The
pin track heals initially but will break down and
discharge in intervals. Radiograph shows new
bone formation and sometimes sequestra.
Curretage of the pin track
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6.24. Treatments for people with surgical site infections 1
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Objective
To determine the clinical and cost effectiveness of treatments for people with surgical site
infections.

Criteria for considering studies for this review

Types of intervention
The following types of interventions were included:
Antibiotics given systemically by any route (oral, intramuscular or intravenous), or
locally as ointments or solutions.
The GDG restricted the antibiotics to those in use in the UK
Solutions including honey, debrisan-dextranomer, tea tree, aloe vera, silver cream or
povidone iodine
Techniques and methods including open drainage, vacuum assisted closure or
another closure technique, maggot debridement, lavage, aspiration, laser or
ultrasound

Types of comparison
The following types of comparison were investigated:
Antibiotic 1 versus antibiotic 2
Solution 1 versus solution 2
Technique 1 versus technique 2
Any other comparison of interventions from the above list
Route of administration 1 versus route of administration 2 for a single intervention

Search Strategy
Details of the general approach to searching are reported in section 5.2. The searches for
both clinical effectiveness studies and health economics reports for this review are given in
Appendix C24.

Data extraction specific to this review
Details of the type of intervention (antibiotic, solution, technique)
Details of the outcomes reported, including method of assessment and time intervals.
Pathogen eradication was not included as a measure for infection cure rates.
A post-hoc decision was made to extract outcome data for the specific subgroup of patients
with a confirmed wound infection, if reported. This was because few of the studies specifically
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enrolled patients with an SSI but enrolled patients with mixed types of infections that
frequently included abscesses, cellulitis and ulcers.

Characteristics of clinical studies included in the review (Appendix D24)
The review identified 314 potentially eligible studies, of which six were included (Al-Waili
1999, Kiani 1991, Korpan 1995, Kraus 1998, Liu 1995, Mallory 1991). Reasons for exclusion
of studies are listed in Appendix F24, but the main reasons were: not an RCT (222); did not
evaluate an SSI (33); prophylaxis of infection rather than acute treatment (16); antibiotic not
available in the UK (13).

A total of 1657 patients were included in the seven studies. No studies were conducted in the
UK; they were carried out in Ukraine (Korpan 1995); United Arab Emirates (Al-Waili 1999)
and USA (Kiani 1991, Kraus 1998, Liu 1995, Mallory 1991). All studies included adults and
one also included young children (Kraus 1998).

Only two of the studies were exclusively in patients with wound infections following surgery
(Al-Waili 1999, Korpan 1995). One study had a population with infected small lacerations,
abrasions or infected wounds (Kraus 1998); one had a population with infected ulcers,
infected wounds, major abscesses or significant underlying diseases such as diabetes and
peripheral vascular disease (Liu 1995); two had a population with abscesses, cellulitis,
impetigo, infected wounds and other skin infections (Kiani 1991 and Mallory 1991). The latter
two studies had only 6 to 9% and 2.5 to 3% wound infections respectively. The GDG decided
to analyse these studies only if results were reported separately for wound infections, but
recognised that SSIs formed a very low proportion of infections in two studies.

No studies in the review had three or more relevant comparison arms. The following types of
comparison were investigated:
Antibiotic 1 versus antibiotic 2: four studies (Kiani 1991, Kraus 1998, Liu 1995,
Mallory 1991)
Solution 1 versus solution 2: one study (Al-Waili 1999)
Technique 1 versus placebo: one study (Korpan 1995)

Different types of antibiotics were used and the specific comparisons were:
Oral azithromycin 500 mg given on day 1 followed by 250 mg days 2 to 5 versus oral
cephalexin 500 mg twice daily for 10 days: two studies (Kiani 1991, Mallory 1991)
iv imipenem-cilastatin 500 mg every 6 hours followed by oral ciprofloxacin 750 mg
every 12 hours versus iv levofloxacin 500 mg every 12 hours followed by the same
dose of oral levofloxacin: one study (Liu 1995)
Comparison of regimens rather than antibiotics
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Topical mupirocin calcium cream (2% mupiricin) three times daily for 10 days versus
oral cephalexin 250 mg four times daily for 10 days (adjusted for body weight): one
study (Kraus 1998)
Two variables changing at once
Thus, the studies compared specific antibiotic combined regimens.

