Although implantation of inflatable penile prostheses is a well-accepted treatment for erectile dysfunction refractory to medical management, post-operative infection of the prosthesis remains one of the most dreaded complications of this procedure. An infected penile prosthesis needs to be completely removed and replaced. This is very traumatic for the patient. In addition, some estimates place the cost of treating an infected prosthesis 6 times higher than the cost of the prosthesis. Despite peri-operative antibiotics and vigorous attention to sterile technique, infection rates have remained relatively stable over the last few decades. Infection rates also tend to be under-reported especially when the procedure is performed by less experienced physicians.Studies have identified that most infections of implanted devices are associated with organisms that colonize the patient’s skin: Staphylococcus epidermidis, aureus, and Candida albicans. Efforts at reducing infection rates have primarily focused on killing the offending organisms at the time of surgery (e.g., peri-operative antibiotics, Povidone scrub, antibiotic irrigation etc. (ambien) ). Recently, an antibiotic-coated prosthesis has been introduced that targets the production of biofilm on the prosthesis material.¹
Results of No-Touch Technique
Number of cases since registry was started in 2002: 4841Number of cases with No-Touch Technique since January of 2006: 3989 Infection rate with No-Touch updated 10/15/19: 0.6%
*Saline irrigation without antibioticInfection is the most dreaded complication. Infection retardant coatings on modern implants have lowered the infection rate drastically. This retrospective but prospectively followed single center study explores whether a No-Touch enhancement to the surgical technique of IPP will further decrease infection rates. The No-Touch Technique ensures that neither the surgeon, the instruments, nor the implant touch the patient’s skin.
In our initial publication of the No-Touch Technique, five of the 537 patients undergoing a No-Touch insertion of penile prosthesis subsequently developed an infection. All infections presented within three to six weeks following the procedure and were diagnosed by the presence of skin tethering and pain upon manipulation of the pump. Cultures were taken from all components of the device and the peri-prosthetic space at the time of prosthesis removal.
Coated Implants and No-Touch Surgical Technique Decreases Risk of Infection in Inflatable Penile Prosthesis Implantation to 0.46%Click here to read the entire article
Discussion
Reported infection rates for inflatable penile prostheses vary but are generally quoted to be between 1.8 to 10% for virgin prostheses and 7 to 21% for replacement prostheses. Recent studies suggest that the use of antibiotic coated prostheses may lead to a reduction in the incidence of peri-prosthetic infection. While this assumption was not specifically tested in our series, it is notable that all five infections occurred in patients who received non-antibiotic coated prostheses. All five patients subsequently underwent successful salvage procedure and had a successful re-implantation of penile prosthesis.It is well known that organisms, which normally thrive on human skin, are responsible for the majority of infections. Indeed, even in uninfected patients who have their prosthesis removed for malfunction, a recent study demonstrated that up to 66% will have positive cultures obtained from swabbing the peri-prosthetic fluid and 55% of those cultures will grow coagulase-negative Staphylococcus. In the five infections in our series, 3 patients grew this organism. This data only underscores the importance of protecting the prosthesis from contamination by organisms that inhabit the skin.The theory of the No-Touch Technique is that reduction of colony counts on the skin with peri-operative antibiotics, cleansers and preps can never eliminate all of the skin flora. Strict isolation of the operative field, instruments, and prosthesis from the skin with the use of the #1012 drape limits the opportunity for cutaneous organisms to establish an infection. The advantage of the lose #1012 drape over the commonly used Vi drape is that it allows the operator to manipulate the pump in the scrotum and test the rigidity of the erection once the penile components are placed without coming into contact with the skin.Our infection rate of 0.91% using this technique, inclusive of both virgin and replacement implants, is below even the lowest reported infection rates in the literature. While a prospective study comparing standard sterility techniques to the No-Touch Technique is needed to establish statistical significance, we believe that our low infection rate demonstrates the clinical significance of the technique.
References
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- Henry, G. D. et al. Revision washout decreases penile prosthesis infection in revision surgery: A multicenter study. J Urol 173: 89, 2005.
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- Wilson, S.K., Zumbe, J., Henry, G.D., Salem, E.A., Delk, J.R., and Cleves, M.A. Infection reduction using antibiotic-coated inflatable penile prosthesis. Urol 70 (2): 337, 2007.
- Henry, G.D., Carson, C.C., Wilson, S.K., Wiygul, J., Tornehl, C., Cleves, M.A., Simmons, C.J., and Donatucci, C.F. Revision washout decreases implant capsule tissue culture positivity: A multicenter study. J Urol 179: 186, 2008.