NCT06309368 Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
| NCT ID | NCT06309368 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Nevada, Las Vegas |
| Condition | Surgical Site Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 84 participants in total. It began in 2024-03-14 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Ovunc Bardakcioglu, MD
PRINCIPAL INVESTIGATOR
Kirk Kerkorian School of Medicine at UNLV
Frequently Asked Questions
Who can join the NCT06309368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06309368 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06309368 currently recruiting?
Yes, NCT06309368 is actively recruiting participants. Contact the research team at abigail.cheng@unlv.edu for enrollment information.
Where is the NCT06309368 trial being conducted?
This trial is being conducted at Las Vegas, United States.
Who is sponsoring the NCT06309368 clinical trial?
NCT06309368 is sponsored by University of Nevada, Las Vegas. The principal investigator is Ovunc Bardakcioglu, MD at Kirk Kerkorian School of Medicine at UNLV. The trial plans to enroll 84 participants.