Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified November 2025 by Rush University Medical Center
Sponsor
Rush University Medical Center
Information Provided by (Responsible Party)
Rush University Medical Center
Clinicaltrials.gov Identifier
NCT06489431
Other Study ID Numbers:
21120903
First Submitted
June 27, 2024
First Posted
July 4, 2024
Last Update Posted
January 4, 2026
Last Verified
November 2025

ClinicalTrials.gov processed this data on December 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Erectile DysfunctionPenile Prosthesis; Complications, Infection or Inflammation
Drug: GentamicinDrug: Chlorhexidine

Study Design

Study TypeInterventional
Actual Enrollment200 participants
Design AllocationRandomized
Interventional ModelSingle Group Assignment
MaskingSingle
Primary PurposePrevention
Official TitleIrrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial
Study Start DateDecember 3, 2023
Actual Primary Completion Date1w 2d from now
Actual Study Completion Date1yr 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Traditional Antibiotic Therapy
Preoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with traditional antibiotics (rifampin, gentamycin, +/-fluconazole) immediately after the space is created in all cases. An additional scrotal irrigation with traditional antibiotics after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.
Drug: Gentamicin
Aminoglycoside antibiotic irrigation
Irrisept only irrigation
Preoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with Irrisept only immediately after the space is created in all cases. An additional scrotal irrigation with Irrisept only after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.
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

Outcome Measures

Primary Outcome Measures
  1. Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only
    All patients will be closely followed with appointments at regular intervals for the first year after surgery to monitor for infections as per usual care

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersYes
Inclusion Criteria
Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)
Exclusion Criteria
Exclusion criteria include men who are having revision implant surgeries, men who may require intraoperative complex reconstruction including graft for Peyronie's Disease, and transgender males

Contacts and Locations

Sponsors and CollaboratorsRush University Medical Center
Locations
Urological Surgeons of Northern California | Mountain View California, United States, 94035Rush University Medical Center | Chicago Illinois, United States, 60612Uropartners Surgery Center | Des Plaines Illinois, United States, 60018
Investigators
Principal Investigator: Edward Cherullo, MD, Rush UniversityPrincipal Investigator: Laurence Levine, MD, Rush University