Status:
ACTIVE_NOT_RECRUITING
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Irrimaxcorp
Urological Surgeons of Northern California
Conditions:
Erectile Dysfunction
Penile Prosthesis; Complications, Infection or Inflammation
Eligibility:
MALE
Phase:
PHASE3
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 prosth...
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 irrigat...
Eligibility Criteria
Inclusion
- Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)
Exclusion
- 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
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06489431
Start Date
December 4 2023
End Date
December 31 2027
Last Update
January 5 2026
Active Locations (3)
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1
Urological Surgeons of Northern California
Mountain View, California, United States, 94035
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Uropartners Surgery Center
Des Plaines, Illinois, United States, 60018