The Impact of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.

The Ohio State University

Status: Enrolling

Conditions: Antibiotic; Urinary Tract Infection; Catheter Infection

Treatments: Other: 0.05% Chlorhexidine Gluconate; Other: Normal Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07239219

STUDY20250670

Details and patient eligibility

About

Given the high burden of post-catheter removal UTIs, this study aims to evaluate Irrisept instillation as a non-antibiotic intervention to reduce infection rates. By comparing Irrisept to saline irrigation, the study will provide critical insights into the efficacy of antiseptic bladder irrigation in preventing UTIs while minimizing antibiotic use. If successful, this approach could lead to new clinical guidelines for catheter removal protocols, improving patient outcomes and reducing healthcare costs.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Presenting to the urology clinic for catheter removal
2. Must be 18 years or older.
3. The patient must be able to understand and willing to provide informed consent as described in this study protocol.
4. Must be willing to complete a post-catheter removal survey

Exclusion criteria

1. Allergy or adverse reaction to chlorohexidine gluconate
2. Under the age of 18
3. Refuse to provide informed consent
4. On antibiotic therapy for any indication.
5. Women who are pregnant or breastfeeding
6. Signs of skin or systemic infection
7. Patients undergoing catheter exchange

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard of care

Treatment:

Other: Normal Saline

Experimental

Experimental group

Description:

Experimental

Treatment:

Other: 0.05% Chlorhexidine Gluconate