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Recruiting NCT07239219

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

No phase Interventional Urinary Tract Infection Antibiotic Catheter Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.05% Chlorhexidine Gluconate, Normal Saline.
Who it may be relevant to
Registry conditions: Urinary Tract Infection, Antibiotic, Catheter Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.

Overview

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.

Interventions

  • Other 0.05% Chlorhexidine Gluconate
    0.05% CHG is instilled into the bladder prior to trial of void.
  • Other Normal Saline
    Bladder is back filled with normal saline.

Primary outcome measures

  • Urinary tract infection [Time frame: 30 days]
Secondary outcome measures (2)
  • Antibiotic use [Time frame: 30 days]
  • Adverse Events [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Ohio State University — Columbus

Identifiers

NCT: NCT07239219 · STUDY20250670

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