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Antibiotic Prophylaxis following Implant-Based Breast Reconstruction: What Is the Evidence?

Phillips, Brett T. M.D., M.B.A.; Halvorson, Eric G. M.D.

Plastic and Reconstructive Surgery: October 2016 - Volume 138 - Issue 4 - p 751-757
doi: 10.1097/PRS.0000000000002530
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Background: Although data from other surgical disciplines do not support the use of prolonged postoperative prophylactic antibiotics, implant-based breast reconstruction is one area of plastic surgery where this may be warranted. The purpose of this study was to review the literature on antibiotic prophylaxis in prosthetic breast reconstruction, summarize findings, and provide recommendations.

Methods: A literature review was performed to identify studies that compared different perioperative prophylactic antibiotic regimens with respect to infectious outcomes in prosthetic breast reconstruction.

Results: Five studies and five systematic reviews were identified. One prospective randomized trial showed that a single preoperative dose was better than placebo, and another showed no difference between 24 hours versus until drain removal. Three studies were retrospective, one showing no difference between a single preoperative dose and prolonged antibiotic use, and two showing significant reduction in infectious complications with prolonged antibiotic use. One systematic review suggested an increased rate of infection with prolonged antibiotic use, and the other showed no difference between less than 24 hours and greater than 24 hours, but showed a reduction in infections compared to no treatment.

Conclusions: The literature contains conflicting data regarding the optimal duration for perioperative antibiotic prophylaxis following prosthetic breast reconstruction. The authors’ opinion is that 24 hours of antibiotic prophylaxis is warranted. Further studies are needed. Patient-centered antibiotic prophylaxis based on a risk-assessment model may be a more effective alternative to the current indiscriminate model of surgical-site infection control.

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Durham, N.C.; and Boston, Mass.

From the Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Medical Center; and the Division of Plastic Surgery, Brigham & Women’s Hospital, Harvard Medical School.

Received for publication November 4, 2015; accepted May 10, 2016.

Disclosure:The authors have no financial disclosures.

Eric G. Halvorson, M.D., Division of Plastic Surgery, Brigham & Women’s Hospital, 75 Francis Street, Boston, Mass. 02115, ehalvorson@partners.org

Plastic surgeons are certainly known for their liberal use of postoperative prophylactic antibiotics.1–6 It is not uncommon for plastic surgeons to prescribe an extended course of antibiotics following minor procedures in healthy patients. Despite the ubiquity of evidence-based medicine and many studies on antibiotic prophylaxis in the surgical literature, the use of prophylactic antibiotics in plastic surgery remains largely based on anecdotal evidence and historical convention. Plastic surgeons often justify this practice by claiming that their operations are somehow different from those in other specialties. Wide undermining, compromised perfusion, placement of implants, cosmetic patient expectations, and prolonged drain use are commonly cited reasons for extended postoperative prophylactic antibiotic use.7

Although the plastic surgery literature does not offer much on postoperative prophylactic antibiotics, there is an abundance of evidence in other surgical disciplines that would suggest that the majority of plastic surgery procedures do not warrant use of postoperative prophylactic antibiotics beyond 24 hours.8–14 Although some Surgical Care Improvement Project guidelines were retired as of January of 2015 (INF-2 and INF-3), duration and selection of antibiotic prophylaxis continues to be an important topic for The Joint Commission.15 The new Joint Commission measurement system, ORYX, integrates performance and outcomes into a more flexible system for hospital accreditation.16 Proper antibiotic administration is still essential for providing appropriate treatment of our patients and preventing unnecessary cost and side effects.

Although it is hard to argue that a patient requires any antibiotics following a benign skin lesion excision, placing a large foreign body under compromised skin flaps is a clinical scenario that is not well addressed by the literature of other surgical specialties. As such, prosthetic breast reconstruction is likely the most common procedure in plastic surgery where postoperative prophylactic antibiotics may be warranted. However, important questions remain: Is there evidence that prolonged postoperative prophylactic antibiotic use reduces the risk of infections in these patients? How long should patients be on antibiotics after surgery? Twenty-four hours? One week? Until the drains are removed? In this article, the evidence for postoperative prophylactic antibiotics in prosthetic breast reconstruction is reviewed.

