At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ATTRACT-I: A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
In Brief
A clinical study evaluating ATTRACT-I for Peristomal Skin Complication. Completed, enrolled 89 participants across 1 site.
Detailed Summary
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.
Study Details
Timeline
Interventions
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.