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.
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