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Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Dec 2024 to Dec 2028v4 Show 5 more changesShow less
    • Study completion date: Dec 2025 to Dec 2029
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (5)
    • Site contact updated
    • Study title shortened, about 1 word
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Mar 14, 2024
    • Site details revised
    v3
  3. Secondary endpoints: 4 to 5
    • Study description revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are: 1. Surgical site infection rates 2. Patient quality of life 3. Time to wound healing Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above.
Trial Details
NCT Number NCT06309368
Lead Sponsor University of Nevada, Las Vegas
Conditions
(from sponsor)		 Surgical Site Infection, Wound Surgical, Colorectal Disorders
Related terms Surgical Wound, Surgical Wound Infection
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov