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You have accessJournal of UrologySexual Function/Dysfunction: Surgical Therapy I (PD46)1 May 2024PD46-01 "COMPARING CHLORHEXIDINE 0.05% ANTISEPTIC MONOTHERAPY TO CONVENTIONAL COMBINED ANTIBIOTIC IRRIGATION DURING PENILE PROSTHESIS IMPLANTATION: A TWO-CENTER PROSPECTIVE RANDOMIZED CONTROLLED NON-INFERIORITY STUDY" (PRELIMINARY DATA) Elsayed Desouky, Peter Tsambarlis, and Laurence A. Levine Elsayed DesoukyElsayed Desouky , Peter TsambarlisPeter Tsambarlis , and Laurence A. LevineLaurence A. Levine View All Author Informationhttps://doi.org/10.1097/01.JU.0001008900.49567.2e.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Infection remains a significant concern following penile prosthesis (PP) implantation surgery. Published guidelines have indicated the use of pre-operative intravenous 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 600mg/L of sterile water, Gentamicin 80 mg/L of sterile water). Recently, 0.05% chlorhexidine gluconate (CHG)- Irrisept® (Irrimax Corp, Lawrenceville, GA), 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 IRB approved prospective randomized controlled trial, involving men undergoing de-novo PP implantation. To date, 85 patients have been successfully enrolled in the study with a predetermined non-inferiority threshold of 100 participants. Patients are 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 x 2 weeks post-operatively. The primary endpoint of this trial is to evaluate the incidence of PP infections within the 90-day post-surgery period. Secondary objectives encompass the assessment of surgical site infections, simplicity of use, and a cost-effectiveness analysis. RESULTS: 85 patients have been enrolled into our study so far; 43 in the CHG arm and 42 in the conventional antibiotic arm. Only one case of PP infection necessitating explanation has been reported in the CHG group. We are still enrolling patients into our Cohort to achieve the non-inferiority margin of 100 patients. From cost effectiveness standpoint, the cost for CHG is less than that for the combined antibiotic irrigation solutions. CONCLUSIONS: Preliminary data from this non-inferiority study demonstrate that CHG irrigation is non-inferior to conventional combined antibiotic irrigation in preventing postoperative infection following PP implantation. Moreover, the use of CHG irrigation offers the potential advantages of ease of administration and theoretically reduces the risk of antibiotic resistance. These findings support the consideration of CHG irrigation as a viable alternative during penile prosthesis implantation, offering both clinical effectiveness and potential cost savings. Source of Funding: N/A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e973 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Elsayed Desouky More articles by this author Peter Tsambarlis More articles by this author Laurence A. Levine More articles by this author Expand All Advertisement PDF downloadLoading ...
Desouky et al. (Mon,) studied this question.