• Michael Gallagher, Daniel J Jones, and Sophie V Bell-Syer.
• Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, South Kensington Campus, London, UK, SW7 2AZ.
• Cochrane Db Syst Rev. 2019 Sep 26; 9 (9): CD005360CD005360.

BackgroundSurgery has been used as part of breast cancer treatment for centuries; however any surgical procedure has the potential risk of infection. Infection rates for surgical treatment of breast cancer are documented at between 3% and 15%, higher than average for a clean surgical procedure. Pre- and perioperative antibiotics have been found to be useful in lowering infection rates in other surgical groups, yet there is no consensus on the use of prophylactic antibiotics for breast cancer surgery. This is an update of a Cochrane Review first published in 2005 and last updated in 2014.ObjectivesTo determine the effects of prophylactic (pre- or perioperative) antibiotics on the incidence of surgical site infection (SSI) after breast cancer surgery.Search MethodsFor this fourth update, in August 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase; and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.Selection CriteriaWe included randomised controlled trials of pre- and perioperative antibiotics for patients undergoing surgery for breast cancer. Primary outcomes were rates of surgical site infection (SSI) and adverse reactions.Data Collection And AnalysisThree review authors independently examined the title and abstracts of all studies identified by the search strategy, then assessed study quality and extracted data from those that met the inclusion criteria. We contacted study authors to obtain missing information. We evaluated the certainty of evidence using the GRADE approach. We used standard methodological procedures expected by Cochrane.Main ResultsA total of 11 randomised controlled trials (2867 participants) were included in the review. No new studies were identified in this update. All studies included breast cancer patients and were based in the hospital setting. Ten studies evaluated preoperative antibiotic compared with no antibiotic or placebo. One study evaluated perioperative antibiotic compared with placebo or no antibiotic. Pooling of the results demonstrated that prophylactic antibiotics administered preoperatively probably reduce the incidence of SSI for patients undergoing breast cancer surgery without reconstruction (pooled risk ratio (RR) 0.67, 95% confidence interval (CI) 0.53 to 0.85; moderate certainty evidence). Anticipated absolute effects were calculated for the outcome incidence of SSI; 105 per 1000 for the none or placebo group and 71 per 1000 (95% CI 56 to 89) for the preoperative antibiotic prophylaxis group. Analysis of the single study comparing perioperative antibiotic with no antibiotic was inconclusive for incidence of SSI (RR 0.11, 95% CI 0.01 to 1.95; very low certainty evidence). No studies presented separate data for patients who underwent reconstructive surgery at the time of removal of the breast tumour.Secondary outcomes were not consistently included in the studies investigating preoperative antibiotic prophylaxis. It is very uncertain whether there is a difference in incidence of adverse events between the treatment and no treatment or placebo groups (10 studies, 2818 participants); very low certainty evidence downgraded one level for serious risk of bias, one level for serious inconsistency and one level for serious imprecision. It is unclear whether there is a difference in time to onset of infection between the treatment and no treatment or placebo groups (4 studies, 1450 participants); low certainty evidence downgraded one level for serious risk of bias and one level for serious inconsistency. It is unclear whether there is a difference in rates of readmission to hospital between the treatment and placebo groups (3 studies, 784 participants); low certainty evidence downgraded one level for serious inconsistency and one level for serious risk of bias. It is unclear whether there is a difference in cost of care between the treatment and no treatment or placebo groups (2 studies, 510 participants); low certainty evidence downgraded one level for serious risk of bias and one level for serious inconsistency. No analysable secondary outcome data were reported for the single study evaluating perioperative antibiotics.Authors' ConclusionsProphylactic antibiotics administered preoperatively probably reduce the risk of SSI in patients undergoing surgery for breast cancer. However, it is very uncertain whether there is an effect on incidence of adverse events. Furthermore, the effects on time to onset of infection, readmission to hospital and cost of care remain unclear. Further studies are required to establish the best protocols for clinical practice.

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