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Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial
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.
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.
Age
All ages
Sex
MALE
Healthy Volunteers
Yes
Urological Surgeons of Northern California
Mountain View, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Uropartners Surgery Center
Des Plaines, Illinois, United States
Start Date
December 4, 2023
Primary Completion Date
May 31, 2026
Completion Date
December 31, 2027
Last Updated
January 5, 2026
200
ESTIMATED participants
Chlorhexidine
DRUG
Gentamicin
DRUG
Rifampin
DRUG
Lead Sponsor
Rush University Medical Center
Collaborators
NCT07480161
NCT07460960
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07431008