Active — Not RecruitingPhase 3

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

United States200 participantsStarted 2023-12-04

Plain-language 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.

Who can participate

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only

Timeframe: 1-2 years

Trial details

NCT IDNCT06489431

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Erectile Dysfunction trials