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Antiseptic Solution
Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation for Surgical Site Infection
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
Study 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.Check my eligibility
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical Site Infection Rates
Secondary outcome measures
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
66 Previous Clinical Trials
13,715 Total Patients Enrolled
Ovunc Bardakcioglu, MDPrincipal InvestigatorKirk Kerkorian School of Medicine at UNLV
1 Previous Clinical Trials
26 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for patients to participate in this research study?
"As per clinicaltrials.gov, the present trial is not actively seeking subjects. It was first listed on March 1st, 2024, and last revised on March 6th, 2024. Despite this trial being inactive, there are currently a total of 1582 other trials welcoming new participants."
Answered by AI
What is the safety profile of using Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation in medical practice?
"Our team at Power assessed the safety of Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation to be a 3 on our scale, indicating high safety due to its approval status in this Phase 4 trial."
Answered by AI
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