Novel Post-Surgical Incision Management to Prevent Ostomy Complications
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.
Description
The Limpet is a single-use device intended for effluent management and promotion of healing of intact and injured skin surrounding enterocutaneous fistulae and ostomies. Our study focuses on small bowel openings, encompassing two important cohorts: 1) ileostomy and 2) enterocutaneous fistulas (ECFs). Our study's success criterion is primarily based on the pooled results from both cohorts. Primary Hypothesis 1: Peristomal Skin Complications (PSCs): We hypothesize that the Limpet will demonstrate a significant improvement in PSCs compared to standard of care adhesive ostomy pouches. Specifical…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is greater than 18 years of age, inclusive * Participant is undergoing ileostomy surgery or, * has an enterocutaneous fistula with output over 500cc in 24 hours * Participants stoma will have a maximum diameter of 1.5 inches based on measurements from the Investigator or Sponsor. * Area around the stoma must have no injury through the dermis (i.e., intact skin) * Participant is willing and able to comply with all protocol-specified requirements * Participant is capable of reading and understanding English and will provide written informed consent to participa…
Interventions
- DeviceLimpet
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.
- DeviceControl
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.
Location
- Regions HospitalSaint Paul, Minnesota