A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology

NACompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

February 13, 2022

Study Completion Date

February 13, 2022

Conditions
Peristomal Skin Complication
Interventions
DEVICE

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.

Trial Locations (1)

2400

Bispebjerg Hospital, Copenhagen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY