User Assessment of the NovaLife One-Piece Flat Skin Barrier
Research type
Research Study
Full title
User Assessment of the NovaLife One-Piece Flat Skin Barrier.
IRAS ID
132088
Contact name
Heather Dennis
Contact email
Sponsor organisation
Dansac Limited
Research summary
The Dansac NovaLife Flat skin barriers to be used in this study are made with a new barrier material called GX+. This material is designed to have increased resistance to erosion to improve wear time. The purpose of this study is to assess the user perception of the flat 1-piece barrier as compared to their normal barrier. Subjects who have an ileostomy will be asked to record the wear time and their assessment of the relevant characteristics for each skin barrier by completing a questionnaire for each barrier. Each subject will be provided with 1 box of 5 skin barriers/pouches. Subjects wear the study skin barriers according to their normal habits for 5 consecutive wears. Study participation will last approximately 10 days.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1438
Date of REC Opinion
14 Oct 2013
REC opinion
Favourable Opinion