Comparing 0.05% chlorhexidine gluconate monotherapy to conventional antibiotic irrigation in de-novo penile prosthesis implantation: a two-center prospective randomized controlled non-inferiority study (preliminary results).

Abstract

Background: Infection remains a significant concern following penile prosthesis (PP) implantation surgery. Published guidelines have indicated the use of pre-operative intravenous (IV) antibiotics but have not provided specific recommendations regarding intra-operative irrigation. For long in our practice, we have been using a combination of antibiotics for irrigation (rifampin 600 mg/L of sterile water, gentamicin 80 mg/L of sterile water). Recently, 0.05% chlorhexidine gluconate (CHG) (Irrisept^®) (Irrimax Corp, Lawrenceville, GA, USA), has shown promise as an alternative irrigant, with potential advantages in terms of cost, ease of administration and reduced antibiotic resistance risk. The study aims to assess the non-inferiority of CHG antiseptic irrigation compared to conventional combined antibiotic irrigation in preventing postoperative infections for men undergoing de-novo PP implantation.

Methods: This is a two-center Institutional Review Board (IRB) approved prospective randomized controlled non inferiority trial, involving men undergoing de-novo PP implantation with a predetermined non-inferiority margin of 4%. Patients were randomly assigned into one of two groups: the CHG irrigation or the group receiving conventional antibiotic irrigation. All patients received IV antibiotics preoperatively and were sent home on oral antibiotics for 2 weeks post-operatively. The primary endpoint of this trial was to evaluate the incidence of PP infections. Secondary objectives encompassed the assessment of simplicity of use and cost-effectiveness.

Results: A hundred patients were enrolled in our study so far (50 in each arm). Only one case of PP infection necessitating explanation was reported in each arm. Moreover, the use of CHG irrigation offered the potential advantages of ease of administration and less cost as compared to antibiotic irrigation solutions.

Conclusions: Preliminary data from this non-inferiority study demonstrate that CHG irrigation is non-inferior to conventional antibiotic irrigation in preventing postoperative infection following PP implantation. These findings support the consideration of CHG irrigation as a viable alternative during PP implantation, offering both clinical effectiveness and potential cost savings as well as reducing the risk of antibiotic resistance.

Trial registration: ClinicalTrials.gov NCT06489431.