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* There is a need for evidence to support the use of dressings containing silver in the management of critically colonised wounds.
* In wound care, a new model needs to bridge the gap between the ideal and reality. This could be used to critically evaluate specific treatment procedures where there is only limited clinical and investigational evidence to support their use.
* The use of an evidence-based medicine model can provide a framework for future analysis of the efficacy (clinical studies), efficiency (everyday practice) and effectiveness (relative cost) of new technologies in wound care.
Abstract
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This paper presents clinical evidence on a sustained-release silver foam dressing in chronic wounds with regard to efficacy, efficiency and effectiveness of evidence-based medicine. The results are derived from a randomised, controlled, clinical trial (efficacy), a real-life, randomised comparative study from everyday practice (efficiency), and a health-economic evaluation (effectiveness). The results indicate that this sustained-release silver foam dressing provides particular benefit for the treatment of critically colonised wounds. It is suggested that the use of the evidence-based medicine model may be a benchmark for a new level of clinical evidence in wound management.
BACKGROUND: Foot ulceration affects 15-20% of people with diabetes. It is a major precursor to amputation in this patient group, and early and appropriate treatment provides the greatest opportunity for healing. The use of silver for its antimicrobial properties has re-emerged, and modern wound dressings that release a sustained amount of free silver ions, are now widely used in wound management.
OBJECTIVES: To evaluate the effects of silver-containing dressings and topical agents on infection rates and healing of diabetes related foot ulcers.
SEARCH STRATEGY: Searches were made of the Cochrane Wounds Group Specialised Register (August 2005), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3 2005) MEDLINE (1966 to October week 2 2004), EMBASE (1980 to October week 2 2004) and CINAHL (1982 to October week 2 2004). The Journal of Wound Care (Volume 12/13 Issues 1-10) was hand-searched. Manufacturers, researchers and local and international wound groups were contacted in order to identify unpublished trials. Web sites for wound groups and World Wide Wounds (www.worldwidewounds.com) were searched.
SELECTION CRITERIA: Randomised controlled trials and non-randomised controlled clinical trials were considered for inclusion. Studies were included if they involved participants with Type 1 or Type 2 diabetes and related foot ulcers, met the requirements for randomisation, allocation and concealment where appropriate, and compared the intervention with a placebo or a sham dressing, an alternative non silver based dressing or no dressing, and reported outcomes that represent healing rate or infection.
DATA COLLECTION AND ANALYSIS: Two authors independently evaluated the papers identified by the search strategy against the inclusion criteria but identified no trials eligible for inclusion in the review. It was not possible to perform planned subgroup and sensitivity analysis in the absence of data. In future, if eligible trials become available, a random effects model will be applied for meta-analysis in the presence of statistical heterogeneity (estimated using the I(2) statistic). Dichotomous outcomes will be reported as risk ratios with 95% confidence intervals (CI), and continuous outcomes as weighted mean differences (WMD) with 95% CI. Statistical significance will be set at P value < 0.05 for all outcomes and the magnitude of the effect will be estimated by calculating the number needed to treat (NNT) with 95% CI.
MAIN RESULTS: No studies were identified that met with the inclusion criteria
AUTHORS' CONCLUSIONS: Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Trials are needed to determine clinical and cost-effectiveness and long term outcomes including adverse events.
Prospective randomized controlled study of Hydrofiber® dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers
E. B. Jude J. Apelqvist M. Spraul J. Martini The Silver Dressing Study Group Diabetic Medicine 24 (3), 280–288.
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Aims Diabetic foot ulcers (DFUs) are at risk of infection and impaired healing, placing patients at risk of lower extremity amputation. DFU care requires debridement and dressings. A prospective, multicentre study compared clinical efficacy and safety of AQUACEL® Hydrofiber® dressings containing ionic silver (AQAg) with those of Algosteril® calcium alginate (CA) dressings in managing out-patients with Type 1 or 2 diabetes mellitus and non-ischaemic Wagner Grade 1 or 2 DFUs.
Methods Patients stratified by antibiotic use on enrolment were randomly assigned to similar protocols including off-loading, AQAg (n = 67) or CA (n = 67) primary dressings and secondary foam dressings for 8 weeks or until healing. Clinical efficacy measures were healing outcomes and primarily healing speed. Adverse events were recorded.
Results AQAg and CA groups were comparable at baseline. All ulcer healing outcomes improved in both groups. The mean time to healing was 53 days for AQAg ulcers and 58 days for CA ulcers (P = 0.34). AQAg-treated ulcers reduced in depth nearly twice as much as CA-treated ulcers (0.25 cm vs. 0.13 cm; P = 0.04). There was more overall ulcer improvement and less deterioration in AQAg subjects (P = 0.058), particularly in the subset initially using antibiotics (P = 0.02). Safety profiles of both groups were similar.
Conclusion When added to standard care with appropriate off-loading, AQAg silver dressings were associated with favourable clinical outcomes compared with CA dressings, specifically in ulcer depth reduction and in infected ulcers requiring antibiotic treatment. This study reports the first significant clinical effects of a primary wound dressing containing silver on DFU healing.
Prevalence of silver resistance in bacteria isolated from diabetic foot ulcers and efficacy of silver-containing wound dressings.
