Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Launched by HEALTHPARTNERS INSTITUTE · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new device called the Limpet, which is designed to manage surgical incisions for patients with ostomies or enterocutaneous fistulas. The main goal is to see if the Limpet can help reduce skin problems around the stoma (the opening created for waste to leave the body) and decrease the number of times the dressing leaks compared to standard ostomy pouches. Participants in this trial will receive either the Limpet or a regular adhesive pouch and will visit the study site every week for 30 days to have their dressings changed, undergo wound checks, and complete surveys about their quality of life.

To be eligible for this trial, participants must be over 18 years old, undergoing ileostomy surgery, or have a fistula with a significant amount of output. Their stoma should not be larger than 1.5 inches, and the skin around the stoma must be intact. Participants should also be able to understand the study instructions in English, Spanish, Hmong, or Somali and agree to follow the study requirements. It's important to note that individuals who smoke, are pregnant, or have certain health conditions may not qualify. Overall, the trial aims to find a better way to manage ostomy care and improve patients' experiences after surgery.

Gender

ALL

Eligibility criteria

• 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 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.