Art & science tissue viability supplement
Reviewing the evidence for advanced dressings Butcher M, White R (2013) Reviewing the evidence for advanced dressings. Nursing Standard. 27, 45, 51-62. Date of submission: March 12 2013; date of acceptance: April 19 2013.
Abstract The principles of moist wound healing have become widely accepted since the seminal work of George Winter in the 1960s. In the subsequent 50 years, many publications have extolled the clinical value of modern or advanced wound dressings. This article reviews the findings of two studies arguing that the benefits of advanced wound care products, which are based largely on the principles of moist wound healing, cannot be justified in terms of healing outcomes or cost effectiveness. These studies have the potential to affect clinical practice and decision making, and the article highlights the importance of analysing and interpreting the findings of such studies cautiously.
Authors Martyn Butcher Independent tissue viability and wound care consultant, South West Wound Care Consultancy, Devon. Richard White Professor of tissue viability, University of Worcester, Worcester. Correspondence to:
[email protected]
Keywords Advanced dressings, evidenced-based practice, research, wound care interventions, wound management
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The inTegraTion of evidence-based medicine in patient care, and particularly in wound management, is a goal to which all involved in tissue viability aspire. Various organisations have developed and disseminated clinical practice guidelines as part of an evidence-based medicine approach to wound care (Queen 2007). These guidelines are based on scientific evaluation of research literature combined with expert opinion and, in some cases, express patient preferences. There is ongoing debate about what type of evidence is appropriate for the accurate assessment of wound care interventions, and whether the randomised control trial (rCT) is the only form of evidence that should be considered (Maylor 2008, White 2008, Bell-Syer et al 2009, Leaper 2009a, 2009b, ashby et al 2010, gottrup et al 2010). however, the fact remains that each year many research based or research-linked manuscripts are published investigating wound care and wound interventions. Despite this, bodies such as the Cochrane Collaboration and the national institute for health and Care excellence (niCe) claim that there is a paucity of reliable evidence to support the use of the majority of wound interventions (fletcher et al 1997, Cullum et al 2001, Jull et al 2002, Vermeulen et al 2004, 2007, Palfreyman et al 2006, Chambers et al 2007, Storm-Versloot et al 2010). What constitutes ‘good’ evidence depends largely on the perspective of the reviewer and the standard he or she establishes. as such, the review process undertaken by the Cochrane Collaboration may be seen as the most stringent, although many commentators feel that this standard is flawed as it fails to recognise the importance of non-rCT research (White 2008, Leaper 2009a, 2009b). The clinician and health service manager should examine research carefully, including the hypothesis being tested, the way this testing is carried out (methodology), results obtained and relevance to clinical care. This is essential before incorporating study findings into practice.
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Art & science tissue viability supplement it is, therefore, surprising that a few studies have come to light recently that raise major questions about how wounds have been managed for the past 40 years through the use of modern or advanced dressings (MereC 2010). Despite being few in number, the influence these studies appear to have exerted on health service managers and those seeking to control health service expenditure is significant. in turn, these studies have the potential to affect clinical practice and decision making. This article assesses the findings and recommendations of two such studies by Jeffcoate et al (2009) and Michaels et al (2009). Some of the flaws in trial design and interpretation of findings are identified, and the influence of these studies on clinical practice and decision making is questioned.
