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Abstract Introduction Inflatable penile prosthesis (IPP) infection prevention IS A CRITICAL CONCERN during penile prosthesis (PP) surgery. Recent literature has called PP IV prophylaxis guidelines into question. Furthermore, these guidelines do not specify practices pertaining to intraoperative implant irrigation. Despite this, many high-volume PP surgeons use a combination of antibiotics for dip and irrigation. Specifically, our group has used rifampin 600mg/mL of sterile water with gentamicin 80mg/mL of sterile water for many years. 0.05% chlorhexidine gluconate (CHG) (Irrsept®) (Irrimax Corp, Lawrenceville, GA, USA), an antiseptic, has been recently shown to be safe as an irrigation solution. It has advantages including reduced cost, ease of application, and reduced antimicrobial resistance risk. Most recently, a comparative in vitro study illustrated that 0.05% CHG is more effective than vancomycin with gentamicin as a dip and irrigation in achieving log reductions in bacterial counts. Prior results from this study in 100 patients also suggests that 0.05% CHG is non-inferior to conventional antibiotic irrigation. Objective This study aims to further assess the non-inferiority of 0.05% CHG compared to conventional combined antibiotic irrigation to prevent postoperative infection in men undergoing primary PP surgery. Methods This two-center, Institutional Review Board (IRB) approved, prospective randomized controlled non-inferiority trial, involves primary PP insertion in men with a predetermined non-inferiority margin of 4%. All patients had informed consent. Men aged 18-70 years old were randomized into one of two groups (Figure 1): 0.05% CHG irrigation and combined conventional antibiotic irrigation. We excluded diabetics with an HbA1c >/= 8%, revision PP surgeries, and those that required extensive additional procedures. Both IPP manufacturers were used; CHG group Titan® (CP) devices (Coloplast, Minneapolis, MN, USA) were dipped and irrigated while CX700® (BSCI) devices (Boston Scientific, Minneapolis, MN, USA) did not undergo dipping. All patients received perioperative IV antibiotics and were sent home on postoperative oral antibiotics for 2 weeks. PP placement was via a penoscrotal (PS) or infrapubic (IP) incision. Our primary endpoint was to analyze the incidence of PP infections. Our secondary outcome included assessment of infection incidence by IPP manufacturer. Results A total of 203 patients were enrolled in our study with 101 and 102 in each arm. Final analysis showed only one PP infection was present in each arm, and this was not significant with a p-value=0.994. One infection occurred in a BSCI device in the antibiotic arm and the other in a Titan device in the Irrisept arm and this was also not significant with a p-value=0.805. 145/203 (71.4%) were placed via a PS incision and 58/203 (28.6%) were placed via an IP incision. 119/203 (58.6%) were CP devices and 84/203 (41.4%) were BSCI devices. 0.05% CHG was also demonstrated to have potential cost reduction and ease of use compared to combined antibiotic irrigation. Conclusions This prospective, randomized non-inferiority trial illustrates that 0.05% CHG irrigation is not inferior to conventional combined antibiotic irrigation consisting of rifampin and gentamicin with regards to primary PP infection prevention. Thus, this study supports the consideration of 0.05% CHG irrigation as an alternative during primary PP implantation. Disclosure Yes, this is sponsored by industry/sponsor: Irrimax Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scietific and Coloplast consultants, Irrisept Scientific Advisory Board
Published in: The Journal of Sexual Medicine
Volume 22, Issue Supplement_4