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Antiseptic Solution

Wound Irrigation vs Pursestring Closure for Ostomy Wounds

Phase 4
Recruiting
Led By Ovunc Bardakcioglu, MD
Research Sponsored by University of Nevada, Las Vegas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-operatively.
Awards & highlights

Summary

This trial aims to compare two methods of closing ostomy wounds in patients who are ready for closure. They will compare the rates of infection, quality of life, and time to wound healing between patients who

Who is the study for?
This trial is for patients with ostomies ready to be closed. It's not specified who can't join, but typically, participants would need to be in good health otherwise and not have conditions that could affect wound healing or increase infection risk.
What is being tested?
The study compares two methods of closing ostomy wounds: one uses a wash called Prontosan before complete closure, while the other uses a Pursestring method leaving the wound partially open. The focus is on infection rates, patient quality of life, and speed of healing.
What are the potential side effects?
Potential side effects are likely related to surgery and may include pain at the site, risk of infection, delayed wound healing or reopening of the wound. Specific side effects from Prontosan might include skin irritation or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-operatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post-operatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical Site Infection Rates
Secondary study objectives
Acceptability of wound and scar healing by patient
Wound healing

Trial Design

2Treatment groups
Active Control
Group I: Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound IrrigationActive Control1 Intervention
The ostomy wound will be irrigated with 0.1% Betaine/0.1% Polyhexanide wound irrigation, then closed completely with sutures.
Group II: Secondary Closure with PursestringActive Control1 Intervention
The ostomy wound will be partially closed using the Pursestring method.

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Who is running the clinical trial?

University of Nevada, Las VegasLead Sponsor
70 Previous Clinical Trials
13,904 Total Patients Enrolled
Ovunc Bardakcioglu, MDPrincipal InvestigatorKirk Kerkorian School of Medicine at UNLV
1 Previous Clinical Trials
26 Total Patients Enrolled
~21 spots leftby Dec 2024
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