The studies measured rate of healing (either cured or improved), defined in various ways:
three (Kiani 1991, Mallory 1991, Kraus 1998) monitored the resolution of signs of infection
(the former two at 11 days); one did not say how the response was measured (Liu 1995); one
used a clinical subjective assessment (Al-Waili 1999); one used initial epithelisation, wound
clearance, granulation appearance and decrease in wound surface area (Korpan 1995) and
the other measured the decrease in wound surface area.
One study reported pain as an outcome (Korpan 1995). One reported patient preference in
their double dummy trial, but it is unclear how this could be properly assessed (Kraus 1998).

Characteristics of studies included in the Health Economic review
(Appendix D24)
No studies were identified in the health economics review. Results from the clinical review
showed there were no significant differences between antibiotics in terms of clinical response
for antibiotics used to treat surgical site infections. As a result a cost-minimisation analysis
was undertaken for every study comparing one type of antibiotic to another. This analysis only
includes the unit costs of the antibiotic themselves. The dose and duration of treatment was
derived from each study investigating the effectiveness of one antibiotic to another, and the
costs of the antibiotics were derived from the British National Formulary (BNF 2005). The
analysis did not include any other costs, e.g. staff time required to apply the antibiotic.

Methodological quality of included clinical studies
The results of the quality assessment for included trials are shown in Appendix E24.
The method of randomisation was reported in one study (Kraus 1998), which was classified
as adequate. The rest of the studies did not state the method of randomisation. The method
of allocation concealment was unclear in all studies. Three studies reported blinding (Kiani
1991, Korpan 1999, Kraus 1998); in the rest, blinding was not stated.

There were no withdrawals in one study (Al-Waili 1999) and one had 2/31 patients excluded
from the analysis (Liu 1995). No details of the analysis were reported in one study (Korpan
1999), one study (Kraus 1998) stated that about 10% of patients did not complete the study,
and two studies reported significant loss to follow up (Kiani 1991, Mallory 1991). For these
two studies there were respectively 46 and 52%, and 43 and 38% loss to follow up for the two
intervention groups. These two studies were therefore regarded as being at high risk of bias.
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This, coupled with the fact that surgical site infections were present in only 6 and 9% of the
patients in the two groups in the Kiani study and 3 and 2.5% in the Mallory study, led the
GDG to decide to exclude these studies from the analysis.

No study reported an a-priori power calculation. Two studies (Korpan 1995 and Kraus 1998)
stated that there were no imbalances in the baseline characteristics, and three did not say if
there were baseline imbalances (Kiani 1991, Liu 1995, Mallory 1991). The other study, Al-
Waili 1999 reported differences between groups in the concomitant antibiotics: the antiseptic
group were also given amoxicillin. The GDG therefore decided that this study was likely to be
confounded and it was not considered further.

The risk of bias was assessed for each included study and three studies were assessed as
being at high risk of bias (Al-Waili 1999, Kiani 1991 and Mallory 1991), and were not analysed
further.

Results

Antibiotic 1 versus antibiotic 2

iv imipenem-cilastatin followed by oral ciprofloxacin versus iv levofloxacin followed by
oral levofloxacin
The Liu study compared two antibiotics regimens: iv imipenem-cilastatin 500 mg every six
hours followed by oral ciprofloxacin 750 mg every 12 hours versus iv levofloxacin 500 mg
every 12 hours followed by same dose of oral levofloxacin. Patients had suspected infected
wounds or ulcers, or major abscesses, or significant underlying disease such as diabetes and
peripheral vascular disease. Of the 15/31 patients with a suspected wound infection, 11
(38%) were later confirmed bacteriologically, but it is unclear how these patients were
distributed between groups. Patients were randomised before bacteriological confirmation of
infection.

Primary outcome rate of healing

There was little difference between levofloxacin and imipenem-cilastatin/ciprofloxacin for rate
of healing for all infections, RR 1.09 (95% CI: 0.85 to 1.40). Most patients were healed in both
groups, with all the remaining patients rated as improved. There were no treatment failures
reported. Results were not presented separately for patients with a wound infection.

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1 Figure 1: imipenem-cilastatin/ciprofloxacin versus levofloxacin rate of healing
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Only 38% of the patients had bacteriologically confirmed SSIs, so these results can only be
considered a possible extrapolation, and were used to inform GDG consensus discussions.

Secondary outcomes

Adverse events
Trial authors reported that probable or possible adverse events were uncommon, with only
one case of diarrhoea in the levofloxacin arm, and two cases of diarrhoea, two of nausea and
one of local intravenous site pain in the imipenem-cilastatin arm. It was unclear whether the
cases were patients or events, therefore we were unable to estimate the RR of patients
reporting at least one adverse event.

Cost-effectiveness evidence
Results from the cost-minimisation analysis found that a treatment course of i.v. imipenem-
cilastatin followed by oral ciprofloxacin cost 146.30 per patient compared to 173.92 for a
treatment course of i.v. levofloxacin followed by oral levofloxacin.

Topical mupirocin calcium versus oral cephalexin
One study compared a topical and an oral antibiotic regimen. In this comparison, both the
route of administration and the antibiotic changed at the same time, so that conclusions
cannot be drawn about the relative effectiveness of either the two antibiotics or the route of
administration. Topical mupirocin calcium cream (2% mupiricin) to cover the entire wound
was applied three times daily for 10 days versus oral cephalexin 250 mg four times daily for
10 days (Kraus 1998). Patients weighing no more than 40 kg received cephalexin
suspension four times daily adjusted for body weight (25 mg per kg body weight per day).
Patients had infected wounds such as a small laceration, abrasion or sutured wound that
could be treated with either intervention. In the population of evaluable (n=478) patients, the
types of wounds were: small laceration (32%), sutured wound infection (19%), abrasion
(32%), others (such as infected scratches, pierced body parts and biopsy sites) (17%).
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Primary outcome rate of healing
Rate of healing was determined seven to twelve days after the end of treatment and defined
as: persistent clinical success - complete resolution or sustained improvement of signs and
symptoms of infection with no exudates or pus present in wound, and no additional antibiotics
required; or clinical recurrence: reappearance or worsening of signs and symptoms of infection
that required additional antibiotic therapy; or no valid assessment possible. There was no
significant difference in the number of patients reporting rate of healing at follow-up, RR 1.00
(0.94 to 1.07).

Only 19% of the patients had SSIs, so these results can only be considered a possible
extrapolation, and were used to inform GDG consensus discussions.

Figure 2: topical mupirocin versus oral levofloxacin rate of healing (at follow-up in
ITT population)
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Secondary outcomes

Patient rated outcomes
Of patients completing an end of treatment survey, 484 (72%) preferred topical therapy and
181 (27%) preferred oral therapy, 664 (99%) answered that the cream was easy to apply.

Adverse events
The number of patients reporting an adverse event related or possibly related to the study
drug was reported. There was no significant difference in the number of patients reporting an
adverse event, RR 0.80 (95% CI: 0.49 to 1.30).


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1 Figure 3: number of patients reporting at least one adverse event in ITT population
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The most frequently reported adverse events in both treatment groups were headache,
diarrhoea and nausea reported by 2.0%, 1.1% and 1.1%, respectively of patients in the
mupirocin group and by 1.1%, 2.3% and 1.1%, respectively by patients in the cephalexin
group. None were reported as severe in intensity. For withdrawals due to treatment, the
confidence interval was very wide, OR 1.41 (95% CI: 0.53 to 3.74), so conclusions could not
be drawn.

Figure 4: Mupirocin versus levofloxacin withdrawal due to adverse events all
infections
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Cost-effectiveness evidence
Results from the cost-minimisation analysis found that a treatment course of topical mupirocin
calcium cost 65.70 per patient compared to 3.46 for a treatment course of oral cephalexin.

Solution 1 versus solution 2

Topical honey versus antiseptics
As mentioned above, the one study that compared 12 hourly topical applications of honey
with 12 hourly applications of antiseptic, which included 70% ethanol and povidone iodine
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was considered to be confounded by additional antibiotics in the antiseptic arm. Therefore
analysis is not reported here.

Antibiotics use generally
In the absence of good quality evidence, but in the light of the previous discussion, the GDGs
consensus was that the use of any antibiotic for the management of SSIs should be based on
information derived from a clinical assessment process, which includes bacteriological
screening if possible and referral to an evidence based local antibiotic formulary, produced as
the result of multi-disciplinary work between clinician, pharmacist and microbiologist.

Technique 1 versus technique 2

One study (Korpan 1995) evaluated local continuous microwave (CM) treatment compared
with a placebo treatment with an identical but defective device to maintain blinding. The GDG
excluded this study from the analysis because the treatment is not used in the UK.

Evidence statements and recommendations

Level of
Evidence
Evidence statements


1-




HE



1-




HE



Antibiotic 1 versus antibiotic 2
There is weak evidence from data extrapolated from patients with any infection to
show little difference in cure rate between iv impenem-cilastin then oral
ciprofloxacin compared with iv levofloxacin then oral levofloxacin. Rates for SSIs
(38% of infections) were not reported separately

The treatment course of i.v. imipenem-cilastatin followed by oral ciprofloxacin costs
146.30 per patient compared with 173.92 for a treatment course of i.v.
levofloxacin followed by oral levofloxacin.

There is weak evidence from data extrapolated from patients with any infections to
show no difference in cure rate between topical mupirocin calcium and oral
cephalexin. Rates of healing for SSIs (19% of infections) were not reported
separately

The treatment course of topical mupirocin calcium costs 65.70 per patient
compared with 3.46 for a treatment course of oral cephalexin.


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4 The use of any antibiotic for the management of SSIs should be based on
information derived from a clinical assessment process, which includes
bacteriological screening if possible and referral to an evidence based local
antibiotic formulary, produced as the result of multi-disciplinary work between
clinician, pharmacist and microbiologist.
1
2



Grade

Recommendation
D Any use of an antibiotic for the management of SSIs should be based on
information derived from a clinical assessment process. This includes
bacteriological screening (if possible) and referral to an evidence-based local
antibiotic formulary, produced as the result of multidisciplinary work between
clinician, pharmacist and microbiologist.
3
4
5
6
7





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6.25 Patients information needs, experiences, and quality of
life issues
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Objective
To review the evidence on the information needs of patients undergoing surgery about the
prevention of surgical site infection and experiences of patients with surgical site infections
and the impact on their quality of life.

Criteria for considering studies for this review
Types of studies
Both quantitative (RCTs, case-control, cross-sectional) and qualitative study designs
(interviews) were considered for this review.

Characteristics of clinical studies included in the review (Appendix D25)
Eleven studies were suitable for quality assessment. Of these there were eight studies
included in the review. Reasons for exclusion are provided in Appendix F25.

Four studies were conducted in the UK (Fitzpatrick 1998; Bradshaw 1999; Franks & Moffatt
1999; Neil 2000; Hack 2003) two were in the US (Whitehouse 2002; Perencevich 2003), and
one in Sweden (Persson 1995)

The studies involved adult patients of a varying age range. There were no studies identified
which included neonates, children or carers.

The participants were drawn from a variety of settings ranging from university hospital
settings (Persson 1995; Whitehouse 2002); day surgery (Fitzgerald 1998; Bradshaw 1999);
outpatient wound healing clinics or inpatient hospital units (Neil 2000) and community
hospitals (Whitehouse 2002; Perencevich 2003).

Three studies were on quality of life issues (Franks and Moffatt 1999; Whitehouse 2002;
Perencevich 2003), two studies were on information needs (Fitzpatrick 1998; Bradshaw
1999), one study was on patients attitudes (Persson 1995 ), one review on management of
wounds (Hack 2003) and one on patients' experience of living with wounds (Neil 2000)

Methodological quality of included clinical studies (Appendix E25)
The types of studies identified ranged in study designs including: a randomised study
(Persson 1995), two case-control (Whitehouse 2002; Perecevich 2003), two cross-sectional
(Fitzpatrick 1998; Bradshaw 1999), phenomenological approach (Neil 2000) and two reviews
(Hack 2003; Franks and Moffatt 1999).
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In Persson (1995) the method of randomisation was inadequate, the study was unclear on
allocation concealment, baseline comparability and blinding was not stated. Wounds were
assessed for signs of infection or fluid secretion. Patients were followed up until day of
discharge, however, information on length of stay was not provided.

In the two case-control studies (Whitehouse 2002; Perenvich 2003) indicated comparability
between the cases and the controls matched on age, type of surgical procedure. Whitehouse
(2002) also matched on date of surgery, surgeon and the National Nosocomial Infections
Surveillance (NNIS) risk index. Another criteria cases and controls were matched in
Perenvich (2003) was in the duration of surgical procedure.

Both studies defined surgical site infection in accordance with the NNIS criteria. The follow-up
period varied in the two studies. Perencenvich (2003) followed up at 8 weeks and reported
that 35% did not respond to the questionnaires. Whitehouse (2002) had a lengthy follow up
period of 12 months which may be a suitable time period for following-up on orthopaedic
infections reported a non response rate of 38%. Reasons for drop-outs included mortality
(7%).

The two cross-sectional studies (Fitzpatrick 1998; Bradshaw 1999) used a purposive
sampling and piloted the questionnaires. Fitzpatrick (1998) follow-up period was 7 days
following discharge and Bradshaw (1999) recruited patients 3 months after the surgery.

One study employing a phenomenological approach (Neil 2004) used a purposive sampling
and had respondent validation.

Results
Information needs
Two studies were identified relating to information needs of day surgery patients.
A telephone survey conducted by Fitzpatrick (1998) on patients experiences of varicose vein
and arthroscopy day surgery examined the type of information patients received regarding the
surgical procedure, postoperative pain and wound management. The study found that a
majority (93%) were provided with information on point of contact if wound complications
occurred; 70% were advised on how to care for wounds; and 63% were given information on
duration of wound healing. 90% of the sample had received adequate information about
recovery from surgery but more information regarding the duration of the recovery period was
needed. The sample cited information leaflets (77%); staff nurses (73%) and doctors (23%)
as the key sources of information.

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A study by Bradshaw (1999) examined the information needs of general day surgery patients.
The study found that post-operative leaflets were fraught with jargon, difficult to read or
imprecise. Interviews with patients who had undergone procedures such as appendectomy,
mastectomy or inguinal hernia repair revealed that key areas of concerns and need for
information related to: managing pain, wound infections and bathing.

Patient views and experiences
A study by Persson (1995) randomised patients to have the wounds dressed or exposed and
examined patients attitudes to wound care following abdominal operations. A 7 item
questionnaire examined patients attitudes to: thoughts about their wound, appearance of
wound, worries about infection, worries about wound rupture, showering, staff expertise and
perception of pain. Responses were assessed on a visual analogue scale

The findings indicated that no significant difference was found between the two groups in
terms of their satisfaction with the wound management strategy. There were two areas rated
by patients to be of higher concern were: thoughts about the wound and their perception of
postoperative pain. However, there was no significant difference between the two groups. The
study also found that 65% of the dressed wounds group and 87% of the exposed group
would prefer the same type of management strategy for subsequent operations.

Studies specific to experiences of wounds resulting from surgical incision were limited. A
survey by Fitzpatrick (1998) examined the impact of post-operative pain and wound
complications following surgery. Majority of the patients (97%) experienced post-operative
pain and 23% experienced wound problems such as bleeding or oozing. However, as the
assessment of wound healing was 7 days following discharge, this may not have been
adequate time to assess any complications.

The psychological and social effects of malodorous wounds have been examined in Hack
(2003). The review highlights the need to consider patients feelings of embarrassment,
rejection or withdrawal due to malodorous wounds. The review also stresses that
management and treatment strategies are most effective when care plans are negotiated with
patients and when patients are allowed to make informed choices.

The effect a malodorous wound is not limited to patients but the impact on carers must also
be considered. This view is reflected in a study that used a phenomenological approach to
elicit views of living with a chronic wound (Neil, 2000). The study indicates that health
professionals should involve family members and identifying gaps in knowledge on wound
healing and/or treatment so families are in a better position to assist the patients.

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Neil (2000) also considers the psycho-social aspects of chronic wound management in
patients who were suffering diabetic foot ulcer or pressure ulcers. The themes identified from
the interviews reveal that participants with chronic wounds had to contend with the oozing
and smelling of wound which caused distress and embarrassment, sleep deprivation, and
pain. The pain was due to both the physical discomforts caused by the wound as well as
acute pain caused by treatment such as wound debridement. Participants also revealed that
a sense of being isolated prevented from resuming work or other daily activities.

Quality of life
Studies relating to quality of life issues have been a useful indicator of the psychological and
physical impact of a disease. Generic health-related quality of life instruments such as the
Medical Outcome Study Short-Form 36(SF-36), Medical Outcomes Study 12-item Short-Form
Health Survey (SF-12) or Sickness Impact Profile (SIP) are used to assess QoL outcomes.
The literature review identified only two studies that have examined the impact of SSIs on
QoL. A study by Whitehouse (2003) employed a case-control design to assess the impact of
QoL following an orthopaedic surgery in a cohort with patients with SSI versus controls. SF-
36 scores on the following domains were examined: physical functioning; role-physical; bodily
pain; general health perceptions; vitality; social functioning; role-emotional and mental health.
Significant differences between the two groups were found for the physical functioning
(p=.014) and role-physical domain (p=.022), where the control group scored higher denoting a
better health-related QoL.

A study by Perencevich (2003) used a case-control design to assess the impact of health
related-quality of life in patients who developed SSI versus controls who also underwent
surgery. The SF-12 questionnaire, which entails both a mental health and physical health
component, was used to assess QoL eight weeks after surgery. The results indicate that
there is a significant difference in the post-operative mental and physical components
between the two groups (p=.025 and p=.003 respectively).

In order to assess any changes in the mental and physical health components following the
surgery, the study collected both pre-operative and post-operative SF-12 scores eight weeks
after the surgery. However, the pre-operative which was aiming to assess mental and
physical health status at four weeks prior to the surgery was collected retrospectively at the
eight week point. The results indicate that there was a significant drop in the mental health
component scores for the case-patients (p=.004)

In addition to the SF-12 scale, the questionnaire also considered the implication on activities
and perceived care needs. A significant difference was found between cases and controls in
relation to missing planned activities (p=.004) but no significant differences were found in
terms of missing work or unable to do regular activities. The findings on perceived care
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needs indicated that cases were more likely to require home provider visits (p=.01) but no
significant difference was found for requiring a telephone hotline service.

The evidence, based on the two studies indicates that there is a negative impact on QoL due
to SSI infections.

One study reviewed the generalisability of quality of life instruments. There is criticism
surrounding the use of generic tools such as SF-36 to measure QoL as it may not detect the
subtle differences between cases and control patient groups and may underestimate the
impact of a condition. It is suggested that a combination of the disease-specific and the
generic tool may provide a better assessment of the impact of the condition on a patients
quality of life. The impact of wounds on QoL has been documented using a 'disease-specific'
tool has mainly been in the area of pressure ulcers and leg ulcers but quality of life
instruments specific to assessing the impact of surgical wounds are lacking. (Franks and
Moffat, 1999)

The review has identified studies highlighting the negative impact on quality of life due to
surgical site infection. However, studies examining patients experiences, information needs
and wound management strategies specific to surgical site infections were lacking.

Evidence statements and recommendations

Level of
Evidence
Evidence Statements
2+ A surgical site infection can have significant negative effects on both the
physical and mental wellbeing of patients.
4 The effects of an SSI can range from minor to major and can be short, long-
term or permanent.
1- A poor quality study showed that, of patients randomised to either having
wounds dressed or exposed, there was no difference in the incidence of wound
infections. There was also evidence to indicate that two areas of concern were
how much patients thought about the wound and their perception of
postoperative pain. However, there was no significant difference between the
two groups.

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3 There is a psycho-social impact on patients living with chronic wounds such as
pain, distress and embarrassment caused by malodorous wounds, and feelings
of isolation.

3 The evidence stresses the importance of health care professionals to consider
the psycho-social impact of living with wounds.

2- There is weak evidence to indicate that patients require information on the self-
management of wounds including: healing, post-operative pain and recovery
from surgery.
2- There is weak evidence to suggest that health care professionals should also
aim to provide patients undergoing surgery with information on duration of
wound healing and recovery from surgery.
4 GDG consensus is that patients and carers require information on follow-up
care, assistance with daily living, and longer term consequences of having a
surgical site infection.

1
2



Grade

Recommendations
D Patients undergoing surgery (and their carers) should be fully involved in their
care plan and provided with information on: how to reduce their risk of SSIs;
wound management strategies; signs of postoperative infection.

D Health professionals should be aware of the potential implication of an SSI on
the physical and mental wellbeing of patients and their carers.

GPP Patients who develop an SSI should be fully involved in their care plan. Patients
experiencing long-term effects from an SSI should also be given advice and
support (eg DHSS benefits, transport, OT aids) to ameliorate those effects.

GPP Patients should be fully informed regarding the potential warning signs of
infection (local and systemic). Local signs are an increase in redness, heat,
pain, swelling, smell and wound discharge. Systemic signs include fever.

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7 RECOMMENDATIONS FOR RESEARCH 1
2
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33
34

The following research gaps were identified by the GDG (following NICE
requirements, the first 5 are those that were prioritized by the GDG using a group
consensus process in which every research recommendation was ranked by each
group member -latter process may only be necessary if the GDG generates too
many):
What generic types of modern interactive wound dressing are most effective in
reducing surgical site infection?
'Multi-centred RCT's comparing different generic types of modern interactive wound
management products, following a range of surgical procedures, for SSI prevention in
wounds healing by primary prevention, or the management of infected wounds
healing by secondary intention. Clinical and cost effectiveness outcomes focussing
on rate of SSI, rate of healing, patient acceptability, effectiveness in managing the
symptoms of SSI (e.g. exudate, malodour, local tenderness) and the effects on a
patients health related quality of life will all need to be measured'.
Why this is important
There is currently a paucity of wound dressing evidence that compares generic types.
Clinical trials have typically compared a modern interactive dressing, such as a
hydrocolloid with gauze, demonstrating that the use of gauze should no longer
routinely feature in contemporary practice. What clinicians are not certain of is the
clinical and cost effectiveness of one type of modern interactive dressing when
compared with another. This has created an uncertainty amongst tissue viability
experts when making informed decisions of dressing type used for wounds healing by
both primary and secondary intention. This study would add to current knowledge.
Which antibiotics should be used in the treatment of surgical site infection?
Randomised trials to be undertaken in a range of surgical procedures, in order to
demonstrate the clinical and cost effectiveness of a range of antibiotics used for the
management of surgical site wound infections'.
Why this is important
There is currently some uncertainty regarding choice of antibiotic when treating
surgical site infection. Most treatment is blind in that clinicians choose a broad
spectrum antibiotic to treat infection in the surgical wound, whilst waiting for
microbiology results after taking a wound swab for culture. There is very little research
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1
2
3
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6
7
8
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10
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15
evidence in this area, and this research would enable clinicians to make informed
choices when assessing and then treating an infected wound. This study would add
to current knowledge.
What is the incidence and prevalence of surgical site infection in hospital and
primary/community care settings in England and Wales?
To obtain a more comprehensive picture of the full extent of surgical site infections, a
prospective study should be established for determining both the incidence and
prevalence of SSIs in hospital and primary and community care settings in England
and Wales.
Why this is important
Currently data in this area are collected only through voluntary involvement from NHS
Trusts across England. Date are formally collected by the Surgical Site Infection
Surveillance Service (SSISS), and are useful in determining rough estimates relating
to both the economic and care burden that SSIs place on the NHS. This proposed
study would add to current knowledge.
16
17
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8 Prevention & Management of Surgical Site Infection (SSI) Algorithm 1
2
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Securing the patient environment
Use disposable, sterile single-use drapes +/- incise drapes
Single application of skin antiseptic
(Topical Iodine should not be used on neonates and infants)
Use alcohol based solutions sparingly for safety reasons
Intra operative patient warming and oxygen (80%) administration
(unless contraindicated)
Use warm (37C) sterile saline for body cavity irrigation (if indicated)
(Dilute povidone iodine/saline solution indicated in adult orthopaedic surgery)
Securing the surgical team environment
Change into scrubs (consider re-usable)
Remove nail polish, nail extensions and jewellery
Surgical scrubbing performed at start of operative list involvement
(surgeon, surgical assistant and scrub theatre practitioner)
Alcohol hand rub between operations/dressing changes
Use sterile theatre wear (including double gloving and face masks)
according to risk assessment
Consider disposable gowns and drapes
Preparing the patient
Give patient information on reducing SSI risk
On the day of surgery, patient showers whole body with cleansing agent
If clinically indicated, body hair removed using clippers (single use heads)
Do not give bowel prep for colorectal surgery
Perform preoperative warming
Hand decontamination by those coming into contact with the patient
Treating SSI
Antibiotics following clinical assessment and evidence
based local formulary
Wounds healing by secondary intention? Use a modern
interactive dressing eg. Polyurethane and NOT gauze
Patients experiencing long term SSI effects are given
advice and support (e.g. DHSS benefits, transport, OT aids)
Managing the surgical wound
Patient can choose to shower 24 hours post operatively
Consider sterile dressing technique
Patient awareness re the warning signs of infection
(local and systemic)






