Clinical Trial

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

Recruiting Phase 4
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-03-06; most recent amendment 2025-05-27.
Status change: Not Yet Recruiting → Recruiting 2024-03-21
Trial Details
NCT Number NCT06309368
Lead Sponsor University of Nevada, Las Vegas
Conditions Surgical Site Infection, Wound Surgical, Colorectal Disorders
Enrollment 84 participants
Start Date 2024-03-14
Primary Completion 2028-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-02