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Prospective, nonrandomized controlled

trials to compare the effect of a silk-Like

Fabric to standard Hospital Linens on the

r ate of Hospital-acquired Pressure ulcers

Joseph Coladonato, MD; Annette Smith, RN, MSN; Nancy Watson, BSN, RN, CMSRN;

Anne T. Brown, RN, MSN, PCCN; Laurie L. McNichol, RN, MSN, GNP, CWOCN; Amy

Clegg, MSN, RN, CWOCN; Tracy Griffin, BSB; Lora McPhail, RN, BSN; and Terry G.

Montgomery, PhD

abstract

Hospital bedding and gowns influence skin moisture, temperature, friction, and shear, which in turn may affect the de -

velopment of pressure ulcers. To evaluate the effect of a new silk-like synthetic fabric on the incidence of pressure ulcers

in an acute care setting, two consecutive 6-month clinical trials were conducted among 307 consecutively admitted

patients in a Medical Renal Unit (August 2008 and March 2010) and in 275 patients admitted to a Surgical Intensive Care

Unit (ICU) (September 2009 to March 2010). During the first 8 weeks, all patients used standard hospital bed linens, re -

usable underpads, and gowns. During the second 8 weeks, all admitted patients used the intervention linens (a silk-like

fabric) followed by another 8 weeks of control (standard linen) use. Demographic variables and the prevalence of pres-

sure ulcers on admission were statistically similar for control and intervention groups in both study populations with the

exception of gender in the Renal Unit study (13% higher proportion of men in intervention group). Average Braden Scores

were also similar and low (<18) in all study patients. Upon admission to the Medical Renal Unit, 21 of 154 patients (13.6%

) in the control and 26 of 153 patients (17.0%) in the intervention group had a pressure ulcer. The incidence of new ulcers

was 12.3% in the control and 4.6% in the intervention group (P = 0.01); average length of stay was 5.97 days = 4.0) for

control and 5.31 days (σ = 3.8) for intervention patients (P = 0.07). In the Surgical ICU group, 18 of 199 patients in the con -

trol (9.1%) and four of 76 patients in the intervention group (5.3%) were admitted with a pressure ulcer; the incidence of

new pressure ulcers was 7.5 % in the control and 0% in the intervention group (P = 0.01). Average length of stay was 4.5

days and 4.33 days in the control and intervention groups, respectively (P = 0.33). The significant differences between

the control and intervention group in the rate of pressure ulcer development suggests that the type of linens used affect

pressure ulcer risk and that this silk-like synthetic fabric technology may help reduce the incidence of pressure ulcers in

high-risk patients. Controlled clinical studies in other patient populations are warranted.

Keywords: clinical study, bedding and linens, pressure ulcer, prevention, incidence

Index: Ostomy Wound Management 2012;58(10):14–31

Potential

conflicts

of Interest: Ms. McPhail and Dr. Montgomery disclose they are employees of Precision Fabrics

Group, Inc, Greensboro, NC, the manufacturer of the study fabric.

Dr. Coladonato is Medical Director, Medical Renal Unit, Moses H. Cone Memorial Hospital, Greensboro, NC. Ms. Smith is Vice President of Nursing, Wesley Long Community Hospital, Greensboro, NC. Ms. Watson is Assistant Director of Nursing Renal/Medical-Surgical; and Ms. Brown is Department Director- Surgical ICU-2300, Moses H. Cone Memorial Hospital. Ms. McNichol is a Clinical Nurse Specialist/WOC Nurse, Wesley Long Community Hospital. Ms. Clegg

is a Nurse Practitioner, Moses H. Cone Memorial Hospital. Ms. Griffin is Director of Supply Chain Operations, Cone Health System. Ms. McPhail is a Nurse

Consultant and Dr. Montgomery is a Vice President, Precision Fabrics Group, Inc, Greensboro, NC. Please address correspondence to: Terry G. Montgomery, PhD, Precision Fabrics Group, Inc, 301 North Elm Street, Suite 600, Greensboro, NC 27401; email: terry.montgomery@precisionfabrics.com.

  • 14 ostomy wound management ® october 2012

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w hether patients are cared for at home, in hospitals, or in nursing homes, their support surfaces are typically

covered by bed linens manufactured of fabrics comprised

of either polyester/cotton or 100% cotton fibers.

  • 1 Patient

gowns are made of similar fabrics. these cotton-blend fab -

rics have no special properties or performance attributes,

such as moisture management or antimicrobial properties,

despite the special needs of healthcare environments.

  • 2 In

most healthcare facilities, bed linens and patient gowns are

managed as housekeeping items.

  • 3 although a patient’s skin

remains in constant contact with bedding and gown fabrics

during the hospital stay, these cotton linens and gowns are

not intended to be part of the therapeutic process.

the ability of a product to wick away moisture rapidly,

transport moisture vapor, and dry quickly are important fac-

tors in helping fragile skin stay dry and minimize macera-

tion. 4-6 reviews of the literature 7-10

have determined that ex-

posure of tissue to moisture from perspiration, incontinence,

or wound exudate immediately increases these friction and

shear forces; prolonged exposure to moisture also increases

the adverse effects of friction and shear forces on tissue by

further weakening the intercellular bonds in the epidermal

layers, causing maceration and epidermal ulceration.

textiles and pressure ulcer formation. a limited number

of studies have specifically addressed both the effect of textile

materials on skin moisture, temperature, friction, and shear

for patients in healthcare settings and the possibility that tex-

tile materials could play a role in formation and prevention

of pressure ulcers. biesecker et al

  • 4 evaluated commercially

available healthcare bed linens and reusable underpads to

ostomy wound management 2012;58(10):14–31

Key Points

L aboratory studies have shown that fabrics com -

monly used in patient care environments may affect

skin moisture, shear, and friction, but clinical study

data are very limited.

T he authors conducted controlled clinical studies in

two patient care units.

D uring the study, all admitted patients either used

regular hospital linens (during a period of 8 weeks) or

linens composed of a silk-like synthetic fabric (for a

duration of 8 weeks).

In both patient care units, the incidence of hospital-

acquired pressure ulcers (including Stage I) was lower

in the intervention than in the standard linen group.

T he results of this study are encouraging and warrant

additional controlled clinical studies in other high-risk

patient populations.

discussed. t h e authors’ findings highlighted the difficulty

in relying on in vitro experiments to realistically represent the

skin/fabric biomechanical system; the authors concluded the

role textiles play in the formation and prevention of pressure

ulcers is generally understudied, despite its potential influ-

ence on factors that contribute to skin ulceration, specifically

pressure, shear/friction, and skin hydration.

Friction and fabrics. Friction is the adherent force that

determine which biomechanical properties reduce the devel-

opment of pressure ulcers. specifically, two types of bedding

(100% cotton and 50% cotton/50% polyester) and eight un-

derpads of differing constructions were mechanically tested

using an inclined plane and compared to assess their coef-

resists shearing of the skin, which may result in epidermal

or dermal abrasion as the patient moves or is repositioned in

bed. Friction and shear can occur when a patient moves or

is moved across the coarse surface of a cotton bed sheet.

4,11

gerhardt

  • 11 conducted in vivo measurements to demonstrate

ficient of friction (coF) when wet and dry. the coFs of wet

cotton bedding and wet polyester/cotton bedding were found

how epidermal hydration affects friction between the skin

and textile fabrics: 22 caucasian par ticipants (average age

to be almost two times greater than dry bedding.

31.7 years, average body mass index [bmI] 23.3) rubbed

another biomechanical study by Pryczynska et al

5

  • evalu- their inner forearm against a hospital fabric and a plate

ated the effects of different bed linen fabric weave patterns

measuring force. Highly linear relationships between skin

on frictional and moisture-management properties and how

moisture and skin-fabric friction were found for each par-

they could affect the moisture, friction, and shear forces sur-

rounding bedbound patients. the shor tcomings of tradi-

tional bedding with regard to the prevention of skin dam-

age, such as abrasions and chafes and pressure ulcers, were

discussed. three cotton-fiber blend levels were evaluated in

four weave patterns. the study verified the value of synthetic

fibers, blended with cotton, in providing a smooth linen sur-

ticipant. gerhardt also found that coFs of skin against wet

cotton-polyester fabric exceeded those of skin against dry

cotton-polyester fabric by a factor of more than two. In a ret-

rospective, correlation study

12,13

of 347 patients (average age

69 years, 73.5% caucasian, 13.8% black/african american,

admitted to a medical-surgical Icu), data were collected on

65 pressure-related wounds, 20 stage I, and 45 stage II, stage

face, as well as an embossed fabric construction to facilitate

III, and stage IV ulcers. development of stage II, stage III,

moisture drainage.

In a survey of the literature, Zhong et al 6 reviewed bio -

mechanical research related to the interactions between textile materials and human skin; specifically, the skin responses to moisture, heat transfer, and friction were

and stage IV pressure ulcers was found to be almost six times

more likely for patients with high exposure to friction and shear than in patients with low exposure. new fabric technology. recognizing deficiencies in the ability of cotton-blend healthcare fabrics to keep patients’

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october 2012 ostomy wound management ®

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Figure 1. Photomicrograph comparison of silk-like fabric (left) and cotton-blend fabric (right). skin dry and to

Figure 1. Photomicrograph comparison of silk-like fabric (left) and cotton-blend fabric (right).

skin dry and to minimize friction and shear,

  • 14 a new silk-like

fabric technology manufactured by Precision Fabrics group,

Inc (greensboro, nc) was developed for use as bed linen or bed

sheets to provide a generally cleaner, drier, smoother surface than

that exhibited by cotton-blend fabrics, thus minimizing friction

between the skin and fabric. as seen in Figure 1, continuous-

filament yarns woven into the silk-like synthetic fabric provide a

smooth support surface, free of broken or discontinuous fibers.

this enhanced smoothness helps minimize the potential for ir-

ritation and abrasion of sensitive skin. the silk-like fabric is a

plain-weave construction of 100% continuous-filament yarns,

where 100% nylon yarns are woven in one direction of the fab-

ric, and >99% polyester yarns in the other (perpendicular) di-

rection. the polyester yarns have a nonround fiber cross-section

to create microchannels to facilitate moisture wicking and rapid

drying more quickly than is possible with cotton (see Figures

2 and 3).

  • 15 this new fabric technology also incorporates a du-

rable antimicrobial treatment to overcome cotton’s inherent

greensboro, nc from august 2008 to march 2010. the initial

trial was conducted in the medical renal unit from august 2008

to January 2009. once the medical renal unit trial was com-

pleted and the results were analyzed and reviewed, a decision

was made to repeat the trial in a separate unit within the hospital

with a different patient population similarly at risk for pressure

ulcers. the second trial took place in the surgical Intensive care

unit (Icu) from september 2009 to march 2010. the fabric

evaluated in the studies (dermatherapy®) was developed and

manufactured by Precision Fabrics group, Inc, greensboro, nc.

to derive an appropriate sample size for the two studies,

available research involving the prevention of pressure ul-

cers was reviewed.

  • 18 In almost all cases, the number of par-

ticipants was <100. a sample size of two times the highest

sample size of the published studies — ie, approximately 200

subjects — was deemed appropriate.

Investigational review board (Irb) approvals for the

studies were obtained from the 17-member moses cone

tendency to facilitate the growth of bacteria.

  • 16 to control growth

of odor- and stain-producing bacteria and fungi, a commer-

cially available antimicrobial agent — a quaternary ammonium

Health system Irb.

methodology. the study protocols for both trials in-

volved three sequential sessions. during the first 8 weeks of

compound (3-trimethoxy silyl propyl dimethyl octadecyl am-

each trial, all patients admitted to the study units who met

monium chloride) — is applied to the fabric.

  • 17 the inclusion criteria used the control items. during the sec-

the purpose of this study was to evaluate the effect of bed

linens, underpads, and patient gowns made with the silk-like

ond 8-week period, all patients admitted to the study units

who met the inclusion criteria used the intervention items.

fabrics (hereafter referred to as the “Intervention”) in reduc-

during the third 8-week period, all patients admitted to the

ing the development of pressure-induced wounds.

methods and Procedures

two prospective, nonrandomized controlled trials were conducted in succession at moses H. cone memorial Hospital,

study units who met the inclusion criteria used the control

items. Patients whose stay in the units overlapped the control and intervention sessions were excluded from the study data — ie, patients included in the study data were either on the control or intervention items for their entire stay in the units.

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Figure 2. Moisture wicking rates of healthcare bedding fabrics. 15 Figure 3. Drying rates of healthcare
Figure 2. Moisture wicking rates of healthcare bedding fabrics. 15
Figure 2. Moisture wicking rates of healthcare bedding
fabrics. 15

Figure 3. Drying rates of healthcare bedding fabrics.

15

Products. c on trol items included a conventional,

usual-care hospital flat top sheet, fitted bottom sheet,

pillowcase, underpad, and patient gown, all made with

cotton-blend fabrics. Intervention items included a flat

top sheet, fitted bottom sheet, pillowcase, underpad, and

patient gown, all made with the silk-like fabric. t he in -

tervention underpad was identical to the control under -

pad with the exception of the top surface fabric; the layer

closest to the patient’s skin was comprised of the silk-

like fabric. t he inner “soaker” layer and moisture barrier

used in the intervention underpad were the same as used

in the control underpad.

Populations. the patient populations in the medical re -

nal unit and the surgical Icu were chosen because patients

had multiple comorbidities and had been identified as being

at high-risk for pressure ulcer development.

Inclusion/exclusion criteria.

the inclusion criteria for

both trials included male or female patients of any race, ad-

mitted to the units for a minimum of two consecutive days (48 hours). Patients who were placed on specialty beds (eg, pressure-reduction beds, bariatric beds) upon admission or during their hospital stay were excluded.

s tudy protocol. a convenience sampling method was used and all patients admitted or transferred to the r enal

u nit who met the inclusion criteria were asked to consent

to be part of the trial. as a result of the experiences and

results from the r enal u nit study, no informed consent

was obtained from patients in the subsequent s urgical

I cu study. this devia tion from the study protocol was ap -

proved by the I rb.

care protocol. all enrolled patients received treatment

normally provided for their medical needs for the duration

of the study. standard care treatment included the appro-

priate use of pressure-reduction positioning, ongoing man-

agement for nutritional stability, moist wound dressings for

participants admitted with a pressure ulcer, and appropriate

incontinence management for all study patients.

one deviation from standard care protocols occurred in

the surgical Icu study. during the control study period,

standard Icu departmental patient-care protocols were

used; patients with early signs of a pressure ulcer were placed

directly on mattress overlays, without the use of fitted sheets.

Patients who did not exhibit early signs of a pressure ulcer re -

mained on standard-care cotton fitted sheets. during the in-

tervention session, the intervention fitted sheets were placed

over the mattress overlays when overlays were used. no other

modifications were made in the Icu standard-care protocols.

this deviation in the Icu study protocol also was approved

by the Investigational review board.

data collection. the following variables were collected at

admission and extracted from the records of all patients who

participated in the two studies:

• Patient demographic data — weight, gender, age, and the

medical diagnosis of each patient;

• Patient history and comorbidities, including but not

limited to hypertension, anemia, diabetes, and kidney

disease;

Albumin level, a basic screening tool for monitoring pro -

tein levels and used as a part of the standard care protocol

at cone Health system. albumin levels are an indicator

of nutritional status and fluid balance. albumin measure -

ments below normal levels of 3.6 g/dL have been found to

indicate a potential risk for pressure ulcer formation

19,20

;

• Braden scores, a widely used and validated assessment

tool available to assess patients’ risk of developing pres-

sure wounds.

  • 21 In addition to admission assessment, the

braden scale score was obtained on a daily basis, consis-

tent with hospital protocol. For the purpose of this study,

only admission braden scale scores were used. each pa-

tient’s primary nurse recorded daily skin assessments per

hospital protocols.

In both studies, the primary endpoint was the develop -

ment of new pressure ulcers. For patients with a pressure ulcer, computerized case report forms were used to record and monitor wound information including wound loca- tion, stage, size, wound bed color, drainage, and condition of

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table 1. m edical renal unit study: patient variables

 
 

Control

Intervention

 

groups

group

(n=154)

(n=153)

 

Variable

Mean

SD

Mean

SD

P

Weight (Kg)

80.0

25.0

78.9

20.2

.32

Age (years)

63.2

14.0

62.5

16.5

.23

Albumin level (g/dL)

2.84

0.6

2.80

0.8

.32

scale. 21 Patients were otherwise provided the usual standard of care. only data from wounds identified as stage I through

stage IV pressure ulcers, unstageable ulcers, and deep tissue

injury (dtI) wounds were collected. other wounds, such as

postoperative surgical site infections or soft-tissue infections,

were not included.

data storage. two files were used to de-identify patient

criteria and protect patient confidentiality: one included the

patients’ medical record numbers and was linked to the sub -

jects’ study Id numbers. this file, linking patients’ medical

record numbers and their study Id numbers, was maintained

in a secure location within the cone Health system, accessi-

ble only to those individuals who were authorized to view it.

table 2. m edical renal unit study: patient comorbidities

 
 

Control groups

Intervention group

 

(n=154)

(n=153)

Comorbidity

n(%)

SD

n (%)

SD

P

Hypertension

117 (76.0%)

0.4

108 (70.6%)

0.5

.14

Anemia

101 (65.6%)

0.5

78 (51.0%)

0.5

.005

Diabetes

82 (53.2%)

0.5

75 (49.0%)

0.5

.23

Renal failure

80 (52.0%)

0.5

68 (44.4%)

0.5

.10

Kidney disease

53 (34.4%)

0.5

50 (32.7%)

0.5

.37

Atherosclerosis

50 (32.5%)

0.5

48 (31.4%)

0.5

.31

Pulmonary

44 (28.6%)

0.5

40 (26.1%)

0.5

.32

Heart failure

32 (20.8%)

0.4

23 (15.0%)

0.4

.10

Cerebrovascular

27 (17.5%)

0.4

27 (17.6%)

0.4

.49

accident

Infectious disease

20 (13.0%)

0.3

27 (17.6%)

0.4

.13

Neoplasm

20 (14.3%)

0.4

25 (16.3%)

0.4

.31

Drugs/alcohol

14 (9.1%)

0.3

25 (16.3%)

0.4

.03

Thrombophlebitis

12 (7.8%)

0.3

14 (9.2%)

0.3

.34

Myocardardial

10 (6.5%)

0.3

15 (9.8%)

0.3

.15

infarction

Dementia

8 (5.2%)

0.2

17 (11.1%)

0.3

.03

a second separate file, which included the data

collection tool, was only linked to the subjects’

study Id numbers.

data analysis. descriptive statistics were

used to summarize all demographic, comor-

bidity, and outcome variables. Intervention

and control group averages were compared

using the t-test, assuming equal variance; for

comparisons, P <0.05 was considered statisti-

cally significant.

statistical calculations were performed us-

ing statPlus® Professional software (v2009),

analystsoft, Inc, alexandria, Va.

results

medical renal unit study. a total of 307

patients were enrolled in the study on the

medical renal unit. of those, 154 were in the

control and 153 in the intervention group; in

the control group 59 were men and 95 were

women, compared to 78 men and 75 women

in the intervention group (P = 0.02).

on ad-

mission, with the exception of gender, no sig-

nificant differences in demographic variables

(weight, age, and albumin level) were observed.

the average weight of the control and the in-

tervention patients was 80.0 Kg (σ = 25.0) and

78.9 Kg (σ = 20.2), respectively (P = 0.32). av-

erage ages of the control and the intervention

patients were 63.2 years (σ = 14.0) and 62.5

years (σ = 16.5), respectively (P = 0.23). the

proportion of men in the intervention session

was 13% higher than in the control group (P =

0.02), and albumin levels for control and inter-

vention patients averaged 2.84 g/dL (σ = 0.6)

and 2.80 g/dL (σ = 0.8), respectively (P = 0.32)

(see table 1).

surrounding skin. all pressure ulcers were documented and staged per national Pressure ulcer advisor y Panel (nPuaP) guidelines by staff nurses who are educated annually on as- sessment and staging of pressure ulcers and use of the braden

the vast majority of patients had several comorbidities, including hypertension (225, 73.5%), anemia (179, 58.5%), diabetes mellitus (157, 51.3%) and renal failure (148, 48.4%), but few significant differences between patients in the control

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table 3. m edical renal unit study: admission braden s cale scores

 
 

Control

Intervention

 

groups

group

(n=154)

(n=153)

 
 

Mean

SD

Mean

SD

P

Perception

3.19

0.6

3.15

1.8

.28

Moisture

3.50

0.7

3.56

0.5

.19

Activity

2.66

0.9

2.56

1.0

.21

Mobility

2.98

0.6

2.94

0.8

.31

Nutrition

2.49

0.7

2.53

0.7

.31

Friction

2.27

0.6

2.33

0.6

.18

Total Braden Score

17.08

2.7

17.07

3.1

.49

 

table 4. m edical r enal u nit study: number of

 

pressure ulcers per patient

 
 

Control

Intervention

 

groups

group

(n=154)

(n=153)

 
 

Mean

SD

Mean

SD

P

Pressure ulcers at

  • 0.188 0.229

0.5

0.6

.25

admission

All pressure ulcers

  • 0.136 0.052

0.4

0.3

.01

developed during

stay

Stage I pressure

  • 0.110 0.039

0.4

0.2

.02

ulcers developed

during stay

Stage II+ pressure

  • 0.065 0.020

0.3

0.1

.02

ulcers developed

during stay

Pressure ulcers at

  • 0.279 0.177

0.6

0.5

.05

discharge

and intervention groups were observed (see table 2). ane -

mia was more common in the control group, whereas drugs/

alcohol and dementia were more common in the interven-

tion group. the average total braden score for all patients on admission was 17.1, but differences in braden subscale and total score between control and intervention patients were small (see table 3). Patients with braden scores of 15 to 18

are considered at risk for developing pressure ulcers. 21 braden scores for patients in the renal study averaged 17.1 in both

the control (σ = 2.7) and intervention groups (σ = 3.1) (P =

0.49) (see table 3). the collective data analysis of patients at

admittance indicates a good homogeneous mix in the renal

unit study.

on admission, the percentages of patients with pressure

ulcers in the control and intervention groups were 13.6% (σ

= 0.3) and 17.7% (σ = 0.4), respectively (P = 0.21) (see tables

4 and 5). during the study, 19 of 154 patients (12.3%, σ =

0.3) in the control and seven out of 153 patients in the in-

tervention group (4.6%, σ = 0.2) developed a pressure ulcer

(P = 0.01) during an average length of stay of 5.97 days (σ

= 4.0) for control and 5.31 days (σ = 3.8) for intervention

patients (P = 0.07). at discharge from the renal unit, 20.1%

(σ = 0.4) of control patients still had a pressure ulcer, com-

pared to 13.7% (σ = 0.3) of intervention patients (P = 0.07).

the average number of days between admission and pres-

sure ulcer development was 6.8 (n = 21 wounds; σ = 3.7) for

control versus 7.8 (n = 8 wounds; σ = 6.7) for intervention

patients. the average number of pressure ulcers per patient

in the control group increased from 0.188 to 0.279 (48%) be -

tween admission (σ = 0.5) and discharge (σ = 0.6) (P = 0.08),

while the average number of pressure ulcers per patient in

the intervention group decreased from 0.229 to 0.177 (23%)

between admission (σ = 0.6) and discharge (σ = 0.5) (P =

0.19) (see table 4).

the average number of new pressure ulcers per patient

was 0.136 (σ = 0.4) in the control and 0.052 (σ = 0.3) in

the intervention group (P = 0.01). of those, 0.11 new stage I

pressure ulcers per patient developed in the control group (σ

= 0.4) for a total of 17 pressure ulcers, while 0.04 new stage

I pressure ulcers per patient for a total of six pressure ulcers

developed in the intervention group (σ = 0.2) (P = 0.02).

Further, 10 pressure ulcers or 0.07 new stage II and higher

pressure ulcers per patient developed in the control group

(σ = 0.3), and three pressure ulcers or 0.02 new stage II and

higher pressure ulcers per patient developed in the interven-

tion group (σ = 0.1) (P = 0.02). Patients using the interven-

tion linens had 36.8% fewer pressure ulcers at discharge from

the renal unit than patients in the control group (P = 0.05),

or 0.117 versus 0.279 wounds per patient, respectively. In the

control group, 31 patients were discharged with 43 pressure

ulcers (61.4 %) compared to 21 patients in the intervention

group, who were discharged with 27 pressure ulcers (38.6

%). during the first 8-week control period, the average num-

ber of pressure ulcers per patient was 0.12 (σ = 0.4). during

the 8-week intervention period, the number of pressure ul-

cers per patient averaged 0.05 (σ = 0.2). during the second

8-week control period, the number of pressure ulcers per pa-

tient averaged 0.16 (σ = 0.4). surgical Icu study. a total of 275 patients were enrolled in the surgical Icu study. of those, 117 were men and 82 were women in the control group and 44 were men and 32 were

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table 5. m edical r enal u nit: number of patients with pressure ulcers (P us)

 
 

Control group 1

Control group 2

Control groups

Intervention

 
 

N=98

N=56

1+2

group

 

N=154

N=153

 

n (%)

SD

n (%)

SD

n (%)

SD

n (%)

SD

P

C1

P

C2

P

C1+2

Patients with PUs: all stages

 

At admission

16 (16.3%)

0.4

5 (8.9%)

0.3

21 (13.6%)

0.3

26 (17.0%)

0.4

.45

.07

.21

Developed PUs

10 (10.2%)

0.3

9 (16.1%)

0.4

19 (12.3%)

0.3

7 (4.6%)

0.2

.04

.003

.01

during stay

At discharge

21 (21.4%)

0.4

10 (17.9%)

0.4

31 (20.1%)

0.4

21 (13.7%)

0.3

.06

.23

.07

Patients with Stage I PUs

 

At admission

3 (3.1%)

0.2

1 (1.8%)

0.1

4 (2.6%)

0.2

14 (9.2%)

0.3

.03

.10

.20

Developed PUs

9

(9.2%)

0.3

6 (10.7%)

0.3

15 (9.7%)

0.3

5 (3.3%)

0.2

.02

.02

.01

during stay

At discharge

11 (11.2%)

0.3

5 (8.9%)

0.3

16 (10.4%)

0.3

12 (7.8%)

0.3

.18

.40

.22

Patients with Stage II+ PUs

 

At admission

13 (13.3%)

0.3

5 (8.9%)

0.3

18 (11.7%)

0.3

14 (9.2%)

0.3

.15

.48

.23

Developed PUs

4

(4.1%)

0.2

6 (10.7%)

0.3

10 (6.5%)

0.2

3 (2.0%)

0.1

.16

.003

.02

during stay

At discharge

14 (14.3%)

0.4

9 (16.1%)

0.4

23 (14.9%)

0.4

11 (7.2%)

0.3

.03

.03

.02

 
 

the most common comorbidities were hypertension

table 6. surgical Icu study: patient variables

 

(150, 54.5%), atherosclerosis (111, 40.4%), diabetes (92,

 

33.5%), and pulmonary problems (88, 32.0%). only the pro -

 

Control

Intervention

 

portion of patients with pulmonary problems and anemia

groups

group

were significantly higher in the control than in the interven-

tion group (see table 7). the average total braden scores were

(n=199)

(n=76)

 

Mean

SD

Mean

SD

P

16.2 (σ = 2.8) in the control and 16.5 (σ = 2.8) in the inter-

 

vention group (P = 0.08) (see table 8). the average number

 

Weight (Kg)

89.6

25.6

88.7

22.1

.40

of pressure ulcers per patient on admission was 0.131 (σ =

 

0.5) in the control and 0.132 (σ = 0.6) in the intervention

 

Age (years)

64.4

14.9

65.6

12.6

.28

group (P = 0.50) (see table 9).

 
 

by the end of the 24-week trial period, a total of 15 pa-

Albumin level (g/dL)

2.63

0.7

2.67

0.9

.38

tients had developed a pressure ulcer: 7.5% of patients in

women in the intervention group (P = 0.47). average patient

weight was 89.6 Kg (σ = 25.6) in the control group and 88.7

Kg (σ = 22.1) in the intervention group (P = 0.40). average

patient age in the control and intervention groups was 64.4

years (σ = 14.9) and 65.6 years (σ = 12.6), respectively (P = 0.28). albumin levels were low but not significantly different between patient groups (average 2.63 g/dL (σ = 0.7) and 2.67 g/dL (σ = 0.9) (P = 0.38) (see table 6).

the control groups developed nine stage I and 12 stage II or

greater ulcers and 0% of patients in the intervention group

developed pressure ulcers during an average length of stay

of 4.58 days (σ = 4.0) for control and 4.33 days (σ = 4.9) for

intervention patients (P = 0.33). the average number of days

between admission and pressure ulcer development was 3.4 days (range = 5 days; n = 21 wounds; σ = 1.6) for control versus 0 days (range = 0 days; n = 0 wounds; σ = 0) for inter- vention patients.

