Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHealthPartners Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Limpet
DeviceLimpet 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
DeviceControl 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.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: LimpetExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days2
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.
Time frame
30 DaysSecondary outcomes
1
Total Complications (PSCs and Stomal Complications)
We hypothesize that the Limpet will exhibit a raw difference of 35% in total complications (comprising PSCs and stomal complications like mucocutaneous separation and stoma retraction) for the ileostomy cohort. Stoma complication rates vary widely in the literature, and we plan to conduct sub analyses to evaluate the Limpet's effect on stoma complications independent of PSCs.
Time frame
30 DaysSponsors and contacts
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Source ClinicalTrials.gov