Percival SL, Woods E, Nutekpor M, Bowler P, Radford A, Cochrane C. Ostomy Wound Manage. 2008 Mar;54(3):30-40
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Silver dressings are used to manage wounds at risk of infection or locally infected. This in vitro study was conducted to assess the prevalence of silver resistance genes in 112 bacterial isolates obtained from the diabetic foot ulcers of patients attending the Diabetic Foot Clinic at Tameside General Hospital, UK. Using polymerase chain reaction to screen for three silver-resistance transcriptional units - silE, silS and silP - two silver-resistant bacteria were identified; both are strains of Enterobacter cloacae, an organism rarely implicated as a primary pathogen in chronic wounds. No recognized wound pathogens (Staphylococcus aureus - 24 isolates and Pseudomonas aeruginosa - nine isolates) were found to contain silver-resistant genes. Analysis of the efficacy of silver-containing dressings on the silver-resistant strains of Enterobacter cloacae using confocal laser microscopy showed that, despite evidence of genetic resistance to silver, all strains were killed following a maximum of 48 hours of exposure to the dressings. Results suggest that presence of silver resistance genes is rare and that genetic resistance does not necessarily translate to phenotypic resistance to silver. While silver resistance in wound care should be monitored, the threat of widespread resistance is low and silver-containing dressings remain an extremely important tool in managing wound infection.
A systematic review of silver-releasing dressings in the management of infected chronic wounds.
Lo SF, Hayter M, Chang CJ, Hu WY, Lee LL. J Clin Nurs. 2008 Aug;17(15):1973-85.
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AIM: This paper is a systematic review with the objective of determining the effectiveness of silver-releasing dressing in the management of infected chronic wounds. BACKGROUND: Chronic wounds exhibit increased bacterial burdens which not only result in a negative physical impact on patients, impairing their quality of life, but also increase treatment costs. Silver dressings are wound products designed to control and inhibit infection and provide a wound environment conducive to healing. However, there is limited evidence on their effectiveness in doing so.
METHODS: A systematic review of literature from 1950-May 2007 was conducted using the PubMed, CINAHL, Cochrane, MEDLINE, British Nursing Index, EBSCO Host, OCLC, Proquest and PsychInfo databases. The review included randomised or non-randomised control trials, published in English or non-English, of silver-releasing dressings in infected chronic wounds.
RESULTS: Of the over 1957 potentially releasing studies examined, 14 pertinent articles involving 1285 participants were identified. Almost all the participants reported one or more statistically significant outcomes. The main points to emerge from this review of studies are that silver-releasing dressings show positive effects on infected chronic wounds. The quality of the trials was limited by the potential for bias associated with inadequate concealment, no detailed description of the outcome measurement and no reported intention-to-treat analysis. Moreover, problems existed in some studies with confounding factors.
CONCLUSION: The review clearly highlights the need for well-designed, methodologically standardised outcome measurement research into the effectiveness of silver-releasing dressings. It also points to the need for a comprehensive assessment of wound bed status in further studies.
RELEVANCE TO CLINICAL PRACTICE: This review strengthens the case for the use of silver dressings when managing infected chronic wounds. They appear more effective and are tolerated well by patients. However, their use should be accompanied by a comprehensive wound assessment.
Press Release: Altrazeal(TM) Clinical Evidence to be Presented at The American Professional Wound Care Association (APWCA) National Clinical Conference 2009
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ADDISON, Texas, April 1 / ULURU Inc. (NYSE Alternext: ULU) announced today that clinical evidence on the treatment of wounds using Altrazeal(TM) Transforming Powder Dressing, and data on the physical properties of Altrazeal(TM) Silver will be presented at the annual APWCA National Clinical Conference in Philadelphia, April 2-5, 2009. The work will be presented in podium presentations and with posters on display during the meeting.
Renaat Van den Hooff, President and CEO of ULURU Inc., commented: "Since the launch of Altrazeal(TM) in June 2008, we have accumulated extensive clinical experience across all wound types. The presentation of this data in a formal forum is a reflection of the execution of an important part of our 2009 business strategy."
Dr. Brock Liden, DPM of the Berger Health Care Center in Circleville, Iowa, will discuss at one podium presentation a talk titled "Treatment methods and experience with a novel aggregating powder dressing." In this presentation, Dr. Liden will detail his experiences and best clinical practice using Altrazeal(TM), application techniques, and what to expect when applying and treating wounds with the dressing.
In addition, clinical evidence using Altrazeal(TM) in treatment of diabetic foot ulcers, surgical wounds, and difficult to treat wounds such as those on sickle cell patients or patients afflicted with lymphangioma or pyoderma will be presented. A total of five posters detailing clinical evidence of Altrazeal(TM) will be displayed including one that shows the successful use of Altrazeal(TM) under contact casts in the treatment of diabetic foot ulcers. Commenting on the product, Dr. Greg Bohn, MD, FACS, Medical Director of the Trinity Center for Wound Care and Hyperbaric Medicine in Bettendorf, Iowa, and author of three of the posters stated, "Altrazeal(TM) is proving to be a very versatile dress
Case reports on the use of antimicrobial (silver impregnated) soft silicone foam dressing on infected diabetic foot ulcers.
Tong JW. Int Wound J. 2009 Aug;6(4):275-84.
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This article described four patients who had an episode of an infected foot ulcer, and subsequently treated with a novel antimicrobial soft silicone foam dressing together with standard off-loading and antibiotic therapy. Qualitative description of the ulcer-healing process was documented. All four ulcers showed positive wound contraction and reduction in size throughout the follow-up period ranging from 3 to 16 weeks. In addition, clinical signs of infection were absent at the end of the follow-up period. Moreover, surrounding skin maceration and trauma were absent in all wounds. Adequate moisture control was also achieved with the evidence of a healthy red granulating base, and a thin layer of clear light exudate in three out of the four cases. However, these reports had very little evidence to show the dressing's effectiveness in combating wound infection, but there might be some possible clinical efficacies of the dressing to control infection. Appropriate antibiotic therapy and off-loading are still essential components when treating diabetic foot infection.
Sustained-release silver foam dressings
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