RecruitingPhase 4

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

United States84 participantsStarted 2024-03-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled * Signed consent Exclusion Criteria: * Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy

What they're measuring

Surgical Site Infection Rates

Timeframe: Evaluate surgical site for any signs of infection up to 30 days post-operatively.

Trial details

NCT IDNCT06309368

SponsorUniversity of Nevada, Las Vegas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Abigail W Cheng, MD

9166954159 abigail.cheng@unlv.edu

View on ClinicalTrials.gov More Surgical Site Infection trials