Comparing two methods for closing ostomy wounds
To Close or Not to Close: Surgical Site Infection Rates in Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Conventional Ostomy Closure by Secondary Intention
PHASE4 · University of Nevada, Las Vegas · NCT06309368
This study is testing two different ways to close ostomy wounds to see which method helps patients heal better and feel good about their recovery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nevada, Las Vegas (other) |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT06309368 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require ostomy reversal.
Not a fit: Patients under 18 years old or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced infection rates for patients undergoing ostomy closure.
How similar studies have performed: Previous studies have indicated that improved closure techniques can reduce infection rates, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Las Vegas, Nevada
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Site Infection, Wound Surgical, Colorectal Disorders, Ostomy, Primary Closure, Secondary Closure