Background it is generally accepted that advances in wound dressings began following the work of george Winter in the 1960s (Winter 1962), although clinical studies by Bull et al (1948) demonstrated the benefits of a moist (occlusive) environment for wound healing almost 20 years previously. Since then, there has been significant progress in understanding the biology and physiological process of acute and chronic wounds in relation to how they heal (Lazarus et al 1994) or fail to respond to treatment (Mast and Shultz 1996, nwomeh et al 1998, 1999, Yager and nwomeh 1999). This knowledge led to the development of dressings that are not simply ‘passive’, in that they provide only an absorbent covering for the wound, but rather manage exudate to: establish and maintain an optimum moist environment (Bishop et al 2003); reduce or avoid pain through atraumatic properties (Klode et al 2011); prevent or treat infection by providing an effective barrier function (Downie et al 2010) and/or antimicrobial components (Leaper et al 2010); and affect healing positively via other influences on the wound bed. further advances have enabled active agents to be incorporated in wound dressings. The most contentious of these, in view of its unit cost to healthcare providers and apparently unremarkable performance in systematic reviews of rCTs, are dressings containing silver (gottrup 2006, Michaels et al 2009, Drug and Therapeutics Bulletin 2010, White 2010). These are broad-spectrum antimicrobials and are indicated for the treatment of critically colonised (Sibbald et al 2005) or locally infected wounds. other examples of advanced
dressings with intrinsic biological effects that will not be considered further in this article include extracellular matrix components, protease modulating matrices, growth factors, skin equivalents and/or substitutes, and tissue-engineered products. Management of chronic or hard-to-heal wounds, such as diabetic foot ulcers, venous leg ulcers and pressure ulcers, is challenging. approximately 200,000 people in the UK at any one time have such a wound (Posnett and franks 2007). These patients are cared for mainly by nurses in the community (Drew et al 2007, Vowden and Vowden 2009). The direct cost to the nhS of caring for patients with such wounds is an estimated £2-3 billion per year (Posnett and franks 2007). in addition, there may be substantial indirect costs, including prescribing and dispensing of treatments such as analgesia, which are unknown or unrealised (Butcher and White 2011). hard-to-heal wounds tend to affect older people and those with multiple health problems. The increased incidence of diseases such as diabetes, cardiovascular disease and microcirculatory disorders associated with the ageing population, are key factors in the escalation in the number of patients presenting with chronic wounds. There were 420 million people worldwide aged 65 years or older in 2007. This number is projected to increase to 974 million in 2030. in addition, the number of patients with diabetes is expected to double from 171 million in 2000 to 366 million in 2030 (Wild et al 2004). These factors are likely to make the management of wounds more challenging.
Moist wound healing and advanced dressings Low technology dry, gauze-based dressings, such as those described as non-adherent, woven and non-woven, and conforming bandages are generally referred to as traditional dressings (Tibballs 2009). These dressings operate in a dry or wet-to-dry wound environment and have long been considered an ineffective or inefficient wound intervention (alvarez 1988, Queen et al 2004, Korting et al 2011). Despite this, approximately half of global wound dressing sales are still accounted for by such products (Tibballs 2009). The main reason for this is that the unit cost of such dressings is invariably less than that of advanced dressings. examples of advanced dressings, which function in a moist wound healing environment, include alginates, hydrocolloids, foams,
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Art & science tissue viability supplement hydrofibre, collagens, hydrogels and transparent films (British national formulary (Bnf) 2012). Since the 1960s, there has been growing consensus among wound care experts that the creation of a moist environment provides the ideal conditions for wound healing (Winter 1963, Winter and Scales 1963, Cherry et al 2000, Jones 2005). The majority of wound and tissue viability experts agree that moist wound healing techniques should be used routinely, so much so that this is now the standard in many textbooks (Lawrence 1996, Jones et al 2006a, Thomas 2010). Many articles have also been published extolling the advantages of moist wound healing, particularly in chronic wounds (falanga and eaglstein 1986, Kannon and garrett 1995, Jones et al 2006b, 2006c, Benbow 2008, olson et al 2009, Snyder and hanft 2009).
Controversy
Moist wound healing has been challenged in systematic reviews (Chaby et al 2007, Ubbink et al 2008) and rCTs (Jeffcoate et al 2009, Michaels et al 2009). There is a suggestion that cheaper traditional dressings should be used when the evidence for more expensive dressings is not definitive in terms of the time to healing (Chaby et al 2007, Michaels et al 2009). one review of clinical data on surgical wounds goes as far as to claim that moist wound dressings have no advantage over gauze-based dressings in terms of minimising pain at dressing change (Ubbink et al 2008), which is somewhat contrary to most evidence (Mudge and oersted 2010). With reference to the preoccupation with time to healing as the only endpoint, the effect of chronic wounds on patients’ quality of life, in terms of heightened sensations of pain and factors such as isolation, reduced self-worth and loss of income, is significant. Bearing this in mind, healing per se is not necessarily the goal of treatment (Stephen-haynes and White 2010). a clinically efficient dressing should, in addition to promoting the overall aim of wound healing, modulate the healing environment by promoting autolytic debridement or reducing bacterial colonisation (bioburden). once these goals have been achieved, another dressing may then be appropriate. for example, some dressings also alleviate odour or excess exudate and offer wound protection (hilton et al 2004). Queen et al (2004) emphasised that a moist environment soothes exposed nerve endings, thus mimimising or avoiding wound-associated pain. it is often too easy to neglect, or even disregard, the views and concordance of the patient. however, it is essential for healthcare providers
to accept that non-clinical influences affect clinical decision making, and that there will always be a gap between guidelines and practice (hajjaj et al 2010). The implications of studies such as those by Jeffcoate et al (2009) and Michaels et al (2009), which conclude that the benefits of advanced dressings cannot be justified in terms of healing outcomes or cost effectiveness, are significant and require closer scrutiny before they become accepted as the basis for changes in clinical practice (Stephen-haynes and White 2010).
