Wound centres-how do we obtain high quality? The EWMA wound centre endorsement project.

OBJECTIVE: Different types of multidisciplinary concepts for treating non-healing wounds have been developed. However, there is insufficient evidence on the quality of multidisciplinary wound centres, and a limited number of evaluation systems have so far been developed. The lack of an international wound centre evaluation/certification system is the basis for the European Wound Management Association (EWMA) Wound Centre Endorsement Project. The project aims to describe the minimum requirements for a wound management centre. These requirements have been defined as a basis for evaluation and endorsement of wound centres inside as well as outside a hospital setting (in- and outpatient clinics). METHOD: The endorsement programme focused on wound centre characteristics such as: target population; types of centres; and choice of model used. The method used to develop the EWMA wound centre endorsement programme was an evaluation of the quality of the different types of established wound centres across and outside Europe. Criteria and procedures for endorsement of wound centres were developed and pilot projects were performed outside Europe in two in-patient centres in China and one outpatient centre in Brazil. RESULTS: The EWMA endorsement procedure includes the following steps: initial application; review of centre data provided via the application form and follow-up dialogue; visit to the wound centre; final report and endorsement; and re-endorsement. A follow-up visit was arranged in connection with the re-endorsement. Experiences from the pilot studies have so far indicated that the endorsement process is not only a quality declaration, but may also result in positive developments, such as increased visibility, increased patient flow, increased healing rates, and decreased amputation rate. CONCLUSION: Development of endorsement systems focusing on the minimum requirements for a wound management centre is required to support the development of high-quality wound centres which provide health-care services according to recent evidence of current best practice. The EWMA Wound Centre Endorsement Project is the first international programme of its kind and this may, in the future, support the establishment of international collaboration and knowledge sharing about the development and maintenance of high-quality wound centres.

Antimicrobial stewardship in wound care: a Position Paper from the British Society for Antimicrobial Chemotherapy and European Wound Management Association.

BACKGROUND: With the growing global problem of antibiotic resistance it is crucial that clinicians use antibiotics wisely, which largely means following the principles of antimicrobial stewardship (AMS). Treatment of various types of wounds is one of the more common reasons for prescribing antibiotics. OBJECTIVES: This guidance document is aimed at providing clinicians an understanding of: the basic principles of why AMS is important in caring for patients with infected wounds; who should be involved in AMS; and how to conduct AMS for patients with infected wounds. METHODS: We assembled a group of experts in infectious diseases/clinical microbiology (from the British Society for Antimicrobial Chemotherapy) and wound management (from the European Wound Management Association) who, after thoroughly reviewing the available literature and holding teleconferences, jointly produced this guidance document. RESULTS: All open wounds will be colonized with bacteria, but antibiotic therapy is only required for those that are clinically infected. Therapy is usually empirical to start, but definitive therapy should be based on results of appropriately collected specimens for culture. When prescribed, it should be as narrowly focused, and administered for the shortest duration, as possible. AMS teams should be interdisciplinary, especially including specialists in infection and pharmacy, with input from administrative personnel, the treating clinicians and their patients. CONCLUSIONS: Available evidence is limited, but suggests that applying principles of AMS to the care of patients with wounds should help to reduce the unnecessary use of systemic or topical antibiotic therapy and ensure the safest and most clinically effective therapy for infected wounds.

Ewma Study Recommendations: For Clinical Investigations in Leg Ulcers and Wound Care.

In 2010, the EWMA Patient Outcome Group (POG) published recommendations to improve the quality of evidence in wound management. (1) As a companion piece of work, the EWMA POG has worked to provide a series of user-friendly documents to assist those new to (or inexperienced in) research, in starting on the path to plan, conduct, interpret and disseminate findings from an investigation that will improve our understanding of clinical wound healing and raise the evidence level of the work undertaken in this important area. Given the range of wound types that clinicians are involved with, the POG has decided to limit the first of these to venous leg ulcers. In addition, as a European association, the focus will be on EU regulations and directives.

