About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Unable/unwilling to attend the follow-up appointments
Participant has a life expectancy < 30 days.
Participant has a stature too small for use of the Limpet in the opinion of the Investigator or Sponsor.
Participant has an enteroatmospheric fistula (enteric fistula to an open wound)
Trial design
Treatments tested in this trial
- Limpet
- Control