Actively Recruiting
To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal
Led by Ohio State University · Updated on 2025-11-20
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
I
Irrimax Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Irrisept, a 0.05% Chlorhexidine Gluconate solution, to reduce urinary tract infections (UTIs) that can occur after removing a urethral catheter. This study compares Irrisept bladder irrigation to standard saline irrigation to see if the antiseptic solution can lower infection rates without relying on antibiotics. The goal is to find new ways to prevent UTIs and potentially update clinical guidelines for catheter removal, improving patient outcomes and reducing healthcare costs. Participants will be randomly assigned to one of two groups: the experimental group receiving the Irrisept bladder instillation before attempting to urinate, and the control group receiving bladder backfilling with normal saline. This is an interventional study with no masking, meaning both participants and researchers know which treatment is given. The study will follow participants for 30 days after catheter removal to monitor outcomes. During the study, participants will be monitored for urinary tract infections, antibiotic use, and any adverse events occurring within 30 days after catheter removal. Participants must be able to provide informed consent and complete a post-catheter removal survey. The study aims to provide important information on infection prevention and antibiotic stewardship in patients undergoing catheter removal.
CONDITIONS
Brief Title
The Impact of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presenting to the urology clinic for catheter removal
- 18 years of age or older
- Able to understand and willing to provide informed consent
- Willing to complete a post-catheter removal survey
You will not qualify if you...
- Allergy or adverse reaction to chlorhexidine gluconate
- Under 18 years of age
- Refuse to provide informed consent
- Currently on antibiotic therapy for any reason
- Women who are pregnant or breastfeeding
- Signs of skin or systemic infection
- Patients undergoing catheter exchange
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event during catheter removal
Participants receive either 0.05% Chlorhexidine Gluconate instilled into the bladder or normal saline prior to catheter removal as part of the trial intervention.
1 treatment visit (in-person)
Duration - 30 days
Participants are monitored for urinary tract infections, antibiotic use, and adverse events following catheter removal.
Follow-up visits or surveys as scheduled up to 30 days
Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43212-3153
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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