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

Recruiting now · Phase 4

Conditions studied: Surgical Site Infection, Wound Surgical, Colorectal Disorders

In brief

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.

Key facts

Study ID

NCT06309368

Run by

University of Nevada, Las Vegas

People needed

84

Starts

2024-03-14

Expected to finish

2029-12-01

Last updated by the study team

2025-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
• Signed consent

You may not qualify if…

• Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy

Where it is running

• University Medical Center — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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