Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers.

The objective of this study was to investigate the safety and performance of AQUACEL™ Ag+ dressing, a wound dressing containing a combination of anti-biofilm and antimicrobial agents, in the management of chronic wounds. Patients (n = 42) with venous leg ulcers exhibiting signs of clinical infection were treated for 4 weeks with AQUACEL™ Ag+ dressing, followed by management with AQUACEL™ wound dressings for 4 weeks. Wound progression, wound size, ulcer pain and clinical evolution of the wound were assessed for up to 8 weeks. Adverse events were recorded throughout the study. AQUACEL™ Ag+ dressing had an acceptable safety profile, with only one patient discontinuing from the study, because of a non-treatment-related adverse event. After 8 weeks, substantial wound improvements were observed: 5 patients (11·9%) had healed ulcers and 32 patients (76·2%) showed improvement in ulcer condition. The mean ulcer size had reduced by 54·5%. Patients reported less pain as the study progressed. Notable improvements were observed in patients with ulcers that were considered to require treatment with systemic antibiotics or topical antimicrobials at baseline (n = 10), with a mean 70·2% reduction in wound area. These data indicate that AQUACEL™ Ag+ dressing has an acceptable safety profile in the management of venous leg ulcers that may be impeded by biofilm.