Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Published:

Zero infection protocol in inflatable penile prosthesis surgery: a prospective cohort study using chlorhexidine-alcohol skin preparation and fibrin sealant hemostasis

Abstract

Surgical site infections remain a devastating complication of inflatable penile prosthesis (IPP) implantation. We evaluated a novel surgical protocol combining chlorhexidine-alcohol skin preparation with fibrin sealant-mediated hemostasis and no drain placement, hypothesizing that it would reduce infection and hematoma rates. Between January 2020 and December 2023, 103 men underwent primary IPP placement with a protocol of 2% chlorhexidine gluconate/70% isopropyl alcohol (ChloraPrep®) skin antisepsis and intraoperative application of Evicel® fibrin sealant to corporotomy suture lines, subcutaneous tissues, and pump pocket. This group was compared with 115 historical controls who received povidone iodine skin preparation only and routine surgical drains between January 2015 to December 2019. The primary endpoint was IPP infection at 12 months; secondary endpoints included hematoma rate, operative time, length of stay, and patient satisfaction. No infections occurred in the study cohort (0/103), compared to 3.5% (4/115) of controls (p < 0.001). Hematoma incidence was 1.0% (1/103) versus 5.2% (6/115) in controls (p = 0.03). Mean operative time (52.4 ± 13.8 min vs. 58 ± 18 min, p = 0.12) was similar between groups, while same-day discharge rates were higher in the study cohort (94.7 vs. 88.0%, p = 0.03). Combining chlorhexidine-alcohol skin antisepsis with fibrin sealant hemostasis and eliminating drains is a viable option to reduce infections and hematomas in IPP surgery.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Fig. 1
Fig. 2

Similar content being viewed by others

Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Carson CC, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup. J Urol. 2011;185:614–8.

    Article  PubMed  Google Scholar 

  2. Eid JF, Wilson SK, Cleves M, Salem EA. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology. 2012;79:1310–5.

    Article  PubMed  Google Scholar 

  3. Licht MR, Montague DK, Angermeier KW, Lakin MM. Cultures from genitourinary prostheses at re-operation: questioning the role of staphylococcus epidermidis in periprosthetic infection. J Urol. 1995;154:387.

    Article  CAS  PubMed  Google Scholar 

  4. Lotan Y, Roehrborn, McConnell JD, Hendin BN. Factors influencing the outcomes of penile prosthesis surgery at teaching institution. Urology. 2003;62:918.

    Article  PubMed  Google Scholar 

  5. Henry GD, Wilson SK, Delk JR 2nd, Carson CC, Wiygul J, Tornehi C, et al. Revision washout decreases penile prosthesis infection in revision surgery: a multicenter study. J Urol. 2005;173:89–92.

    Article  PubMed  Google Scholar 

  6. Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med. 2010;362:18–26.

    Article  CAS  PubMed  Google Scholar 

  7. Swenson BR, Hedrick TL, Metzger R, Bonatti H, Pruett TL, Sawyer RG. Effects of preoperative skin preparation on postoperative wound infection rates: a prospective study of 3 skin preparation protocols. Infect Control Hosp Epidemiol. 2009;30:964–71.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Desouky E, Tsambarlis P, Levine LA. 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). Transl Androl Urology. 2024;13:1905–11.

    Article  Google Scholar 

  9. Garber BB, Bickell M. Delayed postoperative hematoma formation after inflatable penile prosthesis implantation. J Sex Med. 2015;12:265–9.

    Article  CAS  PubMed  Google Scholar 

  10. Braun AE, Swerdloff D, Sudhakar A, Patel RD, Gross MS, Simhan J. Defining the incidence and management of postoperative scrotal hematoma after primary and complex three-piece inflatable penile prosthesis surgery. Int J Impot Res. 2025;37:82–86.

    Article  PubMed  Google Scholar 

  11. Rezaee ME, Towe M, Osman MM, Huynh LM, El-Khatib FM, Andrianne R, et al. A multicenter investigation examining American urological association recommended antibiotic prophylaxis vs nonstandard prophylaxis in preventing device infections in penile prosthesis surgery in diabetic patients. J Urol. 2020;204:969–75.

    Article  PubMed  Google Scholar 

  12. Moldovan H, Antoniac I, Gheorghiță D, Safta MS, Preda S, Broasca M, et al. Biomaterials as haemostatic agents in cardiovascular surgery: review of current situation and future trends. Polymers. 2022;14:1189.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370:1453-7.

    Article  Google Scholar 

  14. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K, et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology. 1999;53:793–9.

    Article  CAS  PubMed  Google Scholar 

  15. Kapadia BH, Elmallah RK, Mont MA. A randomized, clinical trial of preadmission chlorhexidine skin preparation for lower extremity total joint arthroplasty. J Arthroplasty. 2016;31:2856–61.

