Comparing Suprasorb4XPHMB Pro and Suprasorb4XPHMB Dressings for Treating Infected Venous Leg Ulcers in Adults

What this Trial Is About

Researchers are evaluating two types of PHMB-impregnated biocellulose wound dressings, SuprasorbXPHMB Pro and SuprasorbXPHMB, to compare their performance and safety in treating patients with infected venous leg ulcers. This multicenter, open-label, randomized parallel group controlled study focuses on patients with slight to moderate wound exudation, aiming to improve treatment outcomes for this condition. Patients with high wound exudation may first undergo a 7-day run-in period receiving superabsorbent dressings and monitored compression therapy, including systemic antimicrobial drugs if needed. After this, eligible patients will be randomly assigned to receive either SuprasorbXPHMB Pro or SuprasorbXPHMB dressings. All patients will receive their assigned dressing for about 21 days, or until complete wound healing occurs, alongside continued compression therapy and systemic antimicrobial treatment as required. Participants will be assessed at baseline, interim, and end-of-treatment visits for wound characteristics, exudation levels, infection status, pain, quality of life, and product usability. Dressing changes may occur as needed during the study. The main outcome measured is the rate and severity of skin maceration after three weeks of treatment. The study lasts about three weeks, after which further treatment is managed outside the trial.

Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers