Ostomy Primary Closure With 0.1% Betaine/0.1% Polyhexanide Wound Irrigation Compared to Pursestring Closure

RECRUITING

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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.

Conditions:

🦠 Surgical Site Infection 🦠 Wound Surgical 🦠 Colorectal Disorders

🗓️ Study Start (Actual) 14 March 2024

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) December 2025

👥 Enrollment (Estimated) 84

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE4

Locations:

📍 Las Vegas, Nevada, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* All patients 18 years or older with an ostomy reversal indication will be enrolled

Exclusion Criteria:

* Patients under 18 years old and patients unable to provide consent

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 22 February 2024
First Submitted that Met QC Criteria 6 March 2024
First Posted 13 March 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 21 March 2024
Last Update Posted 25 March 2024
Last Verified March 2024