AQUACEL Ag+ Extra in burns (U373) Version 5
Research type
Research Study
Full title
A multi centre study to assess the safety and performance of AQUACEL Ag+ Extra in partial thickness burns (CW 0842-13-U373)
IRAS ID
144640
Contact name
Simon Booth
Contact email
Sponsor organisation
ConvaTec
Research summary
This is a study to evaluate the safety and performance of AQUACEL Ag+ Extra in the treatment of partial thickness (2nd degree) burns. The dressing has been CE marked for other wound types but not for burns. Approximately 20 subjects from sites within the United Kingdom will take part in this study. A study burn will be identified as per the protocol inclusion and exclusion criteria. All study burns will be dressed with AQUACEL Ag+ Extra for up to 21 days or until healing or withdrawal of the subject, whichever occurs first. The study burns will be assessed and redressed as clinically indicated. The study requires no additional procedures outside of usual clinical practice, but Investigator’s will be asked to photograph the burn dressed and undressed whenever the dressing is assessed or changed. All data will be collected on a paper Case Report Form.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0023
Date of REC Opinion
26 Feb 2014
REC opinion
Further Information Favourable Opinion