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Antiseptic Solution
Wound Irrigation vs Pursestring Closure for Ostomy Wounds
Las Vegas, NV
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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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
See full description
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-operatively.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-operatively.
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
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Find a Location
Closest Location:University Medical Center· Las Vegas, NV
Who is running the clinical trial?
University of Nevada, Las VegasLead Sponsor
79 Previous Clinical Trials
14,556 Total Patients Enrolled
Ovunc Bardakcioglu, MDPrincipal InvestigatorKirk Kerkorian School of Medicine at UNLV
1 Previous Clinical Trials
26 Total Patients Enrolled