Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation
Conditions
Keywords
Inflatable Penile Prosthesis, Irrisept
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 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.
Interventions
DRUGChlorhexidine
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
DRUGGentamicin
Aminoglycoside antibiotic irrigation
DRUGRifampin
Antibacterial known to inhibit DNA-dependent RNA polymerase
Sponsors
Rush University Medical Center
Irrimaxcorp
Urological Surgeons of Northern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be aware of the two options, however will be randomly selected to receive only one of the two treatments. Investigators will be aware of the treatment as they are administering it
Intervention model description
Non inferiority trial
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREdward Cherullo, MD
Rush University
PRINCIPAL_INVESTIGATORLaurence Levine, MD
Rush University
Outcome results
None listed