DURAFIBER Ag PMCF Study
Research type
Research Study
Full title
A Prospective, Open, Non-Comparative Multicentre Study to Evaluate a Fibrous Silver Dressing (DURAFIBER™ Ag) in the Treatment of Moderate to Highly Exuding Venous Leg Ulcers
IRAS ID
228372
Contact name
Judith Horner
Contact email
Sponsor organisation
Smith & Nephew
Duration of Study in the UK
0 years, 11 months, 10 days
Research summary
The aim of the study is to evaluate the performance of DURAFIBER Ag with a reduced silver content and to assess how many bacteria are present in infected wounds over an 8 week period.
DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing for use on a variety of exuding wounds and is widely used in routine clinical practice within the UK.
Since DURAFIBER Ag was first launched it has been subject to a change in recipe which has included a reduction in the silver content of this dressing. This study will focus on the use of the newly-revised DURAFIBER Ag in the treatment of infected and moderate to highly exuding venous leg ulcers.
ACTICOAT is CE marked and will be used within its intended indications for use. The proposed study is required for regulatory purposes for continuing Post Market Clinical Follow Up in accordance with MEDDEV 2.12-2.
The primary outcome will be the quantitative reduction in bacterial load, based on a wound biopsy, from baseline to week 8. Secondary objectives will include the quantitative reduction in bacterial load, based on biopsy, from initial assessment to week 4, and the semi-quantitative reduction in bacterial load, based on swab analysis, from baseline to weeks 4 and 8. Additionally dressing performance measures will be assessed as well as all adverse events and device deficiencies.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
17/YH/0269
Date of REC Opinion
22 Aug 2017
REC opinion
Favourable Opinion