NCT05873257

Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers

Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.

Detailed description

: The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU. The total study duration for the subject will be approximately four weeks, consisting of a four-week test period and 6 study visits (V0/V1, V2, V3, V4 and V5). V5 will also terminate the 4-week study period. The primary endpoint is Mean area wound reduction. The endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Biatain Fiber Ag applied to participants	Intervention involving a wound gelling fiber dressing with silver

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2023-05-24
• Last updated: 2025-06-03
• Results posted: 2025-06-03

Locations

1 site across 1 country: United Kingdom