Open AccessSafety and performance evaluation of a next‐generation antimicrobial dressing in patients with chronic venous leg ulcers
Author(s) -
Harding Keith G,
Szczepkowski Marek,
Mikosiński Jacek,
TwardowskaSaucha Krystyna,
Blair Stephen,
Ivins Nicola M,
Saucha Wojciech,
Cains Jane,
Peters Kim,
Parsons David,
Bowler Philip
Publication year - 2016
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/iwj.12450
Subject(s) - medicine , adverse effect , venous leg ulcer , systemic antibiotics , surgery , wound dressing , antimicrobial , safety profile , antibiotics , chemistry , materials science , organic chemistry , microbiology and biotechnology , composite material , biology
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.