Antimicrobials and Non-Healing Wounds. Evidence, controversies and suggestions-key messages.

This article constitutes an extraction of key messages originally presented in the Document: Antimicrobials and Non-Healing Wounds. Evidence, controversies and suggestions written by the European Wound Management Association (EWMA), and originally published by the Journal of Wound Care in 2013. All sections are shortened and some not included. For further details please refer to in the original document which can be downloaded via www.ewma.org .

Randomized controlled trial on collagen/oxidized regenerated cellulose/silver treatment.

Collagen/oxidized regenerated cellulose (ORC)/silver therapy has been designed to facilitate wound healing by normalizing the microenvironment and correcting biochemical imbalances in chronic wounds. The aim of this study was to compare collagen/ORC/silver therapy to control (standard treatment). Patients with diabetic foot ulcers were randomized to either collagen/ORC/silver (24) or control treatment (15). Wound area measurements and wound fluid samples were taken weekly. Protease levels were measured in wound fluid samples to investigate differences between responders (≥50% reduction in wound area by week 4) and nonresponders (<50% reduction in wound area by week 4). There were significantly more responders in the collagen/ORC/silver group compared with the control group (79% vs. 43%, p = 0.035). There were significantly fewer withdrawals from the study because of infection in the collagen/ORC/silver group compared with the control group (0% vs. 31%, p = 0.012). The sum of matrix metalloproteinase-9 and elastase concentration was higher in nonresponders compared with responders at baseline (p = 0.0705) and week 4 (p = 0.012). The results suggest that collagen/ORC/silver normalizes the wound microenvironment and protects against infection, resulting in improved wound healing. It was also demonstrated that measuring a combination of proteases may be a more relevant prognostic healing marker than any individual protease alone.

Present and new techniques and devices in the treatment of DFU: a critical review of evidence.

Management of foot ulcer in individuals with diabetes remains a major therapeutic challenge throughout the world. We performed a critical review of evidence of present and new techniques and devices in the treatment of diabetic foot ulcer. The golden standard for optimal evidence in the Cochrane system is level I - randomized controlled trials, and meta-analyses of several randomized controlled trials. Available evidence on different types of wound debridement; use of antimicrobials; use of dressings in wounds; topical negative pressure, hyperbaric oxygen treatment; electrical, electromagnetic, laser, shockwave, and ultrasound therapies; growth and cell biology factors; cell products and tissue engineering; bioengineered skin and skin grafts; and adjuvant therapies were evaluated. The results of this review show that there is limited evidence on the highest level to justify a change in routine clinical practice. There is a paucity of high-quality evidence, because the studies are often based on inadequate sample size, short follow-up, nonrandom allocation to treatment arms, nonblinded assessment of outcomes, poor description of control, and concurrent intervention. The heterogeneity of the population (of both people and ulcers), with multiple factors contributing to both ulcer onset and failure to heal, makes the trial design difficult in this field. Another fundamental reason for the lack of evidence is the general use of the outcome measure 'complete healing'. In conclusion, when the results of this updated review are taken together with those of the earlier reports, they provide limited evidence to justify a change in routine clinical practice. For this reason, there is an urgent need to increase the quality of clinical studies. A re-evaluation of which type of research is acceptable for producing evidence in the wound area may be important in the future.

Producing precise outcomes in randomized, controlled trials and clinical studies.

Evidence-based medicine (EBM) uses the current best evi- dence to inform decisions about care of individual patients, healthcare procedures, and technologies. The "gold standard" for optimal evidence in the Cochrane system is Level I randomized, controlled trials (RCTs) and meta-analyses of several RCTs. In order to achieve this level of evidence, one of the most important measures is the use of outcomes/ endpoints. This article will provide, in short form, recommendations on how to achieve rigorous endpoints or outcomes in studies on wound management. Consistency in measuring endpoints/outcomes improves quality of care. To achieve such consistency it is important to 1) use predefined and robust outcomes; 2) adapt outcomes to the interven- tion under investigation; and 3) use the best evidence available. Also, it is emphasized that the use of complete wound closure or healing as an outcome measure is not always possible or suitable. Remaining patient-focused clarifies which other endpoints are relevant. Finally, "basic care" must be clearly defined and standardized when used as a comparative intervention in a RCT. In conclusion, the use of correct, clinically relevant outcomes or endpoints is of vital importance when establishing optimal evidence in wound healing and care. 

A prospective, multi-centre, randomised, open label, parallel, comparative study to evaluate effects of AQUACEL® Ag and Urgotul® Silver dressing on healing of chronic venous leg ulcers.

This study compared wound healing efficacy of two silver dressings, AQUACEL(®) Ag and Urgotul(®) Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL(®) Ag to Urgotul(®) Silver. Patients (281) were randomised into two groups. The AQUACEL(®) Ag group had 145 patients treated with AQUACEL(®) Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul(®) Silver group had 136 patients treated with Urgotul(®) Silver for 4 weeks followed by Urgotul(®) for another 4 weeks. In both groups, ulcer size and depth, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL(®) Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul(®) Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL(®) Ag group to the Urgotul(®) Silver group was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval -6·56 to 20·2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL(®) Ag group had statistically higher percentage of subjects with better wound progression (66·9% versus 51·9%, P = 0·0108). In general, both dressings were effective at promoting healing of venous ulcers.

Latex medical gloves: time for a reappraisal.

Many hospitals have implemented policies to restrict or ban the use of devices made of natural rubber latex (NRL) in healthcare as precautionary measures against the perceived risk of NRL allergy. Changes in glove technology, progress in measuring the specific allergenic potential of gloves and a dramatic decrease in the prevalence of NRL allergies after interventions and education prompted us to revisit the basis for justifiable glove selection policies. The published Anglophone literature from 1990 to 2010 was reviewed for original articles and reviews dealing with the barrier and performance properties of NRL and synthetic gloves and the role of glove powder. The review shows that NRL medical gloves, when compared with synthetic gloves, tend to be stronger, more flexible and better accepted by clinicians. The introduction of powder-free gloves has been associated with reductions in protein content and associated allergies. Recently, new methods to quantify clinically relevant NRL allergens have enabled the identification of gloves with low allergenic potential. The use of low-protein, low-allergenic, powder-free gloves is associated with a significant decrease in the prevalence of type I allergic reactions to NRL among healthcare workers. Given the excellent barrier properties and operating characteristics, dramatically reduced incidences of allergic reactions, availability of specific tests for selection of low-allergen gloves, competitive costs and low environmental impact, the use of NRL gloves within the hospital environment warrants reappraisal.

The effect of honey-coated bandages compared with silver-coated bandages on treatment of malignant wounds-a randomized study.

Malignant wounds (MWs) occur in 5-10% of all cancer patients. Malodor and exudation are the most common side effects. The aim was to determine the influence of honey-coated compared with silver-coated bandages on treatment of MWs. Patients were randomly selected to enter either group A (honey-coated bandages) or group B (silver-coated bandages). Parameters were the following: wound size, cleanliness, malodor, exudation, and wound pain. Digital photographs, visual analog scales (VAS), and wound morphology registration were used for measurement at baseline and following the 4-week intervention. Sixty-nine patients with MWs and advanced cancer, aged 47-90 (median 65.6), were included. No statistically significant difference was noted between the groups with respect to wound size, degree of cleanliness, exudation, malodor, and wound pain. There was a median decrease in wound size of 15 cm² and 8 cm² in group A and B, respectively (p = 0.63). Based on post-intervention pooled data from the groups, improvement was seen in 62% of the participants with respect to wound size and in 58% (n = 69) with respect to cleanliness. The VAS score for malodor (p = 0.007) and exudation (p < 0.0001) improved significantly post-intervention. Patients with reduced wound size had a median survival time of 387 days compared with 134 days in patients with no wound reduction (p = 0.003). The use of honey-coated and silver-coated bandages improved the outcome of MWs. No differences were found between the two regimens. Both types of bandages are recommended for use by patients with MWs containing tumor debris and necrosis.

Smoking attenuates wound inflammation and proliferation while smoking cessation restores inflammation but not proliferation.

Full-thickness 5 mm punch biopsy wounds were made lateral to the sacrum in 48 smokers and 30 never smokers. After 1 week, the wounds were excised and fixed. The smokers were then randomized to continuous smoking or abstinence with a transdermal nicotine patch or a placebo patch. The sequence of wounding and excision was repeated after 4, 8, and 12 weeks. All excised tissue was stained with hematoxylin-eosin and immunohistochemically for macrophages (CD68), procollagen 1 N-terminal propeptide (PINP) in fibroblasts, and endothelial cells (CD31). The cellularity was assessed and scored by two independent histopathologists, and for the analysis, proportional odds models and random effect models for repeated measurements were applied. Macrophages and PINP-stained fibroblasts were reduced in the smokers' wounds (0.28 [0.14-0.58] [OR, 95%CI]; p=0.01 and 0.37[0.19-0.70]; p<0.01, respectively, when compared with never smokers' wounds). Inflammation scores were marginally affected. Following smoking cessation, inflammatory cell infiltration and macrophages in the wounds increased. PINP-stained fibroblasts were unaffected. Neovascularization was not affected by smoking or abstinence. Wound inflammation and fibroblast proliferation were attenuated in smokers, suggesting delayed healing. Abstinence from smoking restores inflammation, but does not affect proliferation. These findings suggest a pathophysiologic mechanism for postoperative wound infection and dehiscence in smokers and why smoking cessation appears to reduce wound infection but not dehiscence.

Acute effects of nicotine and smoking on blood flow, tissue oxygen, and aerobe metabolism of the skin and subcutis.

BACKGROUND: Nicotine released from tobacco smoke causing reduction in blood flow has been suggested as causative for postoperative wound complications in smokers, but the mechanism remains unknown. MATERIALS AND METHODS: In eight healthy male smokers and eight ex-smokers, the cutaneous and subcutaneous blood flow (QBF, SqBF) was assessed by Laser Doppler and 133Xe clearance. Tissue oxygen tension (TO(2)) was measured by a LICOX O(2)-electrode. Tissue glucose and lactate (Tgluc, Tlact) were assessed by microdialysis. The parameters were studied after intravenous infusion of 1.0 mg nicotine, smoking of one cigarette, arterial occlusion, and reperfusion. RESULTS: Nicotine infusion decreased SqBF from 4.2 +/- 2.0 to 3.1 +/- 1.2 mL/100 g tissue/min (P < 0.01), whereas QBF was 21.7 +/- 8.6 and 22.7 +/- 9.6 Arbitrary Units (AU), respectively (P = 0.21). TO(2) increased from 49.3 +/- 12.0 to 53.9 +/- 12.0 mm Hg (P = 0.01). Tgluc and Tlact remained unaffected. Smoking decreased SqBF from 4.2 +/- 2.0 to 2.7 +/- 1.2 mL/100 g tissue/min (P < 0.01). QBF decreased from 23.4 +/- 9.2 to 20.3 +/- 7.4 AU (P < 0.01), and TO(2) decreased from 53.9 +/- 12.0 to 48.4 +/- 11.1 mm Hg (P < 0.01). Following smoking, Tgluc decreased from 0.7 +/- 0.1 to 0.6 +/- 0.1 ng/mL (P < 0.01), and Tlact increased from 0.2 +/- 0.1 to 0.3 +/- 0.2 ng/mL (P < 0.01). The observed alterations were similar in smokers and ex-smokers. CONCLUSIONS: Nicotine has a limited vasoactive effect in the skin and subcutis unlikely to be explained by smoking, which distinctly decreases tissue blood flow, oxygen tension, and aerobe metabolism independent of smoking status.

Effect of smoking, abstention, and nicotine patch on epidermal healing and collagenase in skin transudate.

