title: Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers.
abstract: 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.
authors.affiliation: Wound Healing Research Unit (WHRU), Cardiff University School of Medicine, Cardiff, UK.
authors.forename: Keith G
authors.initials: KG
authors.lastname: Harding
authors.affiliation: Cross Medica 2, Warsaw, Poland.|Department of Rehabilitation, Jozef Pilsudski University of Physical Education, Warsaw, Poland.|Clinical Department of General and Colorectal Surgery, Bielanski Hospital, Warsaw, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Szczepkowski
authors.affiliation: Mikomed, Łódź, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Mikosiński
authors.affiliation: Vein Clinic "Medservice", Zabrze, Poland.
authors.forename: Krystyna
authors.initials: K
authors.lastname: Twardowska-Saucha
authors.affiliation: Vascular Surgery Department, Arrowe Park Hospital, Wirral, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Blair
authors.affiliation: Wound Healing Research Unit (WHRU), Cardiff University School of Medicine, Cardiff, UK.
authors.forename: Nicola M
authors.initials: NM
authors.lastname: Ivins
authors.affiliation: Vein Clinic "Medservice", Zabrze, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Saucha
authors.affiliation: Clinical Affairs, ConvaTec Ltd., Flintshire, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Cains
authors.affiliation: Clinical Affairs, ConvaTec Ltd., Flintshire, UK.
authors.forename: Kim
authors.initials: K
authors.lastname: Peters
authors.affiliation: Research and Development, ConvaTec Ltd., Flintshire, UK.
authors.forename: David
authors.initials: D
authors.lastname: Parsons
authors.affiliation: Research and Development, ConvaTec Ltd., Flintshire, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Bowler
mesh_terms: D000900:Anti-Bacterial Agents; D001458:Bandages; D006801:Humans; D014647:Varicose Ulcer; D014945:Wound Healing
chemical_list: D000900:Anti-Bacterial Agents
keywords: Antimicrobial dressing; Biofilm; Venous leg ulcer; Wound healing