89
Participants
Start Date
September 1, 2021
Primary Completion Date
February 13, 2022
Study Completion Date
February 13, 2022
ATTRACT-I
The aim of this investigation is to evaluate the performance and safety of an ostomy baseplate with a novel skin protection technology and its ability to reduce peristomal skin complications compared to SenSura® Mio. The subject will be randomized to either test product or comparator at enrollment. The subject will wear the test product for approximately 35 days and then cross-over to the comparator (or vice-versa) for approximately 35 days. At each baseplate change, the subject will answer questions about their skin, and take pictures of their stoma and used baseplate. They will also answer quality of life questionnaires at each study visit.
Bispebjerg Hospital, Copenhagen
Lead Sponsor
Coloplast A/S
INDUSTRY