NCT05824026

Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years – 65 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 partial thickness burn wound, which is infected or at risk of infection. Participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 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 product has a classification III, as it contains the active ingredient silver. 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 two weeks (+/- 2 days), consisting of a two-week test period and 4 study visits (V0/V1, V2 and V3). V3 will also terminate the 2-week study period. The primary endpoint is percentage of wounds healed within 14 days (≥ 95 % reepithelialisation) The clinical investigation will be conducted in a total of 50 eligible subjects with a partial thickness burn wound that are infected or at risk of infection.

Conditions

• Partial-thickness Burn

Interventions

Type	Name	Description
DEVICE	Gelling fiber wound dressing with silver	intervention involving a wound dressing with silver

Timeline

• Start date: 2023-10-27
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2023-04-21
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

5 sites across 1 country: United Kingdom