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ACTIVE NOT RECRUITING
NCT06489431
PHASE3

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Sponsor: Rush University Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

Official title: Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-12-04

Completion Date

2027-12-31

Last Updated

2026-01-05

Healthy Volunteers

Yes

Interventions

DRUG

Chlorhexidine

Irrisept is a self-contained jet lavage that contains chlorhexidine gluconate (CHG) as a preservative to offer broad-spectrum activity against various microorganisms in the bottled solution

DRUG

Gentamicin

Aminoglycoside antibiotic irrigation

DRUG

Rifampin

Antibacterial known to inhibit DNA-dependent RNA polymerase

Locations (3)

Urological Surgeons of Northern California

Mountain View, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Uropartners Surgery Center

Des Plaines, Illinois, United States