  • 24 ostomy wound management ® october 2012

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table 7. surgical Icu study: patient comorbidities

 
 

Control groups

Intervention group

 

(n=199)

(n=76)

 

n(%)

SD

n (%)

SD

P

Hypertension

112 (56.5%)

0.5

38 (50.0%)

0.5

.17

Atherosclerosis

82 (41.0%)

0.5

30 (39.0%)

0.5

.41

Pulmonary

74 (37.0%)

0.5

14 (18.4%)

0.4

.002

Diabetes

72 (36.0%)

0.5

20 (26.3%)

0.4

.06

Neoplasm

46 (23.0%)

0.4

12 (15.8%)

0.4

.10

Heart failure

38 (19.0%)

0.4

15 (19.7%)

0.4

.45

Renal failure

34 (17.0%)

0.4

11 (14.5%)

0.4

.31

Myocardardial

24 (12.0%)

0.3

6 (7.9%)

0.3

.17

infarction

Anemia

16 (8.0%)

0.3

2 (2.6%)

0.2

.05

Cerebrovascular

14 (7.0%)

0.3

3 (4.0%)

0.2

.17

accident

Drugs/Alcohol

12 (6.0%)

0.2

5 (6.6%)

0.3

.43

Pressure ulcers

12 (6.0%)

0.2

2 (2.6%)

0.2

.13

Asthma

10 (5.0%)

0.2

3 (4.0%)

0.2

.36

Thrombophlebitis

10 (5.0%)

0.2

2 (2.6%)

0.2

.20

the average number of pressure ulcers per patient in the control group increased from

0.131 to 0.186 (42%) between admission (σ =

0.5) and discharge (σ = 0.6) (P = 0.16), while

the average number of pressure ulcers per pa-

tient in the intervention group decreased from

0.132 to 0.105 (20%) between admission (σ

= 0.6) and discharge (σ = 0.3) (P = 0.39) (see

table 9).

on admission, the percentages of patients

with pressure ulcers in the control and inter-

vention groups were 9.1% (σ = 0.3) and 5.3%

(σ = 0.2), respectively (P = 0.15) (see table 10).

during the study, 15 of 199 patients (7.5%, σ

= 0.3) in the control and 0 of 76 patients in

the intervention group (0%, σ = 0) developed

a pressure ulcer (P = 0.01). at discharge from

the surgical Icu, 11.6% (σ = 0.3) of control

patients still had a pressure ulcer compared to

5.3% (σ = 0.2) of intervention patients (P =

0.06).

discussion

In acute care hospitals, the incidence of

pressure ulcers ranges from 3% to 29.5%, with

the higher rates found in critical care areas of

the hospital.

  • 21 In a national prevalence/inci-

dence study

23,24

of data obtained between 1999

and 2004 in the united states, the overall num-

ber of patients who developed pressure ulcers

after admission in acute care settings remained

steady at 7.6%. In the current study, with the

exception of 0% incidence for the intervention

group in the surgical Icu study, the overall in-

the average number of new pressure ulcers per patient

cidence of patients with pressure ulcers ranged from 4.6% to

was 0.106 (σ = 0.4) in the control and 0.0 (σ = 0) in the inter-

vention group (P = 0.02). of those, 0.05 new stage I pressure

ulcers per patient developed in the control, while 0.0 new

stage I pressure ulcers developed in the intervention group.

(P = 0.09). Further, 0.06 new stage II and higher pressure

ulcers per patient developed in the control group and 0.0 new

stage II and higher pressure ulcers developed in the interven-

tion group. (P = 0.02). Patients using intervention had 43.4%

fewer pressure ulcers at discharge from the surgical Icu than

patients in the control group (P = 0.16), or 0.186 versus 0.105

wounds per patient, respectively. In the control group, 23 pa-

tients were discharged with 37 pressure ulcers (82%) com-

pared to four patients in the intervention group who were

discharged with eight pressure ulcers (18%). during the first

8-week control period, the average number of pressure ulcers

per patient was 0.13 (σ = 0.4). during the 8-week interven-

tion period, the number of pressure ulcers per patient aver- aged 0.0 (σ = 0). during the second 8-week control period, pressure ulcers per patient averaged 0.08 (σ = 0.4).

20.1% — within the ranges found in the literature. Further,

the facility-acquired incidence for control patients in the

current study in the renal and surgical Intensive care units

was 12.3% and 7.5%, respectively. although the incidence of

12.3% found in the renal unit study is higher than predicted

for a general acute care population, it is important to note

the renal and surgical Icus selec ted for the current stud-

ies were more likely to reflect higher-than-normal incidence

rates, but the direct relationship between patients with renal

failure as a comorbidity and the incidence of pressure ulcers

has not been well investigated. relevant data can be found in

a 2003 survey

  • 25 by the Victorian Quality council ( VQc ) of

48 health ser vices in metropolitan, rural, and regional areas,

representing slightly more than 7,000 beds, conducted to bet-

ter understand the incidence of pressure ulcers for a range

of cohorts. In the VQc survey, patients with pressure ul- cers with renal failure as a comorbidity were found to have an incidence rate of 42%. similarly, patients in Icus are typically bedbound, unconscious, with respiratory failure,

  • 26 ostomy wound management ® october 2012

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table 8. surgical Icu study: admission braden s cale scores

 

Control

Interven -

groups

tion group

(n=199)

(n=76)

 

Mean

SD

Mean

SD

P

Perception

3.20

0.8

3.22

0.7

.33

Moisture

3.47

0.6

3.51

0.6

.15

Activity

2.04

1.0

2.04

1.0

.49

Mobility

2.69

0.6

2.76

0.6

.08

Nutrition

2.50

0.6

2.64

0.7

.004

Friction

2.28

0.6

2.36

0.6

.05

Total Braden Scores

16.2

2.8

16.5

2.8

.08

 

table 9. s urgical I cu study: number of pressure

ulcers per patient

 

Control

Intervention

groups

group

(n=199)

(n=76)

 

Mean

SD

Mean

SD

P

Pressure ulcers at

  • 0.131 .50

0.5

0.132

0.6

admittance

All pressure ulcers

  • 0.106 .02

0.4

0.000

0.0

developed during

stay

Stage I pressure

  • 0.045 .09

0.3

0.000

0.0

ulcers developed

during stay

Stage II+ pressure

  • 0.060 .02

0.3

0.000

0.0

ulcers developed

during stay

Pressure ulcers at

  • 0.186 .16

0.6

0.105

0.3

discharge

or immobilized for substantial time periods while undergo-

ing life support measures, which increases the risk of pres-

sure ulcers.

