Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Rush

Status and phase: Active, not recruiting; Phase 3

Conditions: Erectile Dysfunction; Penile Prosthesis; Complications, Infection or Inflammation

Treatments: Drug: Chlorhexidine; Drug: Gentamicin; Drug: Rifampin

Study type: Interventional

Funder types: Other

Identifiers

NCT06489431

21120903

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Traditional Antibiotic Therapy

Active Comparator group

Description:

Preoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with traditional antibiotics (rifampin, gentamycin, +/-fluconazole) immediately after the space is created in all cases. An additional scrotal irrigation with traditional antibiotics after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.

Treatment:

Drug: Rifampin

Drug: Gentamicin

Irrisept only irrigation

Experimental group

Description:

Preoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with Irrisept only immediately after the space is created in all cases. An additional scrotal irrigation with Irrisept only after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.

Treatment:

Drug: Chlorhexidine