NCT06489431

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

To conduct a prospective, randomized, controlled trial of all virgin penile prosthesis implantations with the goal of assessing Irrisept's candidacy as an alternative to traditional antibiotic irrigation (Rifampin, Gentamicin for all patients, with the addition of Amphotericin B if patient has a history of diabetics) during penile prosthesis surgery. The investigators believe that Irrisept provides adequate antibacterial and antifungal coverage to serve as an alternative to traditional antibiotic therapy. Additionally, the investigators believe a cost analysis would support the use of Irrisept in the event that non-inferiority is demonstrated.

Conditions

• Erectile Dysfunction
• Penile Prosthesis; Complications, Infection or Inflammation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-05-31
• Completion: 2027-12-31
• First posted: 2024-07-05
• Last updated: 2026-01-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study