Delayed wound healing may explain postoperative tissue and wound dehiscence in smokers, but the effects of smoking and smoking cessation on the cellular mechanisms remain unclear. Suction blisters were raised in 48 smokers and 30 never smokers. The fluid was retrieved and the epidermal roof was excised. Transepidermal water loss (TEWL) was measured after 2, 4, and 7 days. Then, the smokers were randomized to continuous smoking or abstinence with a transdermal nicotine patch or a placebo by concealed allocation. The sequence was repeated after 4, 8, and 12 weeks in all smokers and abstainers and in 6 never smokers. Matrix metalloproteinase (MMP)-8 and MMP-1 levels in suction blister fluid were assessed by an enzyme-linked immunosorbent assay. Random-effects models for repeated measurements were applied and p< or =0.05 was considered significant. One week after wounding the TEWL was 17.20 (14.47-19.92) g/cm(2) hour (mean, 95% CI) in smokers and 13.89 (9.46-18.33) in never smokers (p<0.01). In abstinent smokers TEWL was 18.95 (15.20-22.70)(p<0.01, when compared with smokers). In smokers, MMP-8 was 36.4 (24.3-48.5) ng/mL (mean, 95% CI) and 15.2 (1.4-30.2) ng/mL in never smokers (p<0.01). Abstinent smokers' MMP-8 level was 21.2 ng/mL (6.6-43.0) (p=0.02, when compared with smokers). MMP-1 was unaffected by smoking and abstention. Transdermal nicotine patch did not affect any parameter. We conclude that smoking attenuates epidermal healing and may enhance extracellular matrix degradation. Three months of abstinence from smoking does not restore epidermal healing, whereas 4 weeks of abstinence normalizes suction blister MMP-8 levels. These findings suggest sustained impaired wound healing in smokers and potential reversibility of extracellular matrix degradation.

Human skin wounds: a major and snowballing threat to public health and the economy.

ABSTRACT In the United States, chronic wounds affect 6.5 million patients. An estimated excess of US$25 billion is spent annually on treatment of chronic wounds and the burden is rapidly growing due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity worldwide. The annual wound care products market is projected to reach $15.3 billion by 2010. Chronic wounds are rarely seen in individuals who are otherwise healthy. In fact, chronic wound patients frequently suffer from "highly branded" diseases such as diabetes and obesity. This seems to have overshadowed the significance of wounds per se as a major health problem. For example, NIH's Research Portfolio Online Reporting Tool (RePORT; http://report.nih.gov/), directed at providing access to estimates of funding for various disease conditions does list several rare diseases but does not list wounds. Forty million inpatient surgical procedures were performed in the United States in 2000, followed closely by 31.5 million outpatient surgeries. The need for post-surgical wound care is sharply on the rise. Emergency wound care in an acute setting has major significance not only in a war setting but also in homeland preparedness against natural disasters as well as against terrorism attacks. An additional burden of wound healing is the problem of skin scarring, a $12 billion annual market. The immense economic and social impact of wounds in our society calls for allocation of a higher level of attention and resources to understand biological mechanisms underlying cutaneous wound complications.

Reducing wound pain in venous leg ulcers with Biatain Ibu: a randomized, controlled double-blind clinical investigation on the performance and safety.

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43-47, the patients in the ibuprofen-foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low-dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.

Leg ulcers: uncommon presentations.

Uncommon presentations like vasculitis or other immunologic causes and malignancy account for about 1% to 2% of patients suffering from leg ulcers. We focus on such uncommon leg ulcers including: cutaneous vasculitis causing cutaneous ulceration, other immunologic or metabolic cutaneous lesions such as pyoderma gangrenosum and necrobiosis lipoidica, and ulcers based on neoplastic etiology. A short description on leg ulcers in the tropics is also included. The described uncommon presentations of leg ulcers are typically difficult to diagnose and treat; it is a specialist's job to take care of patients with these types of ulcers. Multidisciplinary specialized wound healing concepts integrated in the national health care system, as an accepted expert function, is the ideal way to organize the wound healing area. Such a system would result in an earlier diagnosis and more sufficient treatment for patients with uncommon presentations of leg ulcers.