A clinical investigation of a new gelling fibre dressing containing silver for the management of venous leg ulcers.

Abstract

Objective: To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, in venous leg ulcers (VLUs) after four weeks of treatment.

Method: This non-comparative, one-armed, open-labelled study included patients from two sites (clinics or community nursing caseloads) in the UK between February and May 2024. The primary endpoint was relative wound area reduction (WAR) after four weeks of treatment. Adverse events (AEs) were also assessed.

Results: In total, 50 patients with VLUs either infected or at risk of infection, and with medium-to-high levels of exudate, were included in the intention-to-treat (ITT) population. Of these, 45 patients completed the investigation on treatment and five patients discontinued the treatment. In the primary analysis, the estimated mean relative WAR after four weeks was 46.3% (95% confidence interval (CI): 36.5, 56.2%) in the full analysis set (n=49). In the sensitivity analysis based on the ITT population, it was 43.9% (95% CI: 33.1, 54.7%). In total, three AEs were found to be related to the investigational device; all were non-serious.

Conclusion: In this study, treatment of VLUs with the investigational device showed that the mean relative WAR after four weeks of treatment was 46.3%. This reduction in wound area is comparable to the performance of other silver-containing wound dressings. In addition, the results of this clinical investigation revealed no safety concerns. Thus, the study demonstrated that the investigational device is both a safe dressing and one that performs as intended to facilitate VLU healing.