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Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

NCT06489431 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Irrimaxcorp

    collaborator UNKNOWN

  • Urological Surgeons of Northern California

    collaborator UNKNOWN

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Edward Cherullo, MD · Rush University

  • Laurence Levine, MD · Rush University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-05-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489431 on ClinicalTrials.gov