Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06524401

Novel Post-Surgical Incision Management to Prevent Ostomy Complications Using the Limpet Device Compared to Standard Ostomy Pouches

Led by HealthPartners Institute · Updated on 2025-09-25

92

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Limpet device compared to standard ostomy pouches in reducing complications for people with ostomies and enterocutaneous fistulas. The study focuses on small bowel openings, including ileostomy and fistula patients. It aims to see whether the Limpet can lower skin complications around the stoma and reduce dressing leaks over 30 days. The study also looks at overall complications and subgroup differences based on stoma type and other factors. Participants will be randomly assigned to one of two groups: one using the Limpet device with a portable vacuum pump to provide negative pressure, and one using standard adhesive ostomy pouches. The Limpet group will be given extra materials to manage dressing issues at home, while the control group will follow usual care with standard pouches and necessary supplies. Device replacement and assessments will occur weekly during the 30-day treatment period. Participants will attend clinic visits roughly every 7 days for device changes, wound imaging, blood tests, and quality of life surveys. The study includes a screening visit, baseline visit, and four weekly follow-ups, ending with a final appointment about 30 days after surgery. Researchers will measure skin complications and dressing leak rates as primary outcomes, along with total complications, to assess the device's impact. Safety and adherence will be monitored throughout the study.

CONDITIONS

Brief Title

Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is 18 years of age or older, inclusive
  • Undergoing ileostomy surgery or has an enterocutaneous fistula with output over 500cc in 24 hours
  • Stoma has a maximum diameter of 1.5 inches based on Investigator or Sponsor measurements
  • Skin around the stoma is intact with no injury through the dermis
  • Willing and able to comply with all study requirements
  • Able to read and understand English and provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable or unwilling to attend follow-up appointments
  • Life expectancy less than 30 days
  • Stature too small for use of the Limpet device as determined by Investigator or Sponsor
  • Presence of enteroatmospheric fistula (enteric fistula to an open wound)
  • Planning chemotherapy or radiation treatment during the study follow-up period
  • History of sensitivity or allergy to hydrocolloids or materials in the Limpet device
  • Pregnant or planning to become pregnant
  • Unable or unwilling to provide informed consent
  • Currently participating in another investigational drug or device study that interferes with this study
  • Any other medical condition that could endanger the participant or interfere with study evaluations as judged by Investigator or Sponsor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - Approximately 4 to 5 weeks before baseline

Participants are screened for eligibility to participate in the trial.

1 visit (in-person clinic)

Baseline

Duration - Day 1

Participants attend a baseline clinic visit where initial data is collected before starting the assigned treatment.

1 visit (in-person clinic)

Treatment

Duration - 30 days

Participants receive either the Limpet device with a portable vacuum pump or standard care adhesive ostomy pouches. They manage their device or pouch at home with materials provided and return for weekly clinic visits for device or dressing replacement and monitoring.

Weekly clinic visits for up to 4 weeks

Trial Site Locations

Total: 1 location

1

Regions Hospital

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

Loading map...

Research Team

A

Allison Kehren

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here