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Clinical Research
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Safety and efficacy in long-term use of a sustained silver-releasing foam dressing: a randomized, controlled trial on venous leg ulcers Ivins N, Harding KG, Price P, Wound Healing Research Unit, Cardiff Medicentre, Cardiff, UK; Jurgensen B, Lohmann M, Copenhagen Wound Healing Centre; Gottrup F, Andersen KE, Odense University Hospital; Bech-Thomsen N, Hudklinikken, Naestved, Denmark; Scanl Introduction: It has been shown that a sustained silver-releasing foam dressing is safe and effective for the treatment of leg and diabetic foot ulcers with reductions in wound areas of 45%Ð56% within 4 weeks. This study investigated the safety and performance of this silver foam on leg ulcers with delayed healing 5Ð8 weeks after initiation of treatment versus a non-silver foam dressing. Methods: 45 patients with a chronic venous or mixed venous/arterial leg ulcer were subjected to 4 weeks treatment with the silver foam. For the present study they were re-randomized to receive treatment with either the silver foam (25) or the non-silver foam (20) for 4 additional weeks. Ulcer area and healing were assessed weekly. Odor, leakage and maceration were evaluated at dressing changes. Results: Reduction in ulcer area was significantly greater in the silver foam group versus the non-silver group (P<0.05). Mean reduction in ulcer area over 4 weeks was 26.2% in the silver foam group and 9.5% in the comparator group. Two ulcers healed in the silver foam group versus one ulcer in the comparator group. Higher incidences of leakage and odor were reported in the non-silver group. Incidence of maceration was low in both groups. No device-related adverse events were recorded in the silver foam group while 2 skin reactions were observed in the non-silver foam group. Reversible silver staining was observed in 2 patients at some dressing changes in the silver foam group.. .Conclusions: Silver foam can be used for at least 8 weeks with no safety concerns. There were occasional minor side effects in both treatment groups, but no device-related adverse events were observed in the silver foam group. The reduction in ulcer area was greater with the silver foam compared to the non-silver foam. The dressings performed similarly for all other rated parameters +Contreet¨ Foam, Coloplast, Marietta, GA º.*Allevyn¨ Hydrocellular, Smith & Nephew, Largo, FL Karlsmark T, et al. JWC . 2003;12(9) Jurgensen B, et al. IWJ. 2005;2(1). Rayman G, et al. BJN. 2005;14(2). Russell L. Wounds UK. 2005;1(1). |
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