RECRUITING
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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.
Conditions:
🦠 Erectile Dysfunction 🦠 Penile Prosthesis; Complications, Infection or Inflammation
🗓️ Study Start (Actual) 4 December 2023
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 June 2024
  • First Submitted that Met QC Criteria 28 June 2024
  • First Posted 5 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 5 July 2024
  • Last Verified June 2024
I'm interested ...!!