Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT06524401
Status
Recruiting
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Conditions

  • Enterocutaneous Fistula
  • Ostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 18, 2024
Status verified
Sep 2025
Primary completion
Jan 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Limpet
    Participants in this arm will utilize the subject device as intended to be used.
  • Active Comparator: Control
    Standard treatment with standard of care adhesive ostomy pouches.

Primary Outcome Measure

Peristomal Skin Complications (PSCs) [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Regions HospitalSaint PaulMinnesota55101
Allison Kehren
[email protected]
651-254-5342

Find similar trials in Saint Paul, MN

By research site
Regions Hospital· Saint Paul, MN

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