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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
• Signed consent
Locations
United States
Nevada
University Medical Center
RECRUITING
Las Vegas
Contact Information
Primary
Abigail W Cheng, MD
abigail.cheng@unlv.edu
9166954159
Backup
Lance Horner, MD
lance.horner@unlv.edu
7755445456
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2029-12
Participants
Target number of participants: 84
Treatments
Active_comparator: Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation
The ostomy wound will be irrigated with 0.1% Betaine/0.1% Polyhexanide wound irrigation, then closed completely with sutures.
Active_comparator: Secondary Closure with Pursestring
The ostomy wound will be partially closed using the Pursestring method.
Related Therapeutic Areas
Sponsors
Leads: University of Nevada, Las Vegas