Securing the surgical wound
Re-disinfection is not indicated
Close abdominal wall with absorbable suture
Close skin with staples or non-absorbable monofilament suture using an
interrupted percutaneous technique
(Consider alternatives such as absorbable subcuticular sutures eg.children)
Cover (if required) surgical wound with low adherent modern dressing

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9 AUDIT CRITERIA 1
2
3
4
5
6

The audit criteria below are to assist with implementation of the guideline
recommendations. The criteria presented here are considered to be the key criteria
associated with the guideline recommendations. They are suitable for use in primary
and secondary care, for all patients______________________________________.
7
8
9
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24
Caveats for guideline user

9.1 Objectives for an audit
9.2 Individuals to be included in an audit
9.3 Data sources and documentation of audit
Systems for recording the necessary information (which will provide data sources for
audit) should be agreed by Trusts.
Whatever method is used for documentation, the _____________ should be
accessible to all members of the multidisciplinary team.
Documentation of the factors taken into consideration when deciding the most
appropriate intervention should occur.
The fact that carers and patients have been informed about ____________ should be
documented. Patients and carers should be directly questioned about their
satisfaction with, and the adequacy of, the information provided and this should be
documented in either the patient notes or in another source as agreed by the Trust.
Trusts should establish a system of recording when staff have been educated in
_____________________ and should implement a process for reviewing education
needs relating to _______________________.
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1 Table __: Measures that could be used as a basis for an audit
Criterion Standard Exception Definition
of terms
EXAMPLE
Allocation of pressure-
relieving devices (includes
mattresses and overlays,
both high-tech and low-
tech)
Recommendations
1,2,3,4,8

Pressure-relieving devices
are offered to all
individuals vulnerable to or
at elevated risk of
developing pressure ulcers
as determined by holistic
assessment (the results of
which are documented in
the patient's healthcare
notes), within an agreed
time-scale.

Individuals cared for on
pressure-relieving devices
are moved to an
alternative device if their
condition changes, within
an agreed time-scale.
100%











100%
The device is appropriate
for the individual (for
example, a high-tech
device which may be
unstable for patients with
fractures).

The patient declines a
particular device.

The device has been
reported by the patient, or
their carer or is known to
the health professional to
be harmful or
unacceptable to that
patient.
The holistic assessment
as described in
recommendation 1 will
assist with identification of
patients deemed as
vulnerable to or at
elevated risk of developing
pressure ulcers.








2
3
4
5
Calculation of compliance
Compliance (%) with each measure described in the table above is calculated as follows.

Number of patients whose care is consistent with the criterion plus
number of patients who meet any exception listed

100
Number of patients to whom the measure applies

6
7
8
9

Clinicians should review the findings of measurement, identify whether practice can be
improved, agree on a plan to achieve any desired improvement and repeat the measurement
of actual practice to confirm that the desired improvement is being achieved.
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10 DISSEMINATION OF GUIDELINES 1
2
3
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8
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The Guideline will be produced in a full and summary format and a version for
the public (Information for the Public)
Full copies of the Guideline will be available through the NICE website
(http://www.nice.org.uk) in PDF format and summary through the National
Electronic Library for Health NeLH (http://www.nelh.nhs.uk/) and National
Guideline Clearinghouse (http://www.guidelines.gov).

11 VALIDATION

The guideline will be validated through a stakeholder consultation process. The first
draft was submitted to NICE in March 2006. NICE will obtain and collate
stakeholders comments for consideration by the GDG.


12 SCHEDULED REVIEW OF GUIDELINE

The process of reviewing the evidence is expected to begin 4 years after the date of
issue of this guideline. Reviewing may begin earlier than 4 years if significant
evidence that affects the guideline recommendations is identified sooner. The
updated guideline will be available within 2 years of the start of the review process.
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