Penile Implant: Review of a “No-Touch” Surgical Technique
There are more than 725,000 cases of nosocomial infection in the United States each year, over 25% of which are implant device-related.1 Of these, the most difficult to manage tend to be infections associated with surgical implants, as follow-up typically requires lengthy courses of antibiotics, as well as repeated surgical procedures.2 Such infections occur across a number of medical specialties, including neurosurgical, orthopedic, plastic, and urologic surgery, and can have serious clinical consequences. For example, infections associated with ventricular shunts or fracture-fixation devices can result in serious disability, whereas infections associated with mammary or penile implants can cause significant disfigurement and psychological trauma. These types of infections also can have considerable economic consequences related to the costs of device removal and replacement, regardless of the type of implant.3
Because infections associated with surgical implants can be difficult and costly to manage, as well as devastating to the patient, prevention is critical. Typical strategies include pre- and postoperative systemic antibiotic administration, topical application of antibiotics and/or antiseptics, irrigation of the surgical field with antimicrobial or saline solution, and use of antibiotic-coated penile implant devices. Even with such strategies, infection rates remain unacceptably high. For example, postoperative infection has been reported in 4% and 18% of primary and revised penile implant cases, respectively,4 1% to 6% of prosthetic breast implant cases,5 and 8% to 10% of cerebrospinal fluid shunt operations.6
This paper will review the use of a relatively novel “no-touch” technique found to reduce the risk of postoperative infection following surgery for orthopedic fracture, cerebrospinal fluid shunt placement, breast reconstruction/augmentation, and penile prosthesis implantation. It will focus primarily on the latter application.
Early Use of the “No-Touch” Technique During Orthopedic Surgery
In the 1890s, Sir William Arbuthnot Lane developed a “no-touch” surgical technique as part of his effort to maintain a more aseptic environment during open reduction of orthopedic fracture using screws, wires, and steel plates.7, 8 and 9 The technique involved the use of thick gauze to cover the patient's skin and wound edges, as well as long-handled instruments that increased the distance between the surgeon's hands and the open incision. Additionally, the knife used to make the initial skin incision was discarded and a new knife was used in the wound, and Lane's operating room assistants used forceps to pass instruments to him and thread needles for suturing.
Use of the “No-Touch” Technique During Neurosurgery
Ashpole acknowledged the benefit of using a “no-touch” technique when implanting ventricular shunts, but noted that it was difficult to accomplish due to the “small and slippery” shunt components.10 He therefore designed a set of instruments that could be used to handle and assemble shunt systems without touching them. The instruments included a block to hold the valve, as well as several different types of forceps, each for specific tasks. In addition to reducing the risk of infection, he pointed out that the technique decreased the risk of damaging the shunt-related devices and catheters, although no data were provided for either endpoint.
Faillace avoided some of challenges noted by Ashpole by using a 1-piece shunt that did not require assembly, thus circumventing the need for special instruments.11 His “no-touch” approach attempted to avoid bacterial contamination by taking extreme care not to touch the skin incision edges and shunt components during the implantation procedure. Instead, only instruments were used to handle the shunt and shunt sutures, and those instruments were kept separate from the instruments used to dissect the skin and soft tissue. When compared with his previous surgical protocol, the “no-touch” technique decreased the postoperative shunt infection rate from 9.1% (based on 120 surgeries) to 2.9% (based on 67 surgeries), reflecting a clinically significant improvement. Table 1 describes the differences in the 2 protocols.
Although a more recent study of ventricular shunt infection by Kanev and Sheehan did not cite Faillace's work, it noted several features that distinguish their “no-touch” technique during shunt placement.6 These included (1) using Michelle clips to secure bacitracin-soaked gauze to the edges of the skin incisions to minimize contact between instruments or fingers and the incision edges; (2) handling shunt components only with latex-free silastic-tipped forceps, to decrease mechanical injury to shunt tubing, thereby limiting potential sites for bacterial adherence; and (3) assuring that the instruments used to place the shunt never come into contact with skin edges. The authors reported that their infection rate was limited to 1.33% during a 62-month period when they placed or revised 526 shunts.
