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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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
Aminoglycoside antibiotic irrigation
Antibacterial known to inhibit DNA-dependent RNA polymerase
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
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
Time frame: 1-2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.