NCT03277131

DURAFIBER Ag Post-Market Clinical Follow-Up

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Wounds and Injuries
• Venous Leg Ulcer
• Infection

Interventions

Type	Name	Description
DEVICE	DURAFIBER Ag	DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing

Timeline

• Start date: 2017-12-12
• Primary completion: 2019-06-19
• Completion: 2019-06-19
• First posted: 2017-09-08
• Last updated: 2022-03-02

Locations

7 sites across 1 country: United Kingdom