New device for managing post-surgical ostomy complications

Novel Post-Surgical Incision Management to Prevent Ostomy Complications

This study is testing a new device called the Limpet to see if it can help people with ostomies and fistulas have fewer skin problems and leaks compared to regular ostomy pouches.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: HealthPartners Institute (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Saint Paul, Minnesota)
• Trial ID: NCT06524401 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Limpet device compared to standard ostomy pouches in reducing complications for patients with ostomies and enterocutaneous fistulas. Participants will receive either the Limpet or standard care dressing and will return weekly for 30 days for device replacement, wound imaging, blood tests, and quality of life assessments. The study aims to demonstrate a significant reduction in peristomal skin complications and dressing leak rates. It focuses on patients undergoing ileostomy surgery or those with high-output enterocutaneous fistulas.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 undergoing ileostomy surgery or with high-output enterocutaneous fistulas.

Not a fit: Patients with a life expectancy of less than 30 days or those with specific types of fistulas may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce complications and improve the quality of life for patients with ostomies and fistulas.

How similar studies have performed: Other studies have shown promise in similar approaches, but this specific device's effectiveness is being evaluated for the first time.

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 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 participate.

Exclusion Criteria:

* 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)
* Participant is scheduling/planning concurrent chemotherapy or other 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 (verbal report).
* Participant is unable or unwilling to provide informed consent.
* Participant is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
* Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.

Where this trial is running

Saint Paul, Minnesota

• Regions Hospital — Saint Paul, Minnesota, United States (RECRUITING)

Study contacts

• Study coordinator: Allison Kehren

Conditions: Ostomy, Enterocutaneous Fistula, Stoma, Ileostomy