Objective: To evaluate the efficacy and tolerability of an innovative absorbent wound dressing (UrgoClean; Laboratoires Urgo) in the local management of venous leg ulcers and pressure ulcers, during the sloughy stage of the healing process.
Method: A pilot, prospective, non-controlled open-label clinical trial held in 21 investigating centres. Adult patients, presenting with either a venous leg ulcer (VLU) or a category III/IV pressure ulcer (PU) with more than 50% of the surface area covered with sloughy tissue, a duration of less than 24 months, and no clinical signs of infection were included in the study. Patients were followed over a 6-week period with weekly visits, which included a physical examination, wound-area tracings and photographs by the investigating physician. Evaluations by the nursing staff and by the patients were made at each dressing stage.
Results: Fifty patients with either a VLU (n=35) or a PU (n=15) were recruited. At baseline, mean wound surface area was 11.9 ± 11.3 cm(2) and 12.5 ± 10.7 cm(2), with a mean duration of 8.3 ± 6.4 months and 2.9 ± 3.0 months in the VLU and PU groups, respectively. Wounds in both groups were covered with more than 70% sloughy tissue, and the peri-lesional skin was considered to be healthy in 19 patients. By 6 weeks, mean wound surface area reduction in the VLU and PU groups was 23.7% and 29.2%, respectively, with full healing in 6 patients. All treated wounds were considered to be debrided by week 3 (<40% slough for all wounds) and the median relative decrease of the sloughy tissue, at week 6, in the VLU and PU groups was 75% and 89%, respectively. Dressing acceptability was documented as being very good for both patients and nursing staff, particularly conformability and ease of use, with no residue left on the wound bed at dressing removal and the dressing also remained in one piece. Seven local adverse events were deemed to be potentially related to the trial dressing.
Conclusion: The results suggest that the dressing promoted the healing process of chronic wounds, showing itself to be a credible therapeutic alternative for the sloughy stage of the wound-healing process. It also demonstrated good tolerance and acceptability.