← Back to Search

Antibiotic

Irrisept vs Antibiotics for Penile Prosthesis Placement

Phase 3

Recruiting

Led By Edward Cherullo, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)

Must not have

Men who are having revision implant surgeries

Transgender males

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

"This trial aims to see if using Irrisept during surgery is as effective as using multiple antibiotics when inserting a penile prosthesis for the first time."

Who is the study for?

This trial is for men getting their first penile prosthesis implant, regardless of the brand. It's not for those needing complex surgery like grafts for Peyronie's Disease, men having revision surgeries, or transgender males.

What is being tested?

The study is testing if Irrisept irrigation during surgery is as good as using multiple antibiotics (Gentamicin, Rifampin, Chlorhexidine) to prevent infection in new inflatable penile prosthesis devices.

What are the potential side effects?

Potential side effects may include allergic reactions to Chlorhexidine such as skin rash or irritation; Gentamicin and Rifampin could cause kidney issues or hearing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am getting a penile prosthesis implant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a man scheduled for a revision implant surgery.

Select...

I am a transgender male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT02252588

Other oral side effects

100%

80%

60%

40%

20%

Study treatment Arm

Chlorhexidine

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Irrisept only irrigationExperimental Treatment1 Intervention

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.

Group II: Traditional Antibiotic TherapyActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chlorhexidine

2013

Completed Phase 4

~9050

0 / 3Eligibility criteria met