    Article  PubMed  Google Scholar 

  16. Karpman E, Griggs R, Twomey C, Henry GD. Dipping Titan implants in Irrisept® solution (0.05% chlorhexidine gluconate) and exposure to various aerobic, anaerobic, and fungal species. J Sex Med. 2023;20:1025–31.

    Article  CAS  PubMed  Google Scholar 

  17. Vintimilla DR, Chambers L, Mauffrey C, Parry JA. Just add water? Chlorhexidine’s antimicrobial properties are minimally affected by dilution in saline compared to water. Eur J Orthop Surg Traumatol. 2020;30:613–5.

    Article  PubMed  Google Scholar 

  18. Irrisept Chlorhexidine Gluconate 0.05% Irrigation Solution, 450 mL Bottle [price catalog]. Northfield, IL: Medline Industries, Inc.; 2024. [Accessed May 24, 2024]. Available from: https://www.medline.com.

  19. Sadeghi-Nejad H, Ilbeigi P, Wilson SK, Delk JR, Siegel A, Seftel AD, et al. Multi-institutional outcome study on the efficacy of closed-suction drainage of the scrotum in three-piece inflatable penile prosthesis surgery. Int J Impot Res. 2005;17:535–8.

    Article  CAS  PubMed  Google Scholar 

  20. Spotnitz WD, Burks S. Hemostats, sealants, and adhesives: components of the surgical toolbox. Transfusion. 2008;48:1502–16.

    Article  PubMed  Google Scholar 

  21. Sebbane N, Abramovitz I, Kot-Limon N, Steinberg D. Mechanistic Insight into the anti-bacterial/anti-biofilm effects of low chlorhexidine concentrations on enterococcus faecalis-in vitro study. Microorganisms. 2024;12:2297.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Moukhtar Hammad MA, Barham DW, Stanford DI, Amini E, Jenkins L, Yafi FA. Maximizing outcomes in penile prosthetic surgery: exploring strategies to prevent and manage infectious and non-infectious complications. Int J Impot Res. 2023;35:613–9.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Mandava SH, Serefoglu EC, Freier MT, Wilson SK, Hellstrom WJ. Infection retardant coated inflatable penile prostheses decrease the incidence of infection: a systematic review and meta-analysis. J Urol. 2012;188:1855–60.

    Article  PubMed  Google Scholar 

  24. Scardino M, Martorelli F, D’Amato T, Fenocchio G, Simili V, Grappiolo G, et al. Use of a fibrin sealant within a blood-saving protocol in patients undergoing revision hip arthroplasty: effects on post-operative blood transfusion and healthcare-related cost analysis. Int Orthop. 2019;43:2707–14.

    Article  PubMed  Google Scholar 

  25. Mirheydar HS, Palazzi KL, Parsons JK, Chang D, Hsieh TC. Hospital-based trends in penile prosthetic surgery. J Sex Med. 2015;12:1092–8.

    Article  PubMed  Google Scholar 

  26. Andino JJ, Leelani N, Sato R, Shin Y, Rojanasarot S, Furtado T, et al. Association between surgeon procedure volume and reoperation rates for penile prosthesis implantation. J Sex Med. 2025;22:916–23.

    Article  PubMed  Google Scholar 

  27. Schulz S, Khan A, Evans J, Charles BR, Parnes N, Scanaliato JP. Estimated cost of fibrin glue. J Orthop Bus. 2024. https://doi.org/10.55576/job.v4i2.56

    Article  Google Scholar 

  28. Schindl M, Függer R, Götzinger P, Langle F, Zitt M, Stattner S, et al. Randomized clinical trial of the effect of a fibrin sealant patch on pancreatic fistula formation after pancreatoduodenectomy. Br J Surg. 2018;105:811–9.

    Article  CAS  PubMed  Google Scholar 

Download references

Funding

The authors have no funding to declare.

Author information

Authors and Affiliations

Authors

Contributions

Ali Fathollahi Writing- Original draft preparation, Data curation, Formal Analysis, Writing- Review & Editing. Shirin Razdan: Review & Editing, Validation, Methodology. Sanjay Razdan: Providing the data, Writing- Review & Editing. All authors discussed the results and contributed to the final paper.

Corresponding author

Correspondence to Sanjay Razdan.

Ethics declarations

Competing interests

The authors declare no competing interests.

Ethics approval

This study was performed in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments. Ethical approval was granted by the Institutional Review Board of HCA Florida Kendall Hospital (IRB-41-2930). Informed consent was obtained from all individual participants included in the study. Written informed consent for publication of the clinical images (Fig. 1) was obtained from the participant.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Fathollahi, A., Razdan, S. & Razdan, S. Zero infection protocol in inflatable penile prosthesis surgery: a prospective cohort study using chlorhexidine-alcohol skin preparation and fibrin sealant hemostasis. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01174-8

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1038/s41443-025-01174-8

Search

Quick links