CP357 - Biatain Fiber Ag on burns
Research type
Research Study
Full title
Investigation of the clinical performance of Biatain Fiber Ag on burns
IRAS ID
327810
Contact name
Lewis Christopher Lewis
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
The overall purpose of this investigation is to obtain clinical data supporting effectiveness of the final product to obtain the CE-mark.
Subjects will use the investigational test product in a 2-week test period (+/- 2 days) and have a scheduled visit once per week, visit 2 (V2) and visit 3 (V3). V3 will also terminate the 2-week study period unless a situation occurs where a subject terminates earlier than expected.
The majority of endpoints captured in this study are well known in wound care and similar to what is already done when assessing a wound but also more test product specific endpoints like how easy it is to remove the test product in one piece are captured.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/LO/0557
Date of REC Opinion
25 Jul 2023
REC opinion
Further Information Favourable Opinion