A prospective, multi-centre, randomised, open label, parallel, comparative study to evaluate effects of AQUACEL® Ag and Urgotul® Silver dressing on healing of chronic venous leg ulcers

This study compared wound healing efficacy of two silver dressings, AQUACEL (R) Ag and Urgotul (R) Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL (R) Ag to Urgotul (R) Silver. Patients (281) were randomised into two groups. The AQUACEL (R) Ag group had 145 patients treated with AQUACEL (R) Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul (R) Silver group had 136 patients treated with Urgotul (R) Silver for 4 weeks followed by Urgotul (R) for another 4 weeks. In both groups, ulcer size and depth, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL (R) Ag group had a relative wound size reduction (49.65% +/- 52.53%) compared with the Urgotul (R) Silver group (42.81% +/- 60.0%). The non inferiority of the AQUACEL (R) Ag group to the Urgotul (R) Silver group was established based on the difference between them (6.84% +/- 56.3%, 95% confidence interval -6.56 to 20.2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL (R) Ag group had statistically higher percentage of subjects with better wound progression (66.9% versus 51.9%, P = 0.0108). In general, both dressings were effective at promoting healing of venous ulcers.