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® Ag and Urgotul® Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL® Ag to Urgotul® Silver. Patients (281) were randomised into two groups. The AQUACEL® Ag group had 145 patients treated with AQUACEL® Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul® Silver group had 136 patients treated with Urgotul® Silver for 4 weeks followed by Urgotul® 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® Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul® Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL® Ag group to the Urgotul® 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® 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.