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NCT06489431 · ClinicalTrials.gov registry record · Phase 3
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
A Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, sponsored by Rush University Medical Center.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT06489431: Active Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, sponsored by Rush University Medical Center.
NCT06489431 is a Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 200 participants, below the 226-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (12% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06489431, a Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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
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 |
What the registry record for NCT06489431 still lists
NCT06489431 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 226-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (12% lower).
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.
NCT06489431 reports a single indexed study location in Illinois, California.
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.
What interventions are being tested in trial NCT06489431?
The interventions under investigation include: Rifampin (DRUG), Gentamicin (DRUG), Chlorhexidine (DRUG).
Who is sponsoring clinical trial NCT06489431?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06489431's enrollment target sits among peer trials
200 10th of 33 higher than 24 of 33 other Erectile Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Erectile Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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