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Active Not Recruiting
NCT06489431
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
Conditions: Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation
Sex: Male
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 200
Sponsor: Rush University Medical Center
Location: Urological Surgeons of Northern California Mountain View California
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06489431). StuddyBuddy aggregates publicly available trial information.
