(034) Long Term Safety of Filling Hydrophilic Coated Implants With the 0.05% Chlorhexidine Gluconate Antiseptic: ‘The Kinder Egg Effect’ 1 Year Clinical Data

Abstract Introduction Due to the many advancements in inflatable penile prosthesis (IPP) surgery, including infection retardant coatings, infection rates are now 1-3%. Although, revision IPP infection is much higher ranging from 7-18% in published literature, which are presumably secondary to biofilm. It has also been shown that revision infections can be reduced to 2.86% with washout at time of explant. Neither IPP manufacturer is immune from mechanical malfunction. In Coloplast (CP) implants virtually all failures are due to tubing fracture, which results in a fluid collection within the fibrous surgical capsule. This provides a unique opportunity for the surgeon to pre-treat the biofilm and potentially reduce infection rates during revision surgery. Recent in vitro data suggests that filling the IPP with 0.05% Chlorhexidine gluconate (CHG) (Irrimax Corp, Lawrenceville, GA, USA) is not harmful to the CP Titan® (Coloplast, Minneapolis, MN, USA) hydrophilic device. Objective We aim to assess 1 year clinical outcomes from 2 centers after filling all IPPs with 0.05% CHG. Our long-term objective is to assess culture positivity during revision surgery due to mechanical failure. Methods A two-center, IRB approved (WCG IRB #20220053), retrospective chart review was performed. We analyzed primary and revision IPP cases from May 2024 to May 2025. All devices were hydrophilic IPPs from CP. Surgeon 1 uses only an infrapubic approach while Surgeon 2 uses only a penoscrotal approach. Both surgeons are high volume implanters, use the classic Titan pump, and only use 0.05% CHG for dip/irrigation. All patients received perioperative IV antibiotics. Surgeon 1 used IV vancomycin and gentamicin. Surgeon 2 used IV clindamycin, gentamicin, and fluconazole. All devices were primed and filled with 0.05% CHG. Categorical variables were assessed with Chi-square analysis as we were interested in mechanical failure or not and infection or not. Results There was a total of 205 IPP surgeries over the study period. Breakdown can be seen in Figure 1. Surgeon 1 performed 63 primary and 26 revisions. Surgeon 2 performed 89 primary and 27 revisions. There was one infection for each surgeon 2/205 (1%). The infection for surgeon 1 was a revision case and the wound culture grew Staphylococcus lugdenesis. A malleable implant salvage technique (MIST) was performed. The infection for surgeon 2 occurred in a primary IPP with wound and DNA cultures showing Escherichia coli. Surgeon 2 did not perform a MIST. There were no mechanical failures for either surgeon. Complications were significantly higher in the revision group 6/53 (11.3%) vs the primary group 3/152 (2%) with a p-value=0.004. Infection incidence was not significant between primary and revision cases 1/152 (0.7%) and 1/53 (1.9%); p-value=0.433. Conclusions Filling and priming hydrophilic IPPs with 0.05% CHG appears safe and has not resulted in mechanical device failure at one year. This is congruent with our prior in vitro study and is further hypothesized to reduce culture positivity at IPP revision surgery for mechanical failure. However, further clinical studies and longer follow up are needed to solidify these statements. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Irrimax Scientific advisory board, Coloplast and Boston Scientific consultants