Novel Post-Surgical Incision Management to Prevent Ostomy Complications
United States92 participantsStarted 2024-11-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 condi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.