Student ID:2020383 Wound Management Strategy or Treatment

MOD001947 TRI F01CAM

A CRITICAL ANALYSIS TO
EVALUATE WHTHER TOPICAL
NEGATIVE PRESSURE IS AN
EFFECTIVE WAY TO MANAGE
DIABETIC FOOT ULCER
WOUNDS.

MODULE: MOD001947 TRI F01CAM

STUDENT ID:2020383
WORD COUNT:2530

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Student ID:2020383 MOD001947 TRI F01CAM

INTRODUCTION

Diabetic Foot Ulcers are contemplated as one of the most common and life-
threatening chronic complications of diabetes (Abbott et al. 2002) since they subsidise to high
morbidity, hospitalization (Rice et al. 2014) and mortality rates all of which critically
endanger the excellence of life of diabetic patients. (Brownie et al. 2020). More than 400
million individuals wide-reaching endure from diabetes and about 15% of all these patients
might develop a diabetic foot ulcer (DFU) during their life expectancy. (National Diabetes
Audit Integrated Specialist Survey, 2020). Which is estimated to be 3.6 million people in the
UK with diabetes, which equals to one in every 16 people (Diabetes UK,2016) DFU results
in roughly 50-70% of all lower limb amputations (National Institute for health and Care
Excellence,2019). A holistic approach is required to favourably treat patients with DFUs by
including ultimate diabetes and illness management pressure-alleviating strategies, restoring
pulsatile blood stream and efficient local wound care. (Ndip, Williams, and Edward et
al.2011)

Wound healing is a systemic process that begins with an injury and persists with a
series of physiologic reactions that entails the stages of haemostasis, inflammation, and
repair. Haemostasis with fibrin formation creates a protective wound scab. (Watret et al.,
2019). The scab provides a surface beneath which then follows a cellular morphology of
migration and movement to form the wound bed (Lincolm et al,2016). Inflammation brings
nutrients to the area of the wound, removes debris and bacteria, and provides chemical
stimuli for wound repair (Tsuji et al., 2020). Repair begins instantly after mutilating and
progresses promptly through the processes of epithelialization (Fabian et al), fibroplasia, and
capillary proliferation into the healing area (Brownhill et al., 2020). The process of
angiogenesis, granulation tissue formation and epithelial regeneration is regulated by primary
and secondary intentions of healing contributing to the physiology of wound healing (Meszes
et al., 2017). 

Topical negative pressure wound therapy is a popular therapy that aids in speedy and
safer recovery of patients suffering from DFU as contrary to the tedious conventional wound

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care management (Vig et al. 2011). It is a latest technology with microprocessor controlled
physical wound healing modality known as Negative wound pressure therapy (NPWT)
(“Abstracts of the Tissue Viability Society Annual Meeting, Peterborough” 2008,). In this
therapy a vacuum seal is established by placing dressing inside the wound with vacuum
assisted closure on top of it. (Petrova and Edmonds 2015).Many publications and literatures
supports evidence of the pathophysiology of wound healing(cellular and molecular
morphology) with the mechanism the  NPWT follows i.e. slowly isolating of the wound
hence it aids in removing excessive discharge by creating a moist wound (Argenta and
Morykwas 1997), preventing oedema(Kamolz et al), creating mechanical effects on wound
edges(Wackenfors et al), decreasing bacterial colonization(Mouses et al), increasing
perfusion(Chen et al), stimulating angiogenesis and granulation tissue formation(Fabian et al)
and thereby speeding the recovery process(Yang et al). The device is used in both acute and
chronic wounds and the patients (Borys, Ludwigs, and Sweryn et al ) are placed with it for
around 6 to 8 weeks and is changed approximately thrice in a week this may vary according
to the wound bed preparation, (Schultz et al) mentions that if the TIME acronym is properly
assessed and analysed by the clinician as well as the right patient before opting for this mode
of treatment would contribute to the positive wound environment of the wound bed
preparation.  (Tissue,inflammation/Infection,Moisture,Edge,Regeneration,Social  Factors)
used during the stages of wound assessment to directly correlates with the wound matrix
which is fundamental to TNP in which interstitial fluid flow can modify the intracellular and
extracellular matrix components and organization of the assessed wound bed and increase the
perfusion and granulation. (DeFranzo, Marks, and Argenta 1999). It regulates growth factor
expression, generates granulation tissue (Kremers et al) and utilises the natural viscoelastic
forces of the skin (Kairinos et al) to salvage compromised wound tissue in the wound bed to
the zones of trauma. (Rodrigues et al,2019)

Wound care standards echo and emphasize a mounting consequence of a patient-

involved holistic evaluation (NICE ,2014) when approached with NPWT, the risks and
contraindications should be understood. NPWT has numerous benefits which includes
reduced incidence of infection and fewer secondary amputations (Muller, MRkonijic, and
Kwasny et al..1997). It helps in improving the quality of life as they are easier to manage.
The smaller sized pumps (PICO) are easily portable and produce minimal sound than the
larger ones making it more acceptable to the patient (Clinical trial Facility of California, And
Francisco, Florida, Chicago). This treatment requires lesser frequency of change in the

