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Is Iatrogenic Implant Contamination Preventable Using a 16-Step No-Touch Protocol?
Abstract
Background. Intraoperative contamination of the surgical field during aesthetic breast augmentation may lead to implant infection with devastating consequences. This study covers a period of 30 years and is divided into 2 phases: a retrospective phase from 1992-2004 when a standard approach was used and a prospective phase from 2004-2022 when a no-touch approach was implemented to avoid contamination.
Methods. Patients in the standard and no-touch groups underwent aesthetic breast augmentation by the same senior surgeon (FDP) in the same outpatient surgical facility during the 30-year period of the study. Patients are divided into 2 groups: from 1992-2004 and from the implementation of the no-touch protocol in 2004-2022.
Results. Patients who underwent breast augmentation using the no-touch approach developed no infections, whereas the standard group had an infection rate of 3.54% (P = .017). The validity of this finding is discussed.
Conclusions. The no-touch approach as described in this article was effective in reducing implant infection rate when performing aesthetic breast augmentation by 1 surgeon at 1 surgical center during an 18-year observation period. Multicenter prospective cooperative studies are necessary to validate perioperative iatrogenic contamination as the cause of implant infection and to explore optimal approaches that could eliminate implant contamination.
Introduction
Surgery has been influenced during the past decade by progress made in the aviation industry, both of which involve teams of specialists working together in potentially life-threatening situations where even the most minor errors can lead to devastating consequences.1 Both of these fields have strived to improve globally accepted and understood safety measures to decrease morbidity and mortality.2 In healthcare, this influence has led to the development of intraoperative surgical safety checklists, among many other measures, to ensure optimal outcomes. However, like in aviation, complications are inevitable, and surgical complications including infections continue to burden patient care.3 Specifically in plastic surgery, breast augmentation is one of the most commonly performed cosmetic surgical procedures in the United States.4 Surgical site infections (SSI) can lead to poor patient outcomes, reconstruction failure, and even mortality.5 The SSI rate following implant-based breast reconstructions has been reported as approximately 2 to 29%.6,7 Contamination of the implant during surgery, skin or mammary duct flora, and the surgical environment can all contribute to infections.8 Minimizing or eliminating these contaminating sources is critical in lowering the likelihood of implant contamination and infection.
Implant sterilization, breast pocket irrigation, and antibiotic prophylaxis are a few infection prevention measures currently being utilized during breast augmentation procedures.9–12 These approaches are taken to reduce the incidence of implant infection and capsular contracture.13 However, the efficacy of these measures has not been scientifically established due to the lack of evidence-based data.5 In a recent survey among the American Society of Plastic Surgeons (ASPS), members suggested the need for best practice guidelines in areas such as breast pocket irrigation and implant soaking agents.14 The US Food and Drug Administration (FDA) banned the use of the soaking solution povidone-iodine in 2000 due to its potential degradative effect on silicone elastomer shells.9 They suggested using antimicrobial solutions containing antibacterial agents such as bacitracin, cefazolin, and gentamicin for infection prevention instead.10 However, with little evidence of the benefits of breast pocket irrigation and implant immersion with antibiotics, 10,11 the FDA revoked the ban against povidone-iodine use in 2017. Several studies showed that the povidone-iodine solution was effective in reducing capsular contracture due to its strong bactericidal activity against many strains of resistant organisms, including Methicillin-resistant Staphylococcus aureus, Vancomycin-resistant Enterococcus, and Mycobacterium.15,16
Besides minimizing contamination sources, incision sites also play a role in reducing infections, and several studies have reported that periareolar incisions lead to a higher rate of implant infection compared with inframammary crease incisions, likely due to colonization of breast ducts and parenchyma by bacteria.17–19 In addition, air circulation in operating room, contamination by other surgical team members, and improper glove changing practices may increase infection risk.20
The general concept of a no-touch ideology for infection prevention in surgery was first introduced by Sir William Arbuthnot Lane in 1894.21 One of the essential rules in this no-touch approach was that “a gloved finger should never come in contact with the wound.” In 1942, HAT Fairbank, the consulting surgeon of the Hospital for Sick Children in London, England, provided a detailed description of Arbuthnot’s no-touch principles and laid the foundation of modern surgical aseptic measures.21,22 Nevertheless, Fairbank’s recommendations are rarely followed in current practices, and as an example the same gloved fingers used during the operation routinely come into contact with the implants and the breast.
Several unexplained cases of implant infections during the early stages of this study prompted further reflection on Arbuthnot Lane’s original no-touch ideology. This inspired the implementation of the second phase of this study (2004 to present), which made certain additions to ensure contamination risk was further reduced (Figure 1 and Figure 2). This report aims to determine whether an evidence-based no-touch approach may effectively reduce implant infections compared with the standard approach used from 1992-2004 that resulted in an infection rate of 3.45%.
Methods and Materials
Patient Selection
Patients scheduled for aesthetic bilateral breast augmentation from 1992-2021 are included in this study. Participant inclusion criteria were diagnosis of breast hypoplasia with no previous history of breast surgery and medical clearance for surgery by a primary care physician. Exclusion criteria were women younger than 19 years and pregnant women or women with previous breast implant surgery. All smokers were asked to stop smoking for 2 weeks before and after surgery.23 All cases were performed by the same senior surgeon (FDP) in the same outpatient clinic. Patients were asked to return for follow-up for at least 6 months and were instructed to report any signs or symptoms of breast infection such as pain, redness, swelling, or fever. Chi-square test was used to compare patient demographics including age and race, and procedural variables including implant location, type, and procedure were performed. A Fishers exact test was used to compare implant infections, smoking, and diabetic history. An unpaired t test was used to compare mean surgical time, average age, and BMI from each group. All numbers referring to patients are rounded to whole values.
Implant Types
In the standard phase of the study (1992-2004), only smooth (Jones 1) or macrotextured (Jones 3) saline implants (McGhan/Allergan) were used due to the FDA’s ban of gel implants.24 During the no-touch prospective phase of the study, silicone gel–filled implants were approved by the FDA and were used from 2006 onwards. On May 2nd, 2019, the FDA also banned the usage of textured implants due to their link with anaplastic large cell lymphoma (BIA-ALCL).25,26 Variation in implant selection was due to changes in FDA approval and gold standard of practice.
Standard Group (1992-2004)
From 1992-2004, 198 primary breast augmentations or breast augmentations with mastopexy were performed. Smooth saline (Jones 1) implants were used in 17% of cases, while macrotextured (Jones 3) implants (McGhan/Allergan) were used in 83% of cases. The position of the implants was either subpectoral (80%), dual plane (13%), or prepectoral/subglandular (7%). Incisions were made within the areola in 79% of the cases, and 21% of the incisions were inframammary. Patients received 1 gm of cephalexin IV at the start of the operation and 1 500-mg cephalexin by mouth every 6 hours postoperatively for 7 days. This regimen follows national guidelines.
No-Touch Group (2004-2022)
During the 18-year period from 2004-2022, a total of 167 primary breast augmentation or breast augmentation with mastopexy procedures were performed implementing the steps described in Figure 1 and Figure 2. During the period of 2004-2006, 17% of patients received macrotextured saline implants (McGhan/Allergan), and after FDA approval in 2006, 74% of patients received macrotextured silicone gel implants. Implants were placed in subpectoral (77%), dual plane (13%), or subglandular (10%) locations through inframammary incisions. Half-strength povidone-iodine solution was utilized for pocket irrigation before implant insertion.9 Patients received 1 gm of cephalexin IV at the start of the operation and 1 500-mg cephalexin by mouth every 6 hours postoperatively for 7 days. This regimen follows national guidelines.
An anonymous questionnaire was mailed within 6 months post surgery to all patients. Anonymous questionnaires were also mailed to the 7 patients who developed infection (Table 1). They were asked to document their state of well-being after surgery and whether or not they would recommend breast implant to a friend in future. Their responses were quantified as shown in Table 1 and Table 2.
Results
A total of 365 patients underwent bilateral breast augmentation from 1992-2022. In the standard group of 198 patients, 7 implant infections (3.54%) were noted over a period of 12 years from 1992-2004, 6 breast augmentations alone and 1 with mastopexy. Despite receiving care from infectious disease consultants, none of these patients responded to systemic antibiotics, and explantation was required. Circumareolar incisions were used in 6 patients, and inframammary approach was used in 1 patient. However, this difference was not significant (P = .065). No significant differences were found either between the 2 groups with regard to demographic variables of patient ethnicity, smoking, history of diabetes (Table 3), age, implant type, location of the implants, and whether or not mastopexy was an added procedure (Table 4 and Table 5). However, BMI (P = .002) and operating time (P < .001) were both higher in the no-touch group of patients (Table 5). Since the implementation of the no-touch protocol in 2004 (Figure 1 and Figure 2), there have been zero reported cases of infections (P = .017) or Baker III/IV contractures (P = .065).
A total of 158 patients (48%) from both phases responded to an anonymous questionnaire. Responses addressing the patient’s state of well-being and whether or not they would recommend implant surgery to a friend were recorded and compared with responses received from all 7 patients who developed an infection. Patients who experienced infection reported a significantly lower well-being score compared with healthy patients. Infected patients were also significantly less likely to recommend implant surgery to others (P < .001; Table 1 and Table 2).
Discussion
Breast implants may easily become contaminated and colonized by bacteria during surgery. It has been shown that microorganisms are able to adhere to prosthetic surfaces in less than 2 minutes of exposure.27 Despite broad spectrum antibiotic use, studies reveal that in breast expanders and implants, infection rates have been reported from 2 to 29%.7 The importance of the addition of a no-touch approach is highlighted by the growing concern over the formation of bacterial biofilms, making effective use of perioperative antibiotic treatment difficult if not impossible.25,28–30 Breast implants are ideal foreign bodies for bacteria to adhere to because they have no vascularity and no defense mechanism to combat pathogens. Principle organisms commonly involved in readmission post breast implant infection reportedly include Staphylococcus epidermidis, Staphylococcus aureus, Escherichia, Pseudomonas, and Corynebacterium,31 in addition to a recent rise in mycobacterial infections.32–36 It has also been shown that despite proven antibiotic sensitivities, biofilm-producing bacteria such as Staphylococcus aureus and Staphylococcus epidermidis are able to resist the effects of antibiotics, making them nearly impossible to treat.37–39 Several infectious agents reported in this series (Table 6) are known to form biofilms that are highly resistant to a wide variety of antibiotic regimens.40,41 It has also been highly suspected that biofilms are a critical component in the development of high-grade capsular contractures (Baker III and IV) after breast augmentation with implants.42–44 A key component of the protocol in mitigating infection is the preoperative and intraoperative use of half-strength povidone-iodine, a highly effective bactericidal agent, that has also been recommended by Adams et al8 and others.37,45–48
Breast implant infections, both clinical and subclinical, continue to be a major problem that can lead to serious complications including explantation and capsular contracture.5,6 A total of 83% of patients in the standard group returned for follow-up within 6 months after surgery. Bilateral Baker III/IV contractures suggestive of subacute infection were present in 5 patients (1.6%).49,50 In the no-touch group, 80% of the patients were seen within the 6 months after surgery and none showed Baker III/IV contracture (Table 6). In this series of 7 infections in the standard group (1992-2004), none of the patients responded to the antibiotic regimen prescribed by the infectious disease consultants. The antibiotic regimen included intravenous antibiotics and hospitalization of 1 of the patients. Due to lack of clinical response, explantation with possible reimplantation at a later date was required.
Because there are no clear guidelines for treating implant infections,5,6,13,51 it is crucial to prevent initial contamination that may lead to infection. This ideology, advocated by Sir William Arbuthnot Lane in 1894 and later by others,17-20 was the basis of the no-touch phase of this longitudinal study that spans from 2004-2021. The standard approach (1992-2004) included preoperative examination of the patient without sterile gloves, insertion of fingers into the implant pocket throughout the operation for blunt dissection, use of the cautery for dissection, drain usage, use of the instruments without prior soaking in povidone-iodine solution, changing of gloves whereby the scrub nurse touches parts of the glove that will come into contact with the implant, and the use of circumareolar incisions (Figure 1 and Figure 2). The infection rate during the standard phase of the study was 3.45%, which is consistent with other reported studies.6,31,38,52
This study shows that implant infection not only ruins the outcome of an otherwise uneventful aesthetic operation but also significantly impacts patient well-being and opinion of the breast implants. A high proportion of patients who developed infection reported they would not recommend implant surgery to friends (Table 2). This was in significant contrast with patients who did not develop infection (P < .001).
The no-touch protocol requires diligent attention to each step described in Figure 1 and Figure 2. As such, the operating time was prolonged by approximately 13 minutes compared with the standard group. BMI was also significantly higher in the no-touch group (Table 5). Both prolonged surgical time and higher BMI are well known to increase the incidence of infections.53,54 In addition, the majority of implants used were macrotextured (Table 4), which has also been reported to have a higher risk of infection.55 Despite these findings, successful mitigation of infection was still seen in the no-touch group (P = .017).
Adams’ 14-point guideline that was reported in 2017,8 13 years after the beginning of this study, provides useful evidence-based suggestions that are implemented in this protocol, including careful hemostasis and the use of betadine irrigation. Some of the noteworthy differences in this study’s approach include sterile preoperative markings of the breasts, no drain use, and a defined period of hemostasis pause. In concert with Adams et al,4 the use of an inframammary crease incision rather than in the areola; routine irrigation of the implant pocket with half-strength povidone-iodine solution prior to implant insertion; and changing of gloves, albeit with some modification, are recommended (Figure 2). In this approach only the glove cuff is touched by the scrub nurse. This concept of glove-changing before handling an implant or any other foreign body in surgery is supported by similar studies that follow no-touch methods, including a reversed glove sleeve method implemented in 2020 by Barker et al.8,47,56–58
In addition to the listed differences with Adams’ approach, this study also used a minimum 5-minute pause to double-check for hemostasis before inserting the implants. Because electrocautery results in charring of healthy tissues that leads to hypovascularity and tissue necrosis, creating a favorable culture environment for bacterial growth, only precise pinpoint cauterization should be used.59–61
Also, the use of absorbable monofilament sutures such as poliglecaprone for intradermal closure of the wounds is recommended. These sutures along with other similar absorbable monofilament sutures have been shown to have very little tissue reaction and have been reported not to increase the risk of wound infection, especially when compared with vicryl and commonly used other braided sutures that are known to promote bacterial colonisation and infection.62
Like in the aviation industry, attaining virtually no complications seem idealistic at the present time. Many extraneous factors have been shown to potentially lead to infection, including mishandling of sterile boxes or reusable draping material resulting in iatrogenic contamination or poorly circulating air in the operating room.63–65 Only a few reports detail the possibility of zero surgical site infections.66,67 Specifically, in breast reconstruction, a recent study by Papa et al67 reported a drop to a 0% SSI rate after the introduction of a prevention protocol in June 2020.In conjunction with the present study, this report demonstrates that improvement is still possible and needed in this field. Thus, a relentless effort must remain to optimize methods to minimize infection rates and improve patient outcomes. By using an evidence-based approach, zero infections were reported over 18-year period in one surgical center with a 167-patient sample. The no-touch protocol steps (Figure 1 and Figure 2) need further investigation and prospective multicenter clinical trials by other surgeons in the future. Therefore, further studies are encouraged to determine whether this approach or modifications of this approach are effective in reducing infection rate.
Limitations
Limitations to this study include the relatively limited sample size of 167 patients. In addition, this protocol was only followed at 1 surgery center by 1 surgeon. Also, the longevity of this study reflects a time period when variations in implant type were considered gold standard of care, and as such, the patients within each group may have received a different type of implant that could influence infection rate and the results. Finally, unintentional contamination of the implants, gloves, or any surgical instrument prior to surgery may result in infection.
Conclusions
This limited study reports on the effectiveness of a no-touch approach in aesthetic breast augmentation in 167 patients from 1 center by 1 surgeon over an 18-year period and cannot be generalized. Due to the abundance of variables and factors that may contribute to implant contamination and infection, further prospective multicenter studies are necessary to support the findings of this report. Compared with the standard approach by the same surgeon in the same facility, the proposed no-touch approach (Figures 1 and 2) significantly reduced infections (P = .017) and Baker III/IV contractures (P = .065).
Acknowledgments
Affiliations: 1University of Hawaii, John A Burns School of Medicine, Honolulu, HI; 2University of Southern California, Los Angeles, CA; 3Plastic Surgery Division, Department of Surgery, University of Hawaii, John A Burns School of Medicine. Honolulu, HI
Correspondence: Fereydoun Don Parsa, MD; fdparsa@gmail.com
The first two authors contributed equally to this work.
Funding: This work was supported by the Naval Medical Research and Development Command, work unit 61153N MR04120.001-1002.22.
Ethics: Institutional review board approval was obtained before the study was conducted. This study was approved as a performance improvement project and conducted in accordance with Declaration of Helsinki.
Disclosures: The authors have no relevant financial or nonfinancial interests to disclose.
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