Clinical Trial

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-06-28; most recent amendment 2026-07-23.
Status change: Suspended → Active, Not Recruiting 2025-12-08
Status change: Recruiting → Suspended 2025-02-10
Trial Details
NCT Number NCT06489431
Lead Sponsor Rush University Medical Center
Collaborators: Irrimaxcorp, Urological Surgeons of Northern California
Conditions Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation
Enrollment 200 participants
Start Date 2023-12-04
Primary Completion 2026-05-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-24