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Novel Post-Surgical Incision Management to Prevent Ostomy Complications

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Aug 2025 to Jan 2029 Completion date: Sep 2025 to Mar 2029 · Site contact updatedv5 Show 2 more changesShow less
    • Completion date: Sep 2025 to Mar 2029
    • Site contact updated
  2. Eligibility criteria shortened, about 21 wordsv4 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 11, 2024 to Nov 18, 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Nov 11, 2024 to Nov 18, 2024
    • Site details revised
  4. Start date: Aug 2024 to Nov 11, 2024 Eligibility criteria shortened, about 2 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06524401
Lead Sponsor HealthPartners Institute
Conditions Ostomy, Enterocutaneous Fistula
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov