Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Recruiting N/A Interventional Study
Ostomy Enterocutaneous Fistula
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
92 (estimated)
Sponsor
HealthPartners Institute · Other
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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: Prima…
Trial Locations
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Eligibility Criteria
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 Investiga…
Contacts

Allison Kehren

651-254-5342

Allison.J.Kehren@HealthPartners.Com

CONTACT