Novel Post-Surgical Incision Management to Prevent Ostomy Complications
HealthPartners Institute
92 participants
Nov 18, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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.
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Interventions
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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06524401