Clinical trial NCT06489431: Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
Official title: Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Erectile Dysfunction
Penile Prosthesis; Complications, Infection or Inflammation
Keywords: Inflatable Penile Prosthesis
Irrisept
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Non inferiority trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Des Plaines
country: United States
facility: Uropartners Surgery Center
state: Illinois
Study officials:
affiliation: Rush University
name: Edward Cherullo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University
name: Laurence Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karpman E, Griggs R, Twomey C, Henry GD. Dipping Titan implants in Irrisept solution (0.05% chlorhexidine gluconate) and exposure to various aerobic, anaerobic, and fungal species. J Sex Med. 2023 Jun 28;20(7):1025-1031. doi: 10.1093/jsxmed/qdad055.
citation: O'Donnell JA, Wu M, Cochrane NH, Belay E, Myntti MF, James GA, Ryan SP, Seyler TM. Efficacy of common antiseptic solutions against clinically relevant microorganisms in biofilm. Bone Joint J. 2021 May;103-B(5):908-915. doi: 10.1302/0301-620X.103B5.BJJ-2020-1245.R2.
citation: Markel JF, Bou-Akl T, Dietz P, Afsari AM. The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. Arthroplast Today. 2021 Jan 19;7:120-125. doi: 10.1016/j.artd.2020.11.004. eCollection 2021 Feb.
citation: O'Donnell JA, Wu M, Cochrane NH, Belay E, Myntti MF, James GA, Ryan SP, Seyler TM. Efficacy of Common Antiseptic Solutions Against Clinically Relevant Planktonic Microorganisms. Orthopedics. 2022 Mar-Apr;45(2):122-127. doi: 10.3928/01477447-20211227-05. Epub 2022 Jan 3.
citation: Siddiqi A, Abdo ZE, Springer BD, Chen AF. Pursuit of the ideal antiseptic irrigation solution in the management of periprosthetic joint infections. J Bone Jt Infect. 2021 May 26;6(6):189-198. doi: 10.5194/jbji-6-189-2021. eCollection 2021.
citation: Kia C, Cusano A, Messina J, Muench LN, Chadayammuri V, McCarthy MB, Umejiego E, Mazzocca AD. Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis. J Shoulder Elbow Surg. 2021 Sep;30(9):2177-2183. doi: 10.1016/j.jse.2020.12.009. Epub 2021 Jan 30.
citation: Wosnitzer MS, Greenfield JM. Antibiotic patterns with inflatable penile prosthesis insertion. J Sex Med. 2011 May;8(5):1521-8. doi: 10.1111/j.1743-6109.2011.02207.x. Epub 2011 Feb 24.