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Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
NCT06489431 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Rifampin
- DRUG Gentamicin
- DRUG Chlorhexidine
Study Locations (3)
Illinois
- Rush University Medical Center — Chicago
- Uropartners Surgery Center — Des Plaines
California
- Urological Surgeons of Northern California — Mountain View
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06489431
The ClinicalTrials.gov registry entry for NCT06489431 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 168 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Erectile Dysfunction appearing as the primary indexed condition, and to 3 interventions — of which Rifampin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06489431 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06489431 about?
NCT06489431 is a clinical study titled "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.
What is the current status of trial NCT06489431?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2023-12-04. Estimated completion is 2027-12-31.
What conditions does trial NCT06489431 study?
This clinical trial studies the following conditions: Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06489431?
The interventions under investigation include: Rifampin (DRUG), Gentamicin (DRUG), Chlorhexidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06489431?
This trial is sponsored by Rush University Medical Center, which has 168 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06489431 being conducted?
This trial has 3 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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