Actively Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Led by HealthPartners Institute · Updated on 2025-09-25
92
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Participant's stoma has 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 (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 participate.
You will not qualify if you...
- Unable or unwilling to attend the follow-up appointments
- Participant has a life expectancy less than 30 days
- Participant has a stature too small for use of the Limpet device according to the Investigator or Sponsor
- Participant has an enteroatmospheric fistula (enteric fistula to an open wound)
- Participant is scheduling or planning concurrent chemotherapy or radiation treatment during the study follow-up period
- Participant has a history of sensitivity or allergy to hydrocolloids or other materials in the Limpet device
- Participant is pregnant or planning to become pregnant
- Participant is unable or unwilling to provide informed consent
- Participant is currently participating in another investigational drug or device study that interferes with this study's endpoints
- Participant has any other disease or medical condition that could endanger them, interfere with evaluation of the device's safety or efficacy, or affect study compliance, in the opinion of the Investigator or Sponsor.
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Trial Site Locations
Total: 1 location
1
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
Research Team
A
Allison Kehren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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