Michaels et al (2009) study in 2009, Michaels et al published the findings of a trial comparing the efficacy and cost of a variety of silver dressings with standard low-adherence dressings placed under multilayered compression bandaging in the treatment of venous leg ulcers. The study was initially published in the form of a health technology assessment report commissioned by the nhS. Since publication, this report has become a cause for concern among tissue viability specialists with regard to its findings, namely that ‘there was no evidence to support the routine use of silver-donating dressings beneath compression for venous ulceration’ (Michaels et al 2009). This concern has been raised as the report has been cited as a scientific rationale for removing silver dressings from wound care formularies (White 2010). The study was a pragmatic, prospective, non-blinded randomised trial, which included a cost-effectiveness component. a total of 213 patients were involved in the trial and randomised to receive one of five active silver treatments (n = 107) or a non-silver, non-antimicrobial, low-adherence dressing (n = 106) placed beneath multilayer compression bandaging. The silver dressings included in the trial were aquacel ag, acticoat, acticoat 7, acticoat absorbent, Contreet foam and Urgotul SSD. The primary outcome measure was complete ulcer healing at 12 weeks. Secondary outcomes were time to healing, quality of life and cost effectiveness. no statistically significant differences between dressings in the proportion of ulcers healed at 12 weeks were detected (59.6% of ulcers healed with silver dressings compared with 56.7% for control dressings). Mean utility scores for the euroQol 5D and Short form 6D (quality-of-life measures) were similar in both groups at one, three, six and 12 months. in comparison with the control group, the antimicrobial group had an incremental cost of £97.85 and a quality-adjusted life year
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Art & science tissue viability supplement (QaLY) gain of 0.0002, giving an incremental cost-effectiveness ratio of £489,250 for the silver-containing dressings. This far exceeds the cost-effectiveness threshold considered acceptable by niCe (2007), which is £30,000 per QaLY. no significant differences were detected between dressing types for either primary or secondary endpoints. Therefore, Michaels et al (2009) concluded that there was no evidence to support the routine use of silver dressings beneath compression bandaging for venous ulceration, and that the least expensive non-silver dressings should be used (Michaels et al 2009).
Study flaws
Several flaws have been identified in Michaels et al’s (2009) study. it should be appreciated that leg ulcers in the active treatment group showed no signs of infection or critical colonisation; hence the cost-effectiveness analysis only demonstrates that the silver dressings were not effective or financially feasible when used in the treatment of uninfected wounds (gottrup and apelqvist 2010, White et al 2010, Leaper and Drake 2011). Therefore, the cost effectiveness of silver dressings in patients with infected ulcers is unproven, not because the analysis found them to be non-cost effective, but because the dressings were not necessarily applied to infected wounds. as silver dressings are only indicated for use in infected wounds, it might be said that the findings of this trial, in regard to cost effectiveness, are meaningless since the dressings were not used in accordance with the manufacture’s instructions nor recommendations in the Bnf (2012), which states that dressings containing silver should be used only when symptoms or clinical signs of infection are present. it is the opinion of the authors, as well as others (gottrup and apelqvist 2010, White et al 2010), that the Michaels et al (2009) study has methodological flaws, the most important of which is the use of silver-based antimicrobial dressings for prolonged periods of time (up to 12 weeks) without clinical justification, and contrary to best practice guidance (european Wound Management association 2006, World Union Wound healing Societies 2008). This has led to the mistaken belief that silver dressings performed in a similar manner to non-silver dressings that were purchased at a lower unit cost. as with all antimicrobials, it is paramount that silver-based dressings are used in an appropriate and structured manner for brief periods, with clear clinical objectives. This was 56 july 10 :: vol 27 no 45 :: 2013
not the case in Michaels et al’s (2009) study and as such its findings and recommendations should be viewed with a degree of caution.
