Novel Post-Surgical Incision Management to Prevent Ostomy Complications

The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are: Primary Hypothesis 1: Peristomal Skin Complications will decrease Primary Hypothesis 2: Dressing Leak Rates will decrease Participants will: * Receive either the Limpet device or standard of care adhesive ostomy pouch dressing * Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

NCT Number	NCT06524401
Lead Sponsor	HealthPartners Institute
Conditions	Ostomy, Enterocutaneous Fistula
Enrollment	92 participants
Start Date	2024-11-18
Primary Completion	2029-01 (estimated)
Study Completion	2029-03 (estimated)
Updated on ClinicalTrials.gov	2025-09-25