Comparing two methods for closing ostomy wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two closure techniques for patients with ostomies ready for closure: primary closure using a 0.1% betaine and 0.1% polyhexanide wound irrigation solution, and the Pursestring closure method, which allows the wound to heal from the inside out. The study will evaluate surgical site infection rates, patient quality of life, and time to wound healing between the two methods. Participants will be recruited from the UNLV Colorectal Clinic, and surgeries will be performed at University Medical Center. The trial is designed as a non-inferiority study to determine if the primary closure method is at least as effective as the Pursestring method.

Why it matters

Who can join: the full rules

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

Where it's running

• University Medical Center
  Las Vegas, Nevada, United States Recruiting

Study contacts

• Principal investigator: Ovunc Bardakcioglu, MD — Kirk Kerkorian School of Medicine at UNLV
• Study coordinator: Abigail W Cheng, MD
• Email: abigail.cheng@unlv.edu
• Phone: 9166954159

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.