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.

Chronic Ulceration and Sinus Formation due to Foreign Body: An Often-Forgotten Problem.

Foreign bodies like residues of suture or mesh may lead to a foreign body reaction, cavity formation and continuous secretion and perhaps ulceration. We present a more than 9 years long medical record of a 49 year old man after a simple surgical procedure. The background was a sinus formation generated from a foreign body reaction. The case report shows that this condition is often overlooked and even using advanced equipment, it is difficult to diagnose. The only solution is to diagnose and remove the triggering cause. Fistulography and ultrasound scanning seem to be the optimal diagnostic tool in these cases. The knowledge of the foreign body reaction in tissue continuously needs to be reestablished in the health care system especially in areas, where implantation of foreign material is used.

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 .

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.

The use of biatain Ag in hard-to-heal venous leg ulcers: meta-analysis of randomised controlled trials.

BACKGROUND: Venous leg ulcers are common, troublesome, and their failure to heal is often related to a heavy bio-burden. Ionized silver has both anti-inflammatory and antimicrobial properties. The ulcer healing properties of the silver releasing foam dressing Biatain Ag has been examined in 4 randomized controlled trials (RCTs). AIM: To evaluate ulcer healing through a meta-analytic approach after treatment with either Biatain Ag or a non-active dressing. PATIENTS AND METHODS: 685 subjects with pure or mixed hard-to-heal venous leg ulcers were included in the meta-analysis. RESULTS: Biatain Ag showed a significant treatment effect (p<0.0001), responder rate (p<0.001), and healing rate (p = 0.002). CONCLUSION: The meta-analysis of the 4 RCTs provided statistical significant evidence to support the use of Biatain Ag dressing in treatment of hard-to-heal venous leg ulcers.

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.

Education in Wound Management in Europe with a Special Focus on the Danish Model.

BACKGROUND: Standardized education and training programs are fundamental for the establishment of a healthcare structure within wound management. THE PROBLEM: Presently, however, wound healing education is only included to a minor degree, in the education of nurses and medical doctors, and there is no consensus in Europe on the minimum education program needed to be an educated expert in handling wound patients. CLINICAL CARE RELEVANCE: In this article, educational initiatives and models for education of medical doctors and nurses in Europe and especially in Denmark are described. CONCLUSION: The goal for the future should be to achieve a general consensus on the minimal education program, and in Europe this could be achieved as a collaboration between the Educational program of European Wound Management Association (EWMA and national programs).

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.

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.

Qualitative bacteriology in malignant wounds--a prospective, randomized, clinical study to compare the effect of honey and silver dressings.

 Between 5% and 10% of cancer patients develop malignant wounds. In vitro and some clinical studies suggest that silver- or honey-coated dressings may have an antibacterial effect in nonmalignant wounds, but their possible antibacterial effect in malignant wounds remains unknown. A prospective, randomized, single-blind controlled clinical study was conducted to evaluate the bacteriology of malignant wounds and compare the effect of a honey-coated (Group A) to a silver-coated (Group B) dressing on the qualitative bacteriology of malignant wounds. All wound interventions were performed by the same healthcare professional. Swab cultures were obtained at baseline and following a 4-week intervention and were evaluated without information about the patient treatment group. Of the 75 patients with advanced cancer and malignant wounds identified, 67 (34 in group A, 33 in group B; median age 64 years, range 47-92) consented to participate and completed the 4-week study. The majority were women (88%) with breast cancer (79%). No statistically significant differences were found between the type and number of different wound pathogens in the wounds during the course of the study or between Group A and Group B. Neither anti-neoplastic nor antibiotic treatment influenced the presence of wound pathogens. Staphylococci were found in 42%, enteric bacteria in 34%, anaerobic bacteria in 16%, Pseudomonas in 10%, and hemolytic streptococci in 6% of wounds at baseline; in total, 25 different bacterial species were identified. Sixty-one percent (61%) of wounds decreased in size following treatment, but no significant differences were observed between the type and variety of wound pathogens and whether wound size decreased. Although quantitative bacteriological changes may have occurred, the possible antibacterial effect of the honey or silver dressing could not be confirmed in these malignant wounds. Routine wound swabbing of malignant wounds is of little value and should be restricted to cases where signs of infection requiring antibiotic intervention are observed or where resistant organisms require special infection control measures.

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.

Maggot debridement: an alternative method for debridement.

UNLABELLED: Debridement is an essential component to promote healing in a problem wound. Several techniques are available including maggot debridement therapy (MDT). OBJECTIVE: To describe the efficacy of MDT for treating problem wound especially diabetic foot ulcers. METHODS: The topic is elucidated from different points of view: the mode of action, when to use, use in a practice, clinical results, and discussing the problem of creating evidence for the clinical effect. RESULTS: Literature and own results demonstrate that MDT is a safe method with few side effects. Maggot debridement therapy is as good as or better than conventional often surgical debridement, is more selective than surgical debridement, decreases time to healing and stay of patients in the ward, and may decrease the risk of major amputations. However, the evidence of these effects of MDT on the highest level is presently lacking. A detailed description of how to use MDT in practice is provided including a visual demonstration in a video. CONCLUSION: In spite of lacking clinical evidence, MDT clinical experience strongly suggests that this technique is effective and safe. It can be used for most types of problem wounds, but our indication is primarily diabetic foot ulcers, because of its selectivity for debriding necrotic dead tissue. It may be a valuable alternative surgical/sharp debridement.

An avalanche of ignoring--a qualitative study of health care avoidance in women with malignant breast cancer wounds.

BACKGROUND: A contributing factor to development of malignant wounds is patient-related delay caused by health care avoidance. OBJECTIVE: The purpose of this study was to describe the experience of health care avoidance in women with advanced breast cancer who have developed malignant wounds. METHODS: A qualitative study was conducted based on semistructured interviews. Seventeen women with advanced breast cancer (median age, 69 years; range, 47-90 years) who had avoided medical treatment despite development of malignant wounds participated. Systematic text-condensation analysis was used. RESULTS: The women deliberately avoided health care for a median of 24 months (minimum, 3 months; maximum, 84 months). Despite being aware of the development of a malignant wound from a breast lump, the women avoided health care because of negative health care experiences and extremely burdening life situations. The women did not seek health care until their situations became unmanageable. The essence--"an avalanche of ignoring"--is pointing to the escalating, powerful development of destructive feelings behind health care avoidance. CONCLUSIONS: Health care avoidance may be a way of coping both for women who are primary and/or bereaved caregivers. Oncologists and nurses may contribute to the prevention hereof by means of information about the early signs of cancer, benefits of early diagnosis and treatment, and by paying special attention to these women, who may be at high risk for avoidant behaviors. IMPLICATIONS FOR PRACTICE: In a preventive perspective, it seems advantageous to bring into focus the health of primary and bereaved caregivers, thereby potentially reducing patient delay and ultimately improving survival.