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METHODS

Search Methodology

A literature review was performed to identify studies that compared different perioperative prophylactic antibiotic regimens with respect to infectious outcomes in prosthetic breast reconstruction. The PubMed and Cochrane databases were queried. Key words used were “antibiotics,” “antibiotic prophylaxis,” “breast reconstruction,” and “implant breast reconstruction” in various combinations. In addition, we also used an established systematic review search previously performed by one of the authors (B.T.P.) using Medical Subject Headings terms [“Mammaplasty” (Medical Subject Headings) AND “Anti-Bacterial Agents” (Medical Subject Headings)], [Breast reconstruction AND “Anti-Bacterial Agents” (Medical Subject Headings)], [“Mammaplasty” (Medical Subject Headings) AND antibiotics], [“Anti-Bacterial Agents” (Medical Subject Headings) AND breast reconstruction AND “Infection” (Medical Subject Headings)], (breast reconstruction AND antibiotics), [“Infection” (Medical Subject Headings) AND breast reconstruction], and [“Infection” (Medical Subject Headings) AND breast reconstruction].17

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Selection Criteria

Inclusion and exclusion criteria were established before the literature review. Retrospective and prospective studies were included if they reported antibiotic regimens and associated infection rates in implant-based breast reconstruction. Studies that involved autologous breast reconstruction were excluded. For each study, the study design (i.e., retrospective, prospective, or review), reconstruction type (i.e., expander, implant, or flap), reconstruction timing (i.e., immediate, delayed, first-stage, or second-stage), acellular dermal matrix use, antibiotic regimens, number of patients, number of infections, infection rate, and level of evidence were noted.

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RESULTS

A total of seven articles were identified that met our inclusion criteria (Tables 1 and 2).17,18–23 Five were clinical studies and two were systematic reviews, all published between 1995 and 2014. The clinical studies consisted of two prospective randomized trials and three retrospective studies. Only one study did not include the use of acellular dermal matrix. Several different antibiotic regimens were identified and included a range of no antibiotics to antibiotics until drain removal. Infection rate results also displayed a broad range extending from 0 to 50 percent. Reconstructive types also included the full spectrum of operations, including immediate and delayed timing; first- and second-stage breast reconstruction; and implant-based, tissue expander-based, and autologous flap reconstruction.

Table 1.

Table 1.

Table 2.

Table 2.

The first randomized trial compared a single preoperative dose of antibiotic to placebo and found a decreased infection rate with a single dose. The second randomized trial compared 24 hours of antibiotics versus antibiotics until drain removal in immediate tissue expander-based breast reconstruction. This study found similar infection rates in the two groups, but a tendency to develop more severe infections in the prolonged antibiotic group. Three studies were retrospective, one showing no difference between a single preoperative dose and prolonged postoperative antibiotics, and the other two showing significant reduction in infectious complications when prolonged postoperative antibiotics were used. Two systematic reviews were identified, one showing an increased rate of infection with prolonged postoperative antibiotics, and the other showing no difference between less than 24 hours and greater than 24 hours of antibiotics, but a reduction in infections compared to no antibiotic use. The systematic reviews did not have mutually exclusive articles because the topics were very similar. Only one of the articles presented in the table (Amland et al.19) was already included in one of the systematic reviews (Phillips et al.17).

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DISCUSSION

Studies on Antibiotic Prophylaxis in Autologous Breast Reconstruction

The aim of this study was to review the literature on antibiotic prophylaxis in implant-based breast reconstruction; however, autologous breast reconstruction is also burdened with complication rates as high as 60 percent.24 Infection rates have been reported to be as high as 27 percent, although the literature generally supports an average infection rate of less than 5 percent.17,18,25 Several retrospective studies have shown that antibiotic duration does not change the postoperative infection rate in autologous breast reconstruction. Drury et al. performed a retrospective analysis of the Tracking Operations and Outcomes for Plastic Surgeons database to examine 30-day infection rates in 1063 patients that received less than 24 hours of antibiotics or more than 24 hours of antibiotics.26 Two-thirds of patients received the former regimen, and one-third received the later. The overall infection rates were 5.02 percent versus 2.92 percent (p = 0.109) and were not found to be statistically significant. Liu et al. conducted another retrospective study that compared 256 autologous breast reconstruction patients at a single institution.27 This study compared the same antibiotic durations as the previous study and also found no statistically significant difference in infection rates between the two groups (19.5 percent versus 15.5 percent; p = 0.47). The median duration of postoperative antibiotic use in the prolonged group was 10 days. Although both of these studies have similar conclusions, they suffer from similar limitations that are inherent in retrospective studies.

Based on these studies, the lack of compromised tissue or an implant, and evidence from other surgical fields, the authors do not recommend postoperative prophylactic antibiotic use following autologous breast reconstruction, even when mesh is used for fascial reinforcement. The authors recommend 24 hours of intravenous antibiotics in accordance with Surgical Care Improvement Project guidelines for autologous breast reconstruction procedures. Hybrid procedures, where both a flap and implant are used, is an area that is not addressed well by the literature, and should be the subject of future study.

