| 45 |
Clinical Research
|
Evaluation of a new contact layer impregnated with silver salts* in the management of critically colonized venous leg ulcers: results of a clinical trial First Author: Jean-Marc BRESSIEUX Authors: JM. Bressieux, M. Sigal, I. Lazareth, S. Bohbot Experts are still debating the therapeutic strategy to adopt in front of wounds which are not clinically infected but presenting signs of "critical colonization". So, a clinical trial was carried out to evaluate the utility of a silver impregnated dressing in such chronic wounds. A prospective, multicentre, randomised, phase III clinical trial conducted in parallel groups was carried out with an 8 week follow-up (weekly basis, including a clinical score and a planimetric area). Among the selection criteria, the existence of 3 of the following 5 synoptoms was needed : perilesional inflammation, pain between two dressing changes, malodorous wound, abundant exudate and oedema. The silver group received a sequential treatment: 4 weeks with the silver contact layer followed by 4 weeks with a neutral interface**. The control group received 8 weeks continuous treatment with the same neutral dressing. One hundred two patients were enrolled in the trial. Baseline characteristics (patients/lesions) were similar in the two groups. The surface area reduction and the reduction of the Clinical Score were significantly greater at the end of the 8-week treatment in the silver group. This trial demonstrates the performance of a dressing impregnated with silver salts in the management of chronic wounds presenting a high risk of secondary infection. *Restore Contact Layer, Silver, Hollister Wound Care, Libertyville, IL **Restore Contact Layer with Triact Technology, Hollister Wound Care, Libertyville, IL Supported in part by Hollister Wound Care, L.L.C. |
|