Improvement of periulcer skin condition in venous leg ulcer patients: prospective, randomized, controlled, single-blinded clinical trial comparing a biosynthetic cellulose dressing with a foam dressing

Abstract

Objectives: The aim of this study was to investigate the influence of a biosynthetic cellulose wound dressing (BWD) to stimulate wound healing in patients with a venous leg ulcer on periulcer skin condition when compared with standard care using a foam dressing.

Methods: Each patient with a venous ulcer received compression therapy with a short stretch bandage system and either a BWD + foam (study group [SG]) or foam (control group [CG]). Periulcer skin condition was compared with the untreated lower leg skin and the forearm skin, using noninvasive parameters, comparing day 0 versus day 28 results. Ulcers were further evaluated for healing rate. The study period was 28 days, and the follow-up period was 12 weeks. Fifty patients were recruited to the study, of which N = 46 (SG, n = 26; CG, n = 20) completed the 28-day study period and were included in the analysis.

Results: The BWD showed a more improved periulcer skin condition versus the CG. Transepidermal water loss was significantly less in the SG (P = .003), as well as the results shown with the chromatometer (P =. 05). Ulcer healing rate was also statistically significant in favor of the SG (P = .0001).

Conclusion: Treatment for the BWD + foam group was shown to be safe and significantly improved periwound skin condition, leading to more expeditious wound healing than treatment with foam alone.