ALLEVYN Gentle Border PMCF Study
Research type
Research Study
Full title
A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
IRAS ID
269675
Contact name
Jeanette Milne
Contact email
Sponsor organisation
Smith & Nephew
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Application being processed, NIHR CRN
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
ALLEVYN Gentle Border is currently available on the market and provides an optimal moist wound healing environment to promote the healing of moderately and highly exuding wounds. It is widely used in routine clinical practice within the UK.
Since the launch of the product there has been a change in manufacture of the silicone wound contact layer. The aim of the study is to evaluate the performance of ALLEVYN Gentle Border with a new wound contact layer in the treatment of acute or chronic wounds. This study is designed to fulfill the requirements of an ALLEVYN Gentle Border Post Market Clinical Follow up.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0318
Date of REC Opinion
30 Oct 2019
REC opinion
Further Information Favourable Opinion