Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Erectile Dysfunction Penile Prosthesis; Complications, Infection or Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Non inferiority trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Traditional Antibiotic Therapy

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.

Group Type ACTIVE_COMPARATOR

Gentamicin

Intervention Type DRUG

Aminoglycoside antibiotic irrigation

Rifampin

Intervention Type DRUG

Antibacterial known to inhibit DNA-dependent RNA polymerase

Irrisept only irrigation

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.

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

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

Interventions

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Chlorhexidine

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

Intervention Type DRUG

Gentamicin

Aminoglycoside antibiotic irrigation

Intervention Type DRUG

Rifampin

Antibacterial known to inhibit DNA-dependent RNA polymerase

Intervention Type DRUG

Other Intervention Names

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Irrisept Gentak rifampicin Rifadin

Eligibility Criteria

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Inclusion 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

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes