Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Last updated: February 10, 2025
Sponsor: Rush University Medical Center
Overall Status: Suspended

Phase

3

Condition

Inflammation

Male Hormonal Deficiencies/abnormalities

Erectile Dysfunction

Treatment

Rifampin

Gentamicin

Chlorhexidine

Clinical Study ID

NCT06489431
21120903
  • Male
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria include all men undergoing penile prosthesis (any manufacturer)implantation (inpatient or outpatient)

Exclusion

Exclusion Criteria:

  • Exclusion criteria include men who are having revision implant surgeries, men whomay require intraoperative complex reconstruction including graft for Peyronie'sDisease, and transgender males

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Rifampin
Phase: 3
Study Start date:
December 04, 2023
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Uropartners Surgery Center

    Des Plaines, Illinois 60018
    United States

    Site Not Available

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