RESUMEN
BACKGROUND: Data on the benefits of preoperative prophylactic antibiotics for breast surgery are conflicting, and there is no specific guideline for their use in wire-localized lumpectomy. PATIENTS AND METHODS: This is a proof-of-concept, single-blind randomized controlled trial carried out from April 2018 to June 2019 at the Centre des Maladies du Sein du CHU de Québec - Université Laval. The objectives were to determine whether a single dose of preoperative antibiotics reduces surgical site infection (SSI) after wire-localized lumpectomy and to identify the risk factors for SSI. The patients were randomized to receive preoperative prophylactic antibiotics or not. SSI was defined by positive breast wound cultures, abscess drainage, and/or antibiotics given for clinical signs of breast infection within 30 days of the operation. This study was registered with ClinicalTrials.gov, NCT04818931. RESULTS: A total of 330 patients were enrolled. Eighteen patients were excluded. The SSI rate was 3.1% (5/160) in the antibiotic group versus 5.9% (9/152) in the control group (p = 0.28). Only obesity was a significant risk factor for SSI. All cases of SSI were treated routinely with antibiotics; one patient required wound re-opening. None of the SSIs delayed the adjuvant treatment. CONCLUSION: Preoperative antibiotic prophylaxis does not significantly decrease the occurrence of breast SSI. It is safe to omit prophylactic antibiotics for a wire-localized lumpectomy. This could also decrease the treatment costs and avoid unnecessary side effects.