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Student ID:2020383 MOD001947 TRI F01CAM

dressings thereby saving time and resources. (Sharpe and Myers 2018). Therefore a  therapy
that reduces wound leakage considerably and cuts down the hospital stay post-surgery
(Caroline et al. 2017) in comparison to the conventional dressing, NPWT has a positive effect
on the mental and physical health of the patient. (Afsaneh, Robert, and Kirsner 2018). This
form of the treatment is modern and a lot more non-intrusive as compared to other pre-
existing methods of healing wounds. Thus, this essay will critically analyse a research over
its research design, methodology, discussion and some of the literature and review
NPWT(TNP) role in treating the DFU.

The German DFU- RCT conducted by (Dortheie et al)with her team on NPWT is
important because of its nature as a contemporary form of treatment and many studies
presented that NPWT had positive effects on wound healing with the quantifiable evidence of
insight, case reports and series, small cohort studies and inadequately power-driven or low-
worth randomised trials that have recognized comprehensive use of NPWT in various clinical
settings and established a significant number of periodicals with inclusive diminutive
evidence. Evidence based Practice stresses that leading the growth of clinical practices should
be grounded on the most recent evidence and research (Pierson & Schelke, 2009). For this
reason, the study is important as while proposing this recent RCT the only underpinning of
basis were two randomised controlled trials (RCT’s) presented by (Armstrong and
Lavery,2005) and (Blume et al,2008) provided a solid basis. The title of the research was apt
as it wanted to compare the NPWT with standard moist wound care (SMWC) according to
local norms and benchmarks that has been clearly recorded in the study. The description
given in the review of literature makes the notion of NPWT clear to readers. Accuracy and
lucidity of the research methodology can be found throughout research. The abstract of the
research clearly delineates the structure of the study as a statement of the problem, the
research process, and the overall findings justifying a structure in the analysis. The sole aim
of the DiaFu study was to weigh whether the efficacy and safety of NPWT is enhanced to
SMWC in German real life-clinical practise setting. The complete purpose of the study is
backed by the specific objectives of having primary and secondary outcomes was wound
closure within 16 weeks (Zhang et al,2017). Secondary results were wound-related and
treatment-related adverse events (AEs), amputations, time until ideal wound bed preparation,
wound size and wound tissue structure(Vaidhya et al,2015), pain and quality of life (QoL)
(Moffatt et al,2011) within 16 weeks, and recurrences and wound closure within 6 months

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relatable to the benchmark stated by (Lavery et al,2008) The inclusion criteria and exclusion
criteria ie patients with diabetic foot ulcers both with peripheral neuropathy and peripheral
arterial occlusive disease, which corresponds to the distinctive diverse patient population in
real-life clinical practice evidently portraying generalization in the demographic
characteristics in both the group(Dumvillie JC et al,2018) besides the wounds were debrided
of necrotic tissue before application of assigned therapy(Carvaggi C et al,2009). The vivid
inclusion and exclusion criteria did have a negative impact on the analysis of the study in
relations to the results it stated. The multicentre controlled clinical superiority trial, using
blinded consequence gauged patients that were randomised in a 1:1 ratio stratified by study
site and ulcer severity grade using a web-based-tool with appropriate concealment is missing
in other 3 RCT done by (Armstrong et al 2005, Paola et al 2007, Bume et al,2008).368
patients were randomised, and 345 participants were subdivided among 40 surgical and
internal medicine inpatient and outpatient facilities specialized in diabetic foot care
throughout Germany exhibited a good, initiated process of using a qualification checklist in
selection of the healthcare centres as IIT population, PP population, sub group analysis
comparator treatments and variety of endpoints respectively prohibiting meta-analysis thus
overestimating the data.(Schaper NC,2004). This is one of the qualities of a good problem
statement as Ryan, Coughlan and Cronin (2007) point out. Special training given to the
investigators for both the treatments hence ensuring quality and compliance as best clinical
practise but there is no mention of active monitoring of them as follow up throughout the
study which added to the flaw in the results. Documentation in terms of photographs as well
as blinded valuation was done using WHAT analysis which added to the credibility of the
result but the therapy application was at the choice of the medical investigators (treating
physician as he was not blinded to treatment allocation is a point of potential bias).Meta-
analysis became inapplicable due to the variety of wound types solely mentioned as “small
wounds” and “large wounds” which did not have much scientific citations to define the
treatment(Dowsett et al,2014). This study started in 2011 and ended in 2014 due to its long-
prolonged nature. It was exceedingly difficult to avoid certain factors which subsidised the
false result i.e., many study sites declined to enthusiastically take part in the study due to the
lack of time, staff shortage for documentation. This resulted in recruiting fresh research
nurses overseeing the integrity and balancing the loss which led to a high number of missing
endpoint documentations, untimely termination of NPWT and illicit therapy changes
undesirably affecting the treatment outcome of wound closure leading to restrictions  which
suggestively subsidised the data to be statistically inconclusive.(Mcllwraith T et al,2015) In

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appendage, clinically related outcomes, such as quality of life(Kazem et al,2019), adverse

consequences, and pain(Pediani,2001), were either unheeded or described using a clinically
unsustainable approach of measurement(Guest JF et al),One can, therefore, partially trust in
the reliability and veracity of the evidence provided in the research. Both patients and staff
knew about the allotment to the negative pressure wound therapy or standard wound therapy
which could not be blinded because of the nature of the intervention mentioned by (Moffatt et
al,2011). There was immense pressure over the investigator to produce the findings as the
results had to be provided until the end of 2016 as a basis for the decision of the Federal Joint
Committee to respond to the question if the NPWT can be accepted as a standard service
which would indirectly make the health insurance company to reimburse preventing
economic loss. An upright ethical practise is demonstrated by using informed written consent
from the participants as well as registering the study to the Clinical trias.gov and the German
Trial Registry. The statistical analysis was extracted from previous studies that mainly
focused on the modified intention to treat (IIT) population and no interim analysis was done
mainly the computer program of Dupont and Plummer was used for sample size calculations,
Fisher's exact test comparing the two treatments along with log-rank test was used. The
method of Bonferroni-Holm was used for adjustments for the alfa errors. Qualitative
variables were compared with Chi-square test and visual analogue scale while last
observation carried forward (LOCF) was used in cases of missing values. for group analysis
for all evaluation criteria. Overall study operation and safety was scrutinized by a data
monitoring committee which was a good quality initiation. Interestingly, the study was
originated by a syndicate of 19 constitutional German health insurance funds, which offered
cohesive care conventions for all study participants defining rudimentary rules for study
strategy based on the necessities from the German authorities; and provided a critical
appraisal of the study protocol and producing final report which initiated a security in the
research. The study was sponsored by the firms of KCl and S&N, delivering the NPWT
devices and allied disposable provisions in the allocated zones of Germany with its
manufacturing guidelines and necessary support information about it (Armstrong et al,2005).
Since it did not have any role in the data collection, study design data analysis and,
interpretation or writing the report showing being impartial. But no documentation of the
certification and calibration of the NPWT used. Since the research was planned in a
systematic manner (Ubbink et al,2008,2011) the final execution of the plan had deprived
quality, which was compromised because of extensive sample sizes, so deep analysis in terms

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of related to exclusion and inclusion criteria which led losing the participants and
impossibility of blinding (Sepulveda, et al 2009) in certain areas. Finally, publication bias is a
noteworthy reflection when weighing the evidence regarding the effectiveness of TNP in
relation to the primary and secondary outcomes which did not show substantial difference
between TNP and control group as the hypothesis stated in the study was nullified.

Conclusion

After reviewing the literature revolving around NPWT the German DiaFiu-RCT it not only
improves knowledge but also focuses on understanding its mechanism and how it can be
efficiently tailored for its application on the patients. Thus, the major’s keys points which can
be drawn are the Practical application and care Guidance regarding appropriate patient
selection and the practicalities of applying NPWT is readily available from companies
supplying the system, locally in Trust procedures. (Smith and Nephew, 2009 & 2019).
Involvement of the multidisciplinary team specially the foot care team and specialist for
debridement and foot analysis at any early stage(NICE,2019).Competent in assessing the
wound (TIMER), taking medical history; diagnosis and whether appropriate for NPWT (i.e.
considering the contraindication),skilfully of those applying and changing the medical device
and patient education and timely documentation (Apelqvist et al, 2017).NPWT has
significantly reduced the healing time as well as the death rate because of DFU when
compared to patients under conventional care. NPWT dressings have an array of
comprehensive applications that are beneficial. The one-use handy NPWT have radically
enhanced patient care, supported speedy wound healing, and is cost effective (EWMA,2020)
TNP treatment is not the remedy for all wounds; The Cochrane report (2010) mentions that
there is lack of high excellence in the trials where the there are aspects that shows it is bias
However, it does have a substantial transformation in the wounds as seen in many cases taken
up in the trial. Therefore, more studies are required to generalise its implication and
managing various types of chronic wounds (Wounds International, 2020). Moreover,
pondering the actual condition of medical resources accessible in emerging countries, an
adapted NPWT device may be an impending direction in research trials towards wound
healing with NPWT in resource-poor settings. Thus it can be concluded that the researches
did try to bring out the best from the previous RCTs they reviewed but still couldn't achieve a
significant result due to its many flaws even though they had a strong structured methodology

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but couldn't achieve it on practical grounds and is critically appraised in the essay hence it
can be considered as a valid form evidence-based studies which can be replicated in future.

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