DURAFIBER Ag Post-Market Clinical Follow-Up

Infection Clinical Trial

Official 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

Status Completed

Clinical Trial Summary

The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period.

Clinical Trial Description

The aim of the study is to evaluate the performance of DURAFIBER Ag 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.

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.

In total 20 evaluable participants with an infected venous leg ulcer will be recruited into the trial. All participants will have their wound dressed using DURAFIBER Ag and will be followed-up for 8 weeks. ;

Related Conditions & MeSH terms

• Infection
• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Wounds and Injuries

• NCT number: NCT03277131
• Study type: Interventional
• Source: Smith & Nephew, Inc.
• Status: Completed
• Phase: N/A
• Start date: December 12, 2017
• Completion date: June 19, 2019