Novel Post-Surgical Incision Management to Prevent Ostomy Complications

NCT06524401 | Recruiting DMC

• 1 other identifier: A22-066
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ostomy; Enterocutaneous Fistula

Keywords

Stoma; Ileostomy

Outcome Measures

Primary Outcomes (2)

• Peristomal Skin Complications (PSCs)

  We hypothesize that the Limpet will demonstrate a significant improvement in PSCs compared to standard of care adhesive ostomy pouches. Specifically, we anticipate a raw difference of 35% in PSCs for the pooled cohorts, with a complication rate of 50% in the control group and 15% in the Limpet group.

  30 days

• Dressing Leak Rates

  We hypothesize that the Limpet will demonstrate a significant improvement in dressing leak rates compared to standard of care adhesive ostomy pouches. Specifically, we anticipate a raw difference of 15% in leak rates for the pooled cohorts, with a leak rate of 30% in the control group and 15% in the Limpet group.

  30 Days

Secondary Outcomes (1)

• Total Complications (PSCs and Stomal Complications)

  30 Days

Study Arms (2)

Limpet

EXPERIMENTAL

Participants in this arm will utilize the subject device as intended to be used.

Device: Limpet

Control

ACTIVE COMPARATOR

Standard treatment with standard of care adhesive ostomy pouches.

Device: Control

Interventions

Limpet DEVICE

Limpet participants will have their device placed by a clinician. Upon discharge, a portable vacuum pump will be issued to provide negative pressure (e.g., 3M Prevena or Snap; ConvaTec Avelle; or Pensar MicroDoc). These systems are compact, fit in a pocket, are simple to operate, and commonly used in the outpatient setting to provide multiple weeks of therapy. Participants will be furnished with materials to address potential dressing problems while at home: extra waste pouches, adhesive drape strips for sealing air leaks, and standard of care adhesive ostomy pouches and accessories as a backup plan in the event of a Limpet failure.

Limpet

Control DEVICE

Control participants will receive standard of care adhesive ostomy pouch dressings. Participants will be furnished with materials to address potential dressing problems while at home: adhesive ostomy pouches and accessories for pouch replacement. The Control group will change their pouches at home 2 to 5 times per week or more frequently if needed, as per the current standard of care.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

MeSH Terms

Conditions

Intestinal Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Allison Kehren

CONTACT

651-254-5342; Allison.J.Kehren@HealthPartners.Com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)