Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
- Conditions
- Penile Prosthesis; Complications, Infection or InflammationErectile Dysfunction
- Interventions
- Registration Number
- NCT06489431
- Lead Sponsor
- Rush University Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Male
- Target Recruitment
- 100
- Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Irrisept only irrigation Chlorhexidine 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. Traditional Antibiotic Therapy Gentamicin 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. Traditional Antibiotic Therapy Rifampin 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.
- Primary Outcome Measures
Name Time Method Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only 1-2 years 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Uropartners Surgery Center
🇺🇸Des Plaines, Illinois, United States