Leg ulcers and the Urgocell Non-Adhesive wound dressing

Abstract

The objectives of this clinical trial were to evaluate the efficacy and tolerance of the Urgocell Non-Adhesive (NA) dressing in the local management of venous or mixed leg ulcers. The study was a non-comparative, prospective, multicentre (15 centres) phase III, clinical trial. The studied population was composed of non-immunodepressed adults presenting a venous or mixed leg ulcer, uninfected, non-cancerous, present for less than 18 months. Patients were followed up for 6 weeks with a weekly visit, including a clinical examination, area tracings and photographs. Evaluation by nursing staff and patients was performed at each dressing changed. Forty-three patients were included, presenting a leg ulcer with a mean surface area of 10.7 cm2. The surface area was reduced by a mean of 38% after 6 weeks of treatment. Four local adverse events were deemed to be related to the tested treatment and acceptability was noted very good for patients and nursing staff. The Urgocell NA dressing, combined with compression therapy, promoted the healing of the chronic wounds under study. The good tolerance and acceptability of the tested dressing were greatly appreciated.