DuoDERM Extra Thin Film Layer Wear Test (CW-0066-13-U370)
Research type
Research Study
Full title
A single centre, comparative, blinded wear test of two film layers on the DuoDERM® Extra Thin dressing
IRAS ID
139444
Contact name
Gwenneth Lawrence
Contact email
Sponsor organisation
ConvaTec Ltd
Research summary
This is a comparative wear test study (no treatment or clinical intervention) to evaluate the performance of the DuoDERM® Extra Thin dressing for a planned change to the outer film layer component of the dressing.\nThe study duration will be a maximum of 7 days; approximately 20 volunteers will be enrolled in the study. Each healthy volunteer will wear four dressings: they will wear both versions of the dressing simultaneously (2 dressings from each Type group, a total of 4 dressing per volunteer at any one time). Dressings will be placed one on each upper arm and two on the lower back. The investigator will apply the currently marketed dressing and the test dressing which is the same product but with the thinner outer film layer to each subject.\nThe dressings on each arm will be removed after 72 hours and assessments of ease of removal, comfort during removal and skin condition assessed. Fifteen minutes after removal, a new dressing of the appropriate categories will then be applied to the arms of each healthy volunteer. Subjects will wear the dressings continuously from day 1 to day 7. At the end of the 7 days, the subjects will return to the investigator for assessment of the performance of the dressing and skin condition using the skin irritation chart and photographs will be taken.\nSubjects will also complete a diary card over the 7 day period to capture events of dressing detachment.\nAdverse events will be reported in the case report form. \n
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0406
Date of REC Opinion
21 Oct 2013
REC opinion
Favourable Opinion