Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nevada, Las Vegas
About this trial
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
Qualifiers
All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
Signed consent
Disqualifiers
Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy
Trial design
Treatments tested in this trial
- Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation
- Pursestring Closure
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov