Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489431
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement A Prospective Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
To conduct a prospective randomized controlled trial of all virgin penile prosthesis implantations with the goal of assessing Irrisepts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None