ACTICOAT™ for the treatment of burns and chronic wounds
Research type
Research Study
Full title
A prospective, non-comparative, multicentre study to evaluate a silver coated antimicrobial barrier wound dressing (ACTICOAT™) in the treatment of burns and chronic wounds.
IRAS ID
211260
Contact name
Stewart Richmond
Contact email
Sponsor organisation
Smith and Nephew plc
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
The aim of the study is to evaluate subject reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a variety of wound types. It is widely used in routine clinical practice within the UK. ACTICOAT is CE marked and will be used within its intended indications for use. The proposed study is required for regulatory purposes for continuing Post Market Clinical Follow Up in accordance with MEDDEV 2.12-2.
Primary Objective
To evaluate change in health related quality of life, associated with treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single index utility scores from baseline to 3 weeks.The study will also seek to gather and report relevant safety and performance data and evaluate change, where applicable, for outcomes including: clinical signs and symptoms of infection; wound length / width / depth; wound healing measures; tissue staining; pain, adherence, and pain on application / removal; wear time; adverse events and device deficiencies.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0349
Date of REC Opinion
23 Aug 2016
REC opinion
Further Information Favourable Opinion