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Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Sponsor: HealthPartners Institute
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2024-11-18
Completion Date
2029-03
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
Limpet
Limpet participants will have their device placed by a clinician. Upon discharge, a portable vacuum pump will be issued to provide negative pressure (e.g., 3M Prevena or Snap; ConvaTec Avelle; or Pensar MicroDoc). These systems are compact, fit in a pocket, are simple to operate, and commonly used in the outpatient setting to provide multiple weeks of therapy. Participants will be furnished with materials to address potential dressing problems while at home: extra waste pouches, adhesive drape strips for sealing air leaks, and standard of care adhesive ostomy pouches and accessories as a backup plan in the event of a Limpet failure.
Control
Control participants will receive standard of care adhesive ostomy pouch dressings. Participants will be furnished with materials to address potential dressing problems while at home: adhesive ostomy pouches and accessories for pouch replacement. The Control group will change their pouches at home 2 to 5 times per week or more frequently if needed, as per the current standard of care.
Locations (1)
Regions Hospital
Saint Paul, Minnesota, United States