Health TrialsbyHealthPanel

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

ConditionsUrinary Tract InfectionAntibioticCatheter Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Allergy or adverse reaction to chlorohexidine gluconate

Under the age of 18

Refuse to provide informed consent

On antibiotic therapy for any indication.

Trial design

Design model

Single group

Treatments tested in this trial

  • 0.05% Chlorhexidine Gluconate

    Other intervention

    0.05% CHG is instilled into the bladder prior to trial of void.

  • Normal Saline

    Other intervention

    Bladder is back filled with normal saline.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Urinary tract infection

Evaluate the rate of urinary tract infection after urethral catheter removal.

Time frame
30 days

Secondary outcomes

1

Antibiotic use

Evaluate the rates of antibiotic use 30 days after urethral catheter removal

Time frame
30 days
2

Adverse Events

Evaluate the rates of adverse events 30 days after urethral catheter removal

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Irrimax Corporation

Collaborator

Source ClinicalTrials.gov
Apply now