  • 25 a nested case-controlled study by baumgarten

et al 26 that evaluated extrinsic risk factors such as admission to an Icu determined the odds of having pressure ulcers were twice as high for persons with an Icu stay as for those without an Icu stay. thus, the incidence rates for pressure

ulcer development for control patients in the current study fall within the range associated with patients in renal units

and Icus as reported in the literature. However, it should be

noted that the 4.6% and 0% incidence rates in the renal unit

and surgical Icu associated with pressure ulcer development

for the intervention groups in the current study were gener-

ally below the levels reported elsewhere.

Limitations

Patients were not told into which groups they had been

placed, but due to the differences in product texture, the in-

tervention items were easily distinguished from the control.

members of the nursing staff also were able to identify the

intervention products, although their standards of care re -

mained consistent throughout the study.

due to the need to maintain segregation of control and

intervention items and the logistical requirements associated

with laundering, both trials were carried out in three sequen-

tial stages: 8 weeks on control items, followed by 8 weeks on

intervention items, and then 8 weeks on control items. as

previously stated, patients involved in the transitions from

control to intervention products and intervention to control

products were excluded from the analyzed data. only pa-

tients using either the control or intervention items for their

entire stay in the study units were included in the study data.

this arrangement did not allow for simultaneous random-

ization of patients on the control and intervention products.

the effect of existing pressure ulcers as a risk factor for

developing additional pressure ulcers was not examined, but

baseline prevalence did not differ between the two groups.

the studies were conducted in only two hospital units.

therefore, the results were limited to two patient popula-

tions: renal and surgical Icu patients.

multiple steps were taken in this sequential study design to

minimize bias: 1) baseline risks of pressure ulcers for patients

in the Intervention and control groups were measured on

a daily basis throughout both studies to ensure consistency;

2) demographic data, including weight, age, albumin levels,

comorbidities, gender, and braden scores at admittance for

the before and after control and intervention groups showed

no clinically significant differences affecting bias; 3) before

and after control groups were included to reduce bias; 4) all

groups were studied for 8 weeks with no overlap between

control and intervention group subjects with regard to prod-

uct use; 5) study nurses were blinded with respect to study

data and trends in wound care; 6) mattresses were identical

for all patients; 6) studies were sufficiently sized to detect

clinically important differences in endpoints; 7) all wound

stages, including stage I wounds, were included in the study

sample and the analysis; study data were analyzed with and

without stage I pressure ulcers to assess the degree of con- sistency in observations; and 8) patient participants were examined daily by the nursing staff to determine the pres- ence and stage of wounds. the nursing staff used nPuaP

  • 28 ostomy wound management ® october 2012

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table 10. s urgical I cu study: number of patients with pressure ulcers (P us)

 
 

Control group 1

Control group 2

Control groups

Intervention

 
 

N=101

N=98

1+2

group

 

N=199

N=76

 

n (%)

SD

n (%)

SD

n (%)

SD

n (%)

SD

P

C1

P

C2

P

C1+2

Patients with PUs: all stages

 

At admission

12 (11.9%)

0.3

6 (6.1%)

0.2

18 (9.1%)

0.3

4 (5.3%)

0.2

.07

.41

.15

Developed PUs

10 (9.9%)

0.3

5 (5.1%)

0.2

15 (7.5%)

0.3

0 (0%)

0.0

.002

.02

.01

during stay

At discharge

14 (13.9%)

0.3

9 (9.2%)

0.3

23 (11.6%)

0.3

4 (5.3%)

0.2

.03

.17

.06

Patients with Stage I PUs

 

At admission

1 (1.0%)

0.1

1 (1.0%)

0.1

2 (1.0%)

0.1

1 (1.3%)

0.1

.42

.43

.41

Developed PUs

3

(3.0%)

0.2

3 (3.1%)

0.2

6 (3.0%)

0.2

0 (0%)

0.0

.07

.06

.06

during stay

At discharge

3 (3.0%)

0.2

4 (4.1%)

0.2

7 (3.5%)

0.2

1 (1.3%)

0.1

.23

.14

.17

Patients with Stage II+ PUs

 

At admission

11 (10.9%)

0.3

5 (5.1%)

0.2

16 (8.0%)

0.3

3 (4.0%)

0.2

.05

.36

.12

Developed PUs

9

(8.9%)

0.3

2 (2.0%)

0.1

11 (5.5%)

0.2

0 (0.0%)

0.0

.004

.11

.02

during stay

At discharge

13 (12.9%)

0.3

6 (6.1%)

0.2

19 (9.6%)

0.3

3 (4.0%)

0.2

.02

.26

.06

guidelines for staging wounds, but because multiple nurses

were involved in making wound assessments, bias could have

occurred in interpretations of guidelines and the potential

transient nature of stage I pressure ulcers must be taken into

consideration. However, any wounds in question during the

study were adjudicated by an independent nursing observer.

conclusions

In two separate studies involving a total of 582 patients,

the therapeutic performance of silk-like synthetic bedding

and patient gown products was compared with conven-

tional cotton-blend products currently used in hospitals and

healthcare facilities. In both patient care settings, the inci-

dence of pressure ulcers was lower in patients using the in-

tervention than those using standard hospital linens. In the

medical renal unit, the incidence of facility-acquired pres-

sure ulcers was 12.3% in the standard compared to 4.6% in

the intervention linen group. similarly, in the surgical Icu,

the incidence of pressure ulcers was lower in the intervention (0 %) than in the control group (7.5%). these findings indi- cate that state-of-the-art synthetic textile materials have the potential to reduce the development of pressure ulcers and,

  • 30 ostomy wound management ® october 2012

thereby, contribute to better healthcare outcomes for patients

at risk for or who have pressure ulcers. additional studies in

other populations such as long-term care are warranted. n

references

  • 1. 2005 North American Edition Comparative Operating Revenues and Ex- pense Profile for the Healthcare Textile Maintenance Industry. Published by Phillips & Associates, Inc, 2006. Available at: www.trsa.org. Accessed September 14, 2012.

    • 2 Internal testing of healthcare cotton-blend fabrics by Precision Fabrics Group, Inc, January – June, 2011.

      • 3. Private communication from Terry Montgomery, Precision Fabrics Group Inc, June 6, 2012, after meeting with management representatives of fif- teen leading US healthcare institutions.

      • 4. Biesecker JE, Thomas HL, Thacker JG, Blackwood HS, Edlich RF. Innova- tions in the design and performance of underpads for patients with burns. J Burn Care Rehab. 1995;16(1):66–73.

      • 5. Pryczynska E, Lipp-Symonowicz B, Wieczorek A, Gaszynski W, Krekora K, Bittner-Czapinska E. Sheet fabrics with biophysical properties as elements of joint prevention in connection with first- and second-generation pneumatic anti-bedsore mattresses. Fibers Textiles Eastern Eur. 2003;4(43):50–53.

      • 6. Zhong W, Xing MM, Pan N, Maibach HI. Textiles and human skin, mi- croclimate, cutaneous reactions: an overview. Cutan Ocul Toxicol. 2006;25(1):23–39.

      • 7. Reger S. How does pressure, shear, friction and microclimate lead to ul- ceration. Presentation to the National Pressure Ulcer Advisory Panel, 11th Annual Conference, Arlington, VA. February 27–28, 2009.

        • 8 Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, et al. Moisture-associated skin damage: overview and pathophysiology. J WOCN. 2011;38(3):233–241.

www.o-wm.com

  • 9. Black JM, Gray M, Bliss DZ, Kennedy-Evans KL, Logan S, Baharestani M, et al. MASD Part 2: Incontinence-associated dermatitis and intertriginous dermatitis: a consensus. J WOCN. 2011;38(4):359–370.

    • 10. Ayello EA, Baranoski S, Lyder C, Cuddigan J. Pressure ulcers. In: Baranos- ki S, Ayello EA, eds. Wound Care Essentials: Practice Principles. Philadel- phia, PA: Lippincott Williams & Wilkins. 2004;240-70.

    • 11. Gerhardt LC, Strassle, Lenz A, Spencer ND, Derler S. Influence of epi- dermal hydration on the friction of human skin against textiles. J R Soc Interface. 2008;5(28):1317–1328.

    • 12. National Pressure Advisory Panel 2011. Available at: www.npuap.org/pr2. htm. Accessed October 10, 2011.

    • 13. Cox J. Predictors of pressure ulcers in adult critical care patients. Am J Crit Care. 2011;20(5):364–375.

    • 14. Kurtz EJ, Ylverton CB, Camacho FT, Fleischer AB Jr. Use of a silk-like bedding fabric in patients with atopic dermatitis. Pediatr Dermatol. 2008;25(4):439–443.

    • 15. Data from internal testing at Precision Fabrics Group, Inc. 2011.

    • 16. Pyrek KM. Medical Fabrics: A Reservoir of Pathogenic Bacterium? Infec- tion Control Today. December 31, 2008. Available at: www.infectioncon- troltoday.com. Accessed April 8, 2009.

    • 17. Quaternary ammonium antimicrobial agent is marketed as Aegis

®

; manu-

factured by Microban. Available at: www.microban.com/. Accessed Janu-

  • 19. Terekeci H, Kucukardali Y, Top C, Onem Y, Celik S, Oktenli C. Risk as- sessment study of the pressure ulcers in intensive care unit patients. Eur J Intern Med. 2009;20(4):394–397.

  • 20. Beddhu S, Kaysen GA, Yan G, Sarnak M, Agodoa L, Ornt D, et al. As- sociation of serum albumin and atherosclerosis in chronic hemodialysis patients. Am J Kidney Dis. 2002;40(4):721–727.

  • 21. Bergstrom N, Braden BJ, Laguzza A, Holman V. The Braden Scale for Pre- dicting Pressure Sore Risk. Nurs Res. 1987;36(4):205–210.

  • 22. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Prac- tice Guideline Number 3. Agency for Health Care Policy and Research (DHHS/PHS), Rockville, MD. 1992. Available at: www.eric.ed.gov/PDFS/ ED357247.pdf. Accessed February 15, 2012.

  • 23. Whittington KT, Briones R. National Prevalence and Incidence Study: 6-year sequential acute care data. Adv Skin Wound Care. 2004;17(9):490–494.

  • 24. Reger S, Ranganathan VK, Sahgal V. Support surface interface pressure, microenvironment, and prevalence of pressure ulcers: an analysis of the literature. Ostomy Wound Manage. 2007;53(10):50–58.

  • 25. Pressure

Ulcer Prevalence Survey (PUPPS) Report 2003; State Govern-

ment of Victoria, Australia, Department of Health. Available at: www.

health.vic.gov.au/qualitycouncil/downloads/pupps2/-statepupps_report.

pdf. Accessed February 15, 2012.

  • 26. Baumgarten M, Margolis DJ, Localio AR, Kagan SH, Lowe RA, Kinosian B,

ary 6, 2012.

et al. Extrinsic risk factors for pressure ulcers early in the hospital stay: a

  • 18. McInnes E, Jammali-Blasi A, Bell-Syer SEM, Dumville JC, Cullum N. Sup-

nested case-controlled study. J Gerontol A Biol Sci Med. 2008; 63(4):408-

port surfaces for pressure ulcer prevention. Cochrane Database System

413.

Rev. 2011;4:CD0017835.

www.o-wm.com

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