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Studies on Antibiotic Prophylaxis in Prosthetic Breast Reconstruction

Amland et al. performed the first prospective, double-blind, placebo-controlled, randomized clinical trial on antibiotic use in plastic surgery in 1995.19 This study examined a broad range of consecutive cases that were randomized to a single preoperative dose of azithromycin or placebo. Although only a small population included breast reconstruction (17.8 percent), they found a significant reduction in postoperative infection with the use of single preoperative dose. Fifty-six reconstructive cases included flaps and implants, with only 28.6 percent of patients undergoing implant reconstruction. In these 16 patients, only six patients received preoperative antibiotics, with no postoperative infections. The placebo group included 10 patients with a 20 percent infection rate. No significant difference was identified in antibiotic-related complications such as gastrointestinal tract upset or skin rash.

Clayton et al. examined infectious outcomes in breast reconstruction following an antibiotic regimen change to accommodate Surgical Care Improvement Project recommendations.18 This retrospective study included a heterogeneous mix of 250 breast reconstruction cases that were examined as two different mixed cohorts. The first cohort of 134 patients received antibiotics until drains were removed, and the second cohort of 116 patients received only a single preoperative dose of antibiotics. Infection was defined broadly and divided into three groups: (1) infections resolving with oral outpatient antibiotics, (2) infections resolving with inpatient intravenous antibiotics, and (3) infections requiring surgery. When looking at all patients and various reconstructions, the preoperative antibiotic group had an overall infection rate of 34.3 percent compared to the control group with 18.1 percent (p = 0.004). After multivariate logistic regression, the entire preoperative group was 4.74 times more likely to require a reoperation (p = 0.004) because of infection, whereas tissue-expander patients in the preoperative group had an odds ratio of 3.77 (p = 0.033). This study once again points to the fact that breast reconstruction does not follow the standard surgical-site infection rates of other clean elective surgery. With infection rates as high as 34 percent seen in this study, the authors concluded that a single preoperative dose is likely not sufficient for postoperative prophylaxis in prosthetic breast reconstruction.

Avashia et al. also performed a retrospective study that looked at a change in antibiotic regimen for acellular dermal matrix–assisted tissue expander breast reconstruction.20 This single-surgeon study of immediate and delayed reconstructions compared patients in three cohorts. The first and third cohorts combined 72 patients who received more than 48 hours of postoperative antibiotics with an intermediate group of 12 patients who received less than 24 hours of antibiotics. The group of 12 patients was a result of the change in antibiotic protocol and spanned a period of 1½ months. Because of an infection rate of 50 percent, the surgeon returned to his previous antibiotic regimen. The resulting infection rate in the 19 patients that followed in the third cohort was only 5.3 percent. The authors concluded that the optimal antibiotic regimen is at least 48 hours of antibiotic use after tissue expander breast reconstruction with acellular dermal matrix. This study unfortunately has several limitations that include its retrospective nature and small sample size. The conclusions are based on a sample of 12 patients over a short period with a quick reversion to previous practices. In addition, the cohorts were defined based on atypical and poorly defined antibiotic regimens (<24 hours or >48 hours). In most studies and clinical practices, patients receive postoperative antibiotics until 7 days postoperatively or until drains are removed.7 As seen in the previous study by Clayton et al., a single preoperative dose of antibiotics appears to be insufficient compared to 24 hours or longer.18,21

A systematic review of antibiotic regimens and infection rates for all types of breast reconstruction was by performed by Phillips et al. in 2013.17 This study examined the associated infection rates with specific antibiotic durations in 81 studies with almost 15,000 patients over 31 years. After an initial 10 categories of antibiotic duration were identified, the authors recategorized them into three categories based around a time point of 24 hours. The overall average infection rates were 14.44, 5.76, and 5.78 percent in the no-antibiotics group, less than or equal to 24 hours of antibiotic use, and more than 24 hours of antibiotic use, respectively. When examining specific types of breast reconstruction, the infection rates were 5.78, 3.20, and 5.20 percent in implant, autologous flap, and autologous flap with implant reconstruction, respectively. Unfortunately, a complete meta-analysis was not possible in this study because of variability in outcome reporting of antibiotic regimens, infection, and reconstruction types. The authors did offer new guidelines and standardized definitions for improved documentation that includes surgical-site infection grading.

A similar systematic review was conducted looking at the same factors but only with acellular dermal matrix breast reconstruction.22 This study examined 24 studies with a combined 2148 patients over an 8-year period. The overall infection rate was 11.59 percent. Studies were placed into four different antibiotic durations and then further combined to form groups of less than or equal to 24 hours and more than 24 hours. Surprisingly, the infection rates were 2.48 percent and 13.21 percent in these groups, respectively. Several of the studies were comparative in nature and reported both acellular dermal matrix and non–acellular dermal matrix patients. The overall infection rate in the non–acellular dermal matrix patients was 4.74 percent, which was just more than half that of the acellular dermal matrix counterparts in this review. Although this review found higher infection rates in acellular dermal matrix patients, the discussion remains controversial, with many individual studies suggesting no difference. The purpose of this study resulted in the exclusion of many acellular dermal matrix studies that did not report their respective antibiotic regimens and therefore the direct comparison of acellular dermal matrix and non–acellular dermal matrix breast reconstruction was not possible. Although there are several limitations to this study, the authors conclude that they could not recommend prolonged postoperative antibiotic use based on the available evidence.

Phillips and colleagues have most recently published results of a prospective, randomized, controlled trial of two different antibiotic regimens in immediate tissue-expander breast reconstruction.21 They compared 24 hours of postoperative antibiotics with antibiotics until drain removal in a noninferiority designed trial. Surgical-site infection was defined using the Centers for Disease Control and Prevention classification and included everything from cellulitis to implant removal caused by infection. An analysis of 112 patients (180 breasts) revealed an infection rate of 19.35 percent compared with 22.0 percent in the less than 24 hour and until drain removal groups, respectively. Patients in the less than 24 hour group were found in general to have earlier infections that were more likely to resolve with oral antibiotics. The longer duration group had more patients with later infections that more often resulted in expander loss. These results were not statistically different. The overall results support the concept that 24 hours of antibiotics is not inferior to an extended postoperative regimen in implant-based breast reconstruction in a Level I evidence study.

A recent retrospective study by McCullough et al. confirmed findings from the previous randomized trial.23 This group examined immediate tissue expander breast reconstruction patients who received only preoperative antibiotics and compared infectious outcomes to those in patients who received postoperative antibiotics. They found an overall 12.7 percent infection rate, with 13.5 percent and 12.0 percent in the preoperative and postoperative groups, respectively. Interestingly, the study did not notice a decreased surgical-site infection rate over the study period despite the trend of increased antibiotic use by their surgeons. Patients who received postoperative antibiotics were also more likely to grow resistant organisms when cultured. A limitation of this study is the confusing definition of its two cohorts. The “preoperative” group does not state whether these patients received additional intraoperative or postoperative antibiotics while the patient was in the hospital. The “postoperative” group is defined as consisting of those given oral antibiotics after discharge. The duration of antibiotics is based on surgeon preference and was not clearly delineated. This study and a previous study by Clayton et al. examined similar antibiotic protocols with conflicting results.18 Although Clayton and colleagues looked at a more heterogeneous sample of breast reconstruction patients, it is hard to completely understand the completely opposing findings. Additional prospective, multicenter, randomized clinical results are needed to determine the optimal duration of and necessity for postoperative antibiotics in breast reconstruction patients.

Limitations of this review include the inherent limitations of the presented articles. Our goal was to present the current available literature and provide expert opinion on the necessary duration of antibiotics in prosthetic breast reconstruction. To answer this question, we have provided the most relevant original and review articles. Unfortunately, the presentation of data in these articles limits our ability to take away definitive answers. The definition of infection and standardization of reporting is not universal. The separation of type, timing, and stage of breast reconstruction can also not be separated in these articles. Future articles should address not only the question of antibiotic duration but also standardization of outcome reporting.

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CONCLUSIONS

The literature contains conflicting data regarding the optimal duration for perioperative antibiotic prophylaxis following prosthetic breast reconstruction. The literature does not support prolonged (>24 hours) postoperative antibiotic use in autologous breast reconstruction. The authors’ opinion is that at least 24 hours of antibiotic prophylaxis is warranted following mastectomy with expander or implant-based reconstruction. Level I evidence suggests that 24 hours is not inferior to prolonged antibiotics, and therefore we recommend limiting postoperative antibiotic use to 24 hours. It is possible that prolonged (>24 hours) antibiotic exposure increases the risk of more resistant bacteria and more severe infections. Further prospective, randomized, controlled trials are warranted. Patient-centered antibiotic prophylaxis based on a risk-assessment model may be a more effective alternative to the current indiscriminate model of surgical-site infection control, and may help delineate which patients might benefit, if at all, from prolonged postoperative antibiotic prophylaxis.

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