Jeffcoate et al (2009) study in one rCT, Jeffcoate et al (2009) compared clinical effectiveness and cost effectiveness of three dressing products widely used in the routine management of diabetic wounds in the UK. a total of 317 patients with diabetic foot ulcers were randomised to one of three treatment arms within the study. The dressings under consideration were two traditional preparations: a non-adherent, knitted, viscose filament gauze product (n-a) and an iodine-impregnated dressing (inadine), and an advanced dressing of higher unit cost (aquacel). no significant differences between the three dressings were noted in terms of the proportion of ulcers healed by 12 or 24 weeks, or in mean time to healing. There were also no significant differences in the incidence of adverse events or quality of healing. in the health economic analysis, the cost of aquacel was significantly higher than that of the other two dressings (mean cost per patient: n-a £14.85, inadine £17.48, aquacel £43.60). Jeffcoate et al (2009) concluded that the use of the cheaper dressings could generate savings to the nhS of £1 million over a six-month period. This has significant implications for the treatment of patients within a health service struggling to meet financial demands and funding cuts. however, close review of the study reveals several flaws that raise concerns about its validity.
Study flaws
all effective studies are constructed to take into account that some subjects may withdraw from the study before its completion. The study protocol developed by Jeffcoate et al (2009) was designed for a maximum withdrawal rate of 25%. however, this rate was exceeded (withdrawal rate of 28%), and there were differences in the rates between treatment groups, affecting the analysis and final results. Compared to the other two dressings, the n-a dressing treatment group had the highest withdrawal rate; mostly because of adverse events and protocol violations. This may have led to the clinical outcomes in the n-a group appearing somewhat better than they were in practice. Jeffcoate et al (2009) stated that there were no observed differences in effectiveness between the dressings. however, the data show that there were differences in healing, particularly in
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larger ulcers (>100 mm3) managed with hydrofibre compared with n-a, although it was stated that these differences were not statistically significant. This is unsurprising given the issues relating to study withdrawal rate and frequency of dressing change. The study protocol specified that dressings should be changed daily, on alternate days or three times per week. Since the protocol specified a minimum of dressing changes three times per week, differences in dressing wear time between treatment groups will have been minimised. This significantly disadvantages the hydrofibre dressing group (this product is indicated for up to seven-day wear, unlike the iodine and n-a dressings), and is important as the number of dressings used was included within the economic analysis. Jeffcoate et al (2009) did not take full account of the significantly fewer dressing changes made by medical professionals required with the advanced dressing. The study found that almost 70% of all dressing changes were undertaken by non-professionals and that there were no differences in the use of professional time between the three treatment groups. This is in stark contrast with the data gathered in respect to the number of trial dressings used by professionals during the intervention phase of the study. This revealed a significant difference between groups, with aquacel being changed least often (P = 0.025) when dressing changes were performed by professionals only. it is recognised that non-professionals might have changed aquacel dressings more frequently than professionals would have done. Jeffcoate et al (2009) noted that ‘although the overall mean (and median) number of dressings used was lower for aquacel than for the other two products (and the difference between groups was statistically significant), there was no such difference between groups in the frequency of dressing changes performed when participants or carers were involved in dressing changes’. Therefore, Jeffcoate et al (2009) acknowledged that conclusions based on the cost effectiveness of one or other product are limited in practice by whether or not, or how often, dressing changes are reliant on the input of professionals. Jeffcoate et al (2009) concluded that the least costly of the three dressings (n-a) should be used more widely for the management of diabetic foot ulcers. however, this fails to acknowledge the issues of patient and informal carer influence on the health-economic analysis of the study. The findings also contradict international guidelines, published by many
of the world’s leading experts in diabetic foot disease, which recommend a moist wound environment to achieve better healing outcomes in the treatment of diabetic foot ulcers (Brem et al 2006, Dinh and Veves 2006, Snyder and hanft 2009, Vuorisalo et al 2009).
Discussion The rCT studies by Michaels et al (2009) and Jeffcoate et al (2009) question the use of silver-based dressings and other advanced wound products in the treatment of venous leg ulceration and diabetic foot ulcers, respectively. if the findings of the studies are accepted in isolation of other study results and clinical experience from these areas, it would appear that substantial savings in health care could be achieved. however, these studies fail to provide guidance to the clinician as they do not address adequately key areas of concern and, because of flawed methodology, make inconsistent and inaccurate recommendations.
Silver-based dressing use
The increase in the use of silver-based dressings has been an area of concern for senior clinicians and managers in recent years. for the clinician, concern has focused on whether silver is an effective method of bacterial control and if it has the potential to select for resistance or invoke systemic toxicity (Percival et al 2005, Loh et al 2009, Wang et al 2009). Michaels et al’s (2009) study addresses none of these issues; instead it suggests that the use of silver dressings has no place in wound management on the grounds of equivalency with other dressings in respect of healing outcomes, and its substantially higher cost. The methodology of this study and the conclusions drawn are open to criticism; most notably on the grounds that patients were allocated either silver or non-silver treatments randomly, so a large number of people received antimicrobial therapy without clinical justification (Timmons 2010). on this basis, the conduct and findings of the study are flawed. The results, including the quality of life and health economic components, should be interpreted in light of these flaws and are, therefore, of questionable value. The failure of others to recognise and acknowledge the shortcomings of the study is disappointing and serves no constructive purpose (Drug and Therapeutics Bulletin 2010, Lo 2010). it is widely accepted that the use of silver-based dressings needs to be controlled. indiscriminate use of any antimicrobial cannot be justified.
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Art & science tissue viability supplement This has been articulated by multidisciplinary expert panels, assembled to derive a best practice statement for the use of topical antiseptics (Wounds UK 2010, 2011), and an international consensus panel (international Consensus 2012). The use of such treatments in wounds that are not critically colonised (Cooper 2005) or in the absence of signs and symptoms of infection (Cutting and harding 1994, Cutting 1998, gardner et al 2001) is unacceptable. a ‘just in case’ approach to the prescription of antimicrobial dressings should be discouraged, except where justified clinically in defined at-risk patients. research-based recommendations rationalising the use of silver and other topical antimicrobials in clinical practice have been published. Sibbald et al (2005) compared the findings of rCTs with those of real-life situations and concluded that silver-based antimicrobial dressings, specifically sustained-release silver foams, are of particular benefit in the treatment of critically colonised wounds.
Diabetic foot management
The cost-effective management of diabetic foot ulcers is a high priority in the UK, particularly given the rise in diabetes, and the financial and personal costs associated with these wounds (Kerr 2012). Treatment regimens need to be clinically effective and cost efficient. Jeffcoate et al (2009) suggested that the use of advanced dressings does not produce any greater positive endpoints in terms of clinical effectiveness or cost effectiveness. however, as has been shown, this study has methodological flaws that call the value of the findings into question. an important advantage of advanced dressings, as evident from comparative trials and case series, is that in competent hands they require fewer changes, which consequently offsets the higher initial costs (Motta 1989, armstrong and ruckley 1997, Brem et al 2006, gravante et al 2009, Lo 2010, Wounds UK 2010). advanced dressings are essentially less labour-intensive and provide equally effective, if not better, clinical results than traditional dressings, most notably following education of clinicians (Dinh and Veves 2006, Smith et al 2010). in addition, the benefits to the patient include improved quality of life and the opportunity to pursue normal activities of daily living, such as returning to employment. in short-term studies considering cost analysis, such as that conducted by Jeffcoate et al (2009), many of these long-term economic benefits are overlooked.
one approach to managing healthcare costs is to involve the patient and/or his or her informal carer in wound care. as Jeffcoate et al (2009) stated: ‘option to involve patients and non-professional carers needs to be assessed more formally and could be associated with significant reductions in healthcare costs.’ While patient and informal carer involvement in dressing changes may be economically viable in the short term, it cannot be claimed to be quality care, nor is it likely to be effective in reducing morbidity. although Jeffcoate et al (2009) concluded that the higher cost of aquacel was not offset by the need for fewer dressing changes, they conceded that ‘…older products, such as n-a and inadine, are generally changed more often than newer products, thereby potentially involving an increased amount and cost of professional time’ (Jeffcoate et al 2009). however, the frequency of dressing changes in the study was set to meet the limitations of the traditional dressings rather than to optimise the benefits of the advanced dressing. in addition, the reliance of non-professionals in the management of wounds would inevitably result in a less than optimal use of dressing resources as these individuals do not have the experience, training or insight to adjust treatment protocols to match changes in wound status. This results in dressing wastage, which cannot be interpreted as a clinical need for more frequent dressing changes. given that the studies by Michaels et al (2009) and Jeffcoate et al (2009) have methodological flaws, it is somewhat surprising that their recommendations have influenced decision making and clinical practice. Without further investigation, the exact reasons for this are difficult to identify, although there may be several possible explanations. The first explanation, and possibly the most important among clinicians, is that these studies were rCTs conducted by experts in the field of wound care, and their recommendations may have been accepted without question. Many clinicians lack the skills to evaluate research. even those eminent in the field of wound care can enter into studies that have failed to identify appropriate end points (Leaper 2009a). Perceived expertise is no guarantee that a study will be methodologically sound or that its recommendations are clinically appropriate. Therefore, all research should be considered and appraised carefully. The studies examined in this article were independently funded through the nhS at a cost of £583,459 for the Michaels et al (2009) and
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Art & science tissue viability supplement £676,823 for the Jeffcoate et al (2009) study. as there is a paucity of funding to support research in the nhS, many studies rely on commercial sponsorship to cover the cost of undertaking the work. although safeguards are usually put in place to ensure that the sponsor does not overtly influence the conduct of studies or their
findings and recommendations, there is always a concern that commercially sponsored research projects could have some degree of bias. as such, clinicians and health managers may be more likely to accept the findings of independently funded research over commercially sponsored studies, regardless of study rigour.
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The research may be used to support previously held beliefs or decision making. By providing evidence, however weak or flawed, that the use of advanced dressing products has no positive benefits, the studies by Michaels et al (2009) and Jeffcoate et al (2009) appear to uphold some clinicians’
International consensus (2012) Appropriate Use of Silver Dressings in Wounds. woundsinternational.com/pdf/ content_10381.pdf (Last accessed: June 18 2013.) Jeffcoate WJ, Price PE, Phillips CJ et al (2009) Randomised Controlled Trial of the Use of Three Dressing Preparations in the Management of Chronic Ulceration of the Foot in Diabetes. hta.ac.uk/fullmono/ mon1354.pdf (Last accessed: June 18 2013.) Jones J (2005) Winter’s concept of moist wound healing: a review of the evidence and impact on clinical practice. Journal of Wound Care. 14, 6, 273-276. Jones V, Grey JE, Harding KG (2006a) Wound dressings. In Grey JE, Harding KG (Eds) ABC of Wound Healing. BMJ Books, Oxford, 31-35. Jones AM, San Miguel L (2006b) Are modern wound dressings a clinical and cost-effective alternative to the use of gauze? Journal of Wound Care. 15, 2, 65-69. Jones V, Grey JE, Harding KG (2006c) Wound dressings. British Medical Journal. 332, 7544, 777-780. Jull A, Arroll B, Parag V, Waters J (2002) Pentoxifylline for treating venous leg ulcers. Cochrane Database of Systematic Reviews. Issue 3, CD001733. Kannon GA, Garrett AB (1995) Moist wound healing with occlusive dressings. A clinical review. Dermatologic Surgery. 21, 7, 583-590.
beliefs that industry-based studies are biased towards commercial gain. The findings of both studies support attempts to rationalise wound care options available to clinicians and, as such, support management decision making within UK austerity initiatives.
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Art & science tissue viability supplement Conclusion it is vital that those working in wound care aim to improve clinical and health-economic outcomes for patients and services through the application of research findings. all data, findings and recommendations should be examined thoroughly and critically. Professional
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journals have an important role in this process since one aspect of peer-review is to identify flawed publications. The findings of the studies examined in this article should be interpreted with caution and require closer analysis before forming the basis of clinical decision making NS
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