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OpenTrials
Active, Not Recruiting

NCT Number: NCT06489431

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Infections Inflammation Male Urogenital Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Prosthesis; Complications, Infection or Inflammation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Urological Surgeons of Northern California, Mountain View, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine

Drug

Irrisept is a self-contained jet lavage that contains chlorhexidine gluconate (CHG) as a preservative to offer broad-spectrum activity against various microorganisms in the bottled solution

Other names: Irrisept

Gentamicin

Drug

Aminoglycoside antibiotic irrigation

Other names: Gentak

Rifampin

Drug

Antibacterial known to inhibit DNA-dependent RNA polymerase

Other names: rifampicin, Rifadin

Primary outcomes

  1. Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Irrimaxcorp
  • Urological Surgeons of Northern California

Registry information

Official study title

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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