No-Touch Technique

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.). Recently, an antibiotic-coated prosthesis has been introduced that targets the production of biofilm on the prosthesis material.¹



However, Dr. Eid believes that preventing direct contact with the source of bacteria is the most effective way of eliminating infections. Therefore, a novel technique for prosthesis insertion entitled the “no-touch” technique to reduce the incidence of peri-prosthtetic infection was invented. The technique was developed on the belief that eliminating any contact between the prosthesis and the skin, either directly or indirectly via surgical instruments or gloves, should reduce the incidence of contamination of the device with skin flora responsible for infection.

Coated Implants and “No Touch” Surgical Technique Decreases Risk of Infection in Inflatable Penile Prosthesis Implantation to 0.46%

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Results of “No-Touch Technique"

Number of cases:  2953
Infection rate as of 5/2/2013:  1%

Year	Implant #	Infection #	%
2002	132	7	5.3
2003	204	4	2.0
2004	218	3	1.4
2005	298	6	2.0
2006*	247	2	0.8
2007*	282	1	0.4
2008*	226	1	0.4
2009*	300	1	0.3
2010*	305	0	0
2011*	336	2	0.6
2012*	303	2	0.7
2013*	102	0	0

* No touch technique and saline irrigation only

Prior to 2006, Dr. Eid expertly used state-of-the-art infection prevention techniques, achieving low rates of infection comparable to other prominent penile prosthesis surgeons today. 
 
In 2006, Dr. Eid further reduced his infection rate to well below most penile implant surgeons with his innovative No Touch Technique.
 
In 2008, Dr. Eid's infection rate dropped to almost 0% (fewer than 1 in 225 surgeries).

Brief description of the “No-Touch” Surgical Technique for medical professionals

The “No-touch” technique adheres to many of the practices associated with standard surgical sterility. Patients are placed on an oral fluoroquinolone for three days prior to the procedure and instructed to scrub the lower abdomen and genitals daily with chlorhexidine soap. Vancomycin is administered intravenously two hours prior to the start of the procedure. The lower abdomen and genitals are shaved, followed by a 5 minutes Povidone scrub and prep with alcohol and Povidone paste. Surgical drapes are placed, followed by a Vi drape over the genitalia; a capped Foley catheter is inserted. An incision is made in the penoscrotal raffe and the dissection is carried down through the through the subcutaneous tissues to the level of Bucks fascia. A Scott retractor is employed with blunt hooks to maintain exposure.

At this point, the “no touch” principles are employed. The procedure is halted and all of the surgical instruments used thus far, including the Bovie, are discarded and considered contaminated. All surgical gloves are changed. The 3M #1012 drape (Fig. #1, 2) is used to loosely drape the operative field. A small fenestration (Fig # 3) is made in the drape and blunt hooks (Fig. #4) are used to retract the cut edges of the drape.

Figure 1	Figure 2	Figure 3	Figure 4

Implantation of the device proceeds with the usual steps associated with a multi-component prosthesis, including the incision and dilation of the corpora; sizing and placement of the penile components; and placement of the pump in the scrotum and the reservoir in the retropubic space, all through the small fenestration in the #1012 drape. Injectable saline is used for irrigation in all cases. Once the corporotomies are closed and all of the tubing has been covered with a layer of Buck’s fascia, the drape is removed and the subcutaneous tissues and skin are closed.

The "No Touch" Technique for Inflatable Penile Prosthesis Implantation

Introduction

Inflatable penile prosthesis (IPP) is a well-established treatment for medically refractory erectile dysfunction. Infection 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.

Description

After making the scrotal incision, the procedure is halted and all of the surgical instruments used thus far, including the electrosurgical pencil are discarded and considered contaminated. All surgical gloves are changed. The 3M 1012 drape is used to loosely drape the operative field and a sterile Scott retractor is employed. A small fenestration is made in the drape and blunt hooks are used to attach the fenestration to the scrotal incision and retract the cut edges of the skin and drape. Implantation of the device is conducted with the usual steps including making corporotomies, dilating the corpora, placing the components including the reservoir in the retropubic space and the pump in the scrotum.

Materials and Methods

• N=1,927 IPP on virgin and revision patients between 2002 and 2010
• Both manufacture's 3-piece IPP were used – approximately 2:1 Coloplast Titan:AMS
• Patients were similar in age and comorbidilies
• In 2002, non-coated implants were used and the remaining years infection retardant coated IPP were implanted
• The last four years the “no touch” technique was performed
• Infection rates in the three groups were examined and subjected to statistical analysis

Results

	Implants	Infections	Infection %
Non-coated implants (2002)	132	7	5.3%
Coated implants (2003-2006)	720	13	1.8%
Coated implants plus "no touch" technique (2006-2010)	1075	8	0.7%

 

Conclusion
Infection retardant coatings lower risk of infection from 5.3% to 1.8%. The “no touch” enhancement to the surgical procedure results in additional improvement to 0.7%.

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Initial results of the “No-Touch Technique”

Patient Population

The records of 537 consecutive patients that underwent insertion of a multi-component penile prosthesis by a single surgeon using the “no-touch” technique over a two-year period were reviewed. Patients answered a pre-operative questionnaire regarding their medical and surgical history. Penile size and girth were the determining factors in deciding which prosthesis model (i.e., antibiotic-coated or not) were chosen for each patient. Patient data is displayed in Table 1.

Table 1.

Total Patients	537	Per cent
Virgin implant	491	91.4 %
Replacement	46	8.6%
Diabetic	230	42.8%
Antibiotic impregnated	208	38.3%
Non-antibiotic impregnated	329	61.7%
Infections	5	0.93%

Results

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. Data on the infected patients is presented in Table 2.

Table 2.

Patient	Diabetic	Virgin Implant	Antibiotic-coated prosthesis	Culture growth
SV	No	Yes	No	Coagulase Negative Staph.
ST	No	Yes	No	Coagulase Negative Staph.
JM	No	No	No	Coagulase Negative Staph.
JR	No	Yes	No	None
JF	No	Yes	No	None

Discussion

Reported infection rates for inflatable penile prostheses vary but are generally quoted to be between 1.8-10% for virgin prostheses and 7-21% for replacement prostheses. 2-4 Recent studies suggest that the use of antibiotic coated prostheses may lead to a reduction in the incidence of peri-prosthetic infection. 1,5 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.6 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 loose #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:

1. Carson, C.C., Efficacy of antibiotic impregnation of inflatable penile prosthesis in decreasing infection in original implants. J Urol 171: 1611, 2003.
2. Henry, G. D. et al. Revision washout decreases penile prosthesis infection in revision surgery: A multicenter study. J Urol 173: 89, 2005.
3. Lotan, Y., Roehrborn, C.G., McConnell, J.D., Hendin, B.N., Factors influencing the outcomes of penile prosthesis surgery at a teaching institution. Urol 62: 918, 2003.
4. Jarow, J.P., Risk factors for penile prosthetic infection. J Urol 156 (2): 402, 1996.
5. 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.
6. 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.