Use of the “No-Touch” Technique During Plastic Surgery
Use of a “no-touch” technique has also been reported by several different plastic surgeons for breast augmentation or reconstruction procedures. For example, Mladick used a “no-touch” technique for 557 saline implants during a period from 1987 to 1992.12 He described it as a “superiorly sterile technique that eliminates any possible source of bacterial contamination,” although he acknowledged that the technique described by Fairbank was more strictly sterile. The objective of Mladick's technique was to avoid contact between the implant and the patient's skin, as well as to minimize contact with the breast tissue. For example, to insert a drain without touching skin or breast tissue, the surgeon grasps a long trocar with a sterile sponge instead of a gloved hand, while an assistant uses a hemostat instead of a gloved hand to hold the drain. Then, to insert the implant, the surgeon wears a new pair of gloves that have never touched the patient, and retractors are placed by the assistant to ensure that the implant is inserted in a manner that avoids contact with the skin and breast tissue. Or, if the size of the incision is so small that contact between the implant and tissue cannot be avoided, a sterile sleeve is placed over the implant.
Mladick retrospectively compared complications during 2 periods, from 1980 to 1986 (ie, prior to using the “no-touch” technique) and from 1987 to 1992 (ie, while using the “no-touch” technique); however, he noted that the study included a number of uncontrolled variables and only modest follow-up. There were no infections during either period. Mladick reported significantly less wrinkling (visible folds), deflations, and capsular contracture during the second period, and attributed the latter at least in part to the theory that the “no-touch” technique may help decrease the rate of subclinical staph epidermidis contamination, which is a significant cause of contracture.
More recently, Moyer et al studied the use of the Keller Funnel, a device developed to permit “no-touch” insertion of a breast implant.5 By painting the thorax of cadavers with fluorescein dye prior to implantation and then measuring fluorescein emission from the implant following insertion, the investigators determined that use of the funnel permitted a 27-fold decrease in skin contact when compared with a digital implantation technique (P = .00059). By swabbing the cadaver breast tissue with methicillin-sensitive Staphylococcus aureus and then culturing the implant surfaces following implantation, the investigators also determined that use of the funnel decreased bacterial contamination from breast parenchyma to less than half the contamination rate observed with the digital implantation technique; however, this finding approached, but did not reach, statistical significance (P = .06).
Instead of using a funnel, Zhang and Blanchet modified a Devon Lite Glove (a light handle cover; see Figure 1) by cutting off the closed end of the glove, thus converting it to a sleeve with a narrow end that could be placed into the small inframammary incision.13 A folded, deflated saline prosthesis then could be introduced into the lubricated sleeve and implanted without skin contact. The authors report using the technique in a series of 64 patients with no incidence of capsular contracture; however, they note that the sleeve works only with saline implants and not with gel implants.
Wilson studied the use of a “no-touch” technique during immediate, expander-based, post-mastectomy breast reconstruction which, compared with breast augmentation, involves a surgical field that is less controlled and more contaminated.14 During the “no-touch” procedure, instruments used for the preliminary surgical steps (eg, the electrocautery apparatus, light handles, and suction tools) were removed from the field, so that the implant was not contaminated by instruments that have touched the skin. The “no-touch” procedure also involved placement of a sterile transparent drape that completely covers the exposed skin and is stapled to edges of the wound to hold it in place, around which a second set of surgical drapes are placed. A self-retaining retractor is then placed in a slit made in the transparent drape between the mastectomy skin edges. The retractor includes hooks that simultaneously retract the skin edge and gather the transparent drape, so that it wraps inward and completely covers the cut edge of the skin, ensuring that neither the graft nor the implant can become contaminated by the skin. Prior to using the “no-touch” technique, the rate of post-operative surgical site infection or seroma during a series of 16 breast reconstructions was 19%, compared with no postoperative surgical site infections or seromas during a series of 25 breast reconstructions using the “no-touch” technique (P = .025).
Use of the “No-Touch” Technique During Urologic Surgery
The use of a “no-touch” surgical procedure was pioneered for implantation of an inflatable penile prosthesis to treat erectile dysfunction, which incorporates aspects of several of the techniques described above.15 and 16 The surgery begins traditionally: first, the surgeon delivers the penis and scrotum through a small hole in an iodophor-impregnated drape and makes an incision in the penoscrotal raphe, with dissection carried down through the subcutaneous tissue and dartos to the level of Buck's fascia. Five yellow hooks are then utilized to secure and retract the edges of the skin and held with a Scott retractor (Figure 2).
At that point, all surgical instruments are considered contaminated and are removed from the surgical field, and everyone who has touched the patient's skin replaces their surgical gloves. A 3M #1012 drape (3M, St. Paul, MN, USA) is then brought onto the surgical field loosely placed over the penis, scrotum, and surrounding surgical field, and secured with its adhesive edges (Figure 3).
Over the retracted incision, the surgeon makes a small fenestration in the 3M drape (Figure 4). An additional 4 blunt hooks are used to simultaneously retract the edges of the opening of the 3M drape and the edges of the skin incision and are then secured to the retractor.
The surgeon then performs the remainder of the penile implant procedure through the opening in the drape, thus eliminating all direct and indirect contact between the patient's skin and the surgeon's hands, the surgical instruments, and the penile implant. The corporotomies are closed with a 3-0 PDS- RB1 suture in a running fashion and 4 cc of a hemostatic matrix (Surgiflo, Ethicon, Somerville, NJ, USA) is injected into each corpus before the suture is ligated. Once the penile prosthesis is implanted, a layer of tissue is closed entirely, covering all of the implanted components, and then the drape is removed and the subcutaneous tissue and skin are closed. No drains are utilized and patients are discharged to home the same day. The “no-touch” enhancement added on average 10 minutes to the procedure and the average total operating time was 1 hour, 15 minutes. Implantation of all devices, including removal and replacements were conducted in an identical fashion through the fenestration of the 3M drape and all surgeries were performed as mentioned and documented in the pictures.
This review is from a single surgeon's experience in 3 private ambulatory surgery centers. A single surgeon, the author, performed all penile implants through the standardized penoscrotal approach. Also, since 2002 every case performed was logged into a database and tracked in a prospective fashion. Patients were examined or contacted at 2, 4, and 12-week, and then 6 and 12-month intervals.
A total of 3342 penile prostheses were implanted between January 2002 and December 2014 as summarized in Tables 2 and 3. The data are divided into 3 distinct periods: (1) during 2002, the penile prostheses used were neither coated with infection retardant nor implanted using the “no-touch” technique (n = 132); (2) from 2003 through 2005, the penile prostheses used were coated with infection retardant, but the “no-touch” technique was not used (n = 704); and (3) from 2006 through 2014, the penile prostheses used were both coated with infection retardant and implanted using the “no-touch” technique (n = 2506).
Type and Brand of Penile Implants
Of the total 3342 penile implantations performed over a 13-year period, 132 (85 American Medical Systems [AMS, Minnetonka, MN, USA] and 47 Coloplast [Coloplast, Minneapolis, MN, USA]) were noncoated in 2002; there were 701 coated implantations (250 AMS,454 Coloplast) from 2003 to 2005; and a total of 2506 penile implantations (626 AMS, 1880 Coloplast) performed using the “no-touch” enhancement over the next 9 years starting in 2006. Primary penile implants accounted for 2038 cases, whereas 468 were implant removals and replacements. Since 2002, the AMS 700CX and LGX accounted for 959 cases, AMS Ambicor devices, 2 cases; 2335 cases used Coloplast Titan penile implant devices and 46 cases used Coloplast Genesis semi-malleable devices. The Genesis was used for cases with severe fibrosis in which corporal dilation to 13mm was not possible, and 43 were later converted to an inflatable penile device after a 3-month period.
Of the 132 patients implanted during 2002, 7 developed infections, reflecting an infection rate of 5.30%. Cultures of the infected patients grew coagulase-negative Staphylococcus (n = 3), Enterococcus faecalis (n = 1), or had no growth (n = 2). Of the 704 patients implanted from 2003 to 2005, 14 developed infections, reflecting an infection rate of 1.99%. Cultures of the infected patients grew coagulase-negative Staphylococcus (n = 3), Staphylococcus aureus (n = 1), Enterococcus faecalis (n = 1), or had no growth (n = 10). Of the 2506 patients implanted from 2006 to 2014, 11 developed infections, reflecting an infection rate of 0.44%. Cultures of the infected patients grew coagulase- negative Staphylococcus (n = 3), Enterococcus faecalis and Candida (n = 1), Escherichia coli (n = 2), Lactobacillus acidophilus (n = 1), and Enterococcus faecalis (n = 1), or had no growth (n = 3). The total infection rate significantly decreased between the first 2 periods (P = .0350) and between the first and third period (P < .0001), as well as between the second and third period (P = .0002).
The use of a “no-touch” technique during surgeries as varied as orthopedic fracture repair, cerebrospinal fluid shunt placement, breast reconstruction/augmentation, and penile prosthesis implantation highlights a common concern about contamination of implanted devices by skin flora. Although modification of a device surface to inhibit bacterial presence in the biofilm (ie, with an microbial coating or other type of infection retardant) is one of the most commonly used methods of preventing device-related infection, its success appears to depend on variables such as device location, type of infecting pathogens, and coating agents used.2 However, improvements in the incidence of infections caused by the use of these coated devices is further evidence that bacterial contamination occurs during implantation and provides an incentive to develop a surgical technique which completely isolates the skin from the device. The first publication on the use of the “no-touch” technique for penile prosthesis surgery was published by the author in 2012 to explore whether a “no-touch” enhancement to the penoscrotal surgical approach further reduced infections beyond the use of coated implants.15 In the case of inflatable penile prosthetic implantation, augmenting the use of a coated device with a “no-touch” technique appeared initially to further reduce infection rates from 1.8% to 0.46%.15 The current review aims to examine whether this low infection rate could be sustained for a larger number of implant procedures. For the next 4 years the total number of implanted patients increased from 1511 to 2506 and the infection rate remained at 0.44%. In addition a review of the literature on the use of the “no-touch” technique in other types of surgeries was made to further support its use for penile prosthesis implantation. Indeed, similar results have been reported in the fields of orthopedic surgery, neurosurgery, and plastic surgery; however, many of those studies were published more than a decade ago.6 and 8
Prior to the use of infection retardant coating, skin flora (eg, S epidermidis) appeared to be responsible for approximately 65% to 75% of infected urologic devices. 17 and 18 Subsequent research suggested that the introduction of infection retardant coating primarily targets these organisms, but not infections caused by Enterococcus, S aureus, E. coli, and Pseudomonas. 19 Indeed, the data in Table 3 reflect an increase in some of these less common, albeit more aggressive, skin pathogens during the periods when patients were implanted with devices coated with infection retardant. It was logical, therefore, to explore the use of a skin barrier to attempt a further reduction of infections. Although the iodophor-impregnated drape has been shown to be effective and is used in our technique, it is not used as a skin barrier. Because the iodophor-impregnated drape has an adhesive backing to it, it restricts the necessary intraoperative manipulation of the penile shaft and scrotum. With the loose surgical drape used in the “no-touch” enhancement, the barrier function is preserved, while allowing mobility of the penis and scrotum. This mobility is essential to manipulate and examine the shaft of the penis flaccid and erect after cylinder insertion as well as to inflate and deflate the scrotal pump inside the penis. Because the tissue spaces for the components are fashioned without contact with the patient's skin, contamination of the intra-cavernosal, scrotal, and space of Retzius is thought to be minimal. Also, because the components of the penile implant devices are prepped and implanted by gloved hands that have never touched the patient's skin; the contamination of the implant with organisms from the patient's skin is thought to be negligible. Lastly, another unrecognized benefit of the “no-touch” technique is that it allows for intraoperative repositioning and/or length adjustment of the cylinders with minimal exposure to skin flora. A drawback of the “no-touch” enhancement is that it increases the cost of the operation to a mild degree by requiring duplication of some instruments and supplies, and increases the operative time by approximately 10 minutes. When compared with the pain and suffering as well as the substantial cost of a penile implant infection in both real money and emotional distress on the patients, these increases appear to be trivial. Although data to date strongly suggest that the use of a “no-touch” technique involving a mechanical barrier makes a difference in preventing infection of an implantable device, it does not unequivocally prove this hypothesis. For example, other variables, such as improved surgical technique over time, could potentially explain the decrease in infections, regardless of the use of the “no-touch” technique. A study in which patients are randomized to receive an implanted device using either a “no-touch” technique or a more traditional surgical technique could help further elucidate this issue; however, it would not be possible to blind the surgeon to the procedure used. Nevertheless, our 9-year experience with the “no-touch” enhancement in 2506 consecutive penile implant procedures has achieved an unprecedented low infection rate of 0.44%. This is currently the lowest infection rate reported in the literature.
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Conflict of interest: Dr Eid receives or has received research support/grants from American Medical Systems (AMS), Coloplast Corporation, Lilly ICOS LLC, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer Inc. He is or was a consultant and on the speakers bureau for Coloplast, AMS, Lilly ICOS LLC, Bayer, and Pfizer In.