Antibiotic prophylaxis in breast cancer surgery. A randomized controlled trial

Abstract Purpose To assess the effect of antibiotic prophylaxis on surgical site infection (SSI) rates in women undergoing breast cancer surgery in two tertiary hospitals in Brazil. Methods This was a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 124 women without independent risk factors for SSI were randomly assigned to receive either cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis. After surgery, all surgical wounds were examined once a week, for four weeks, according to the Centers for Disease Control and Prevention definitions and classifications for SSI. Results Baseline characteristics were homogeneous between the two groups. Only one patient in the antibiotic group developed SSI, which was classified as superficial incisional. The overall SSI rate was low, with no significant difference between groups. Conclusion Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.

摘要 目的：评估巴西两所三级医院内，接受乳腺癌手术且无手术部位感染（surgical site infection, SSI）独立危险因素的女性患者中，预防性抗生素应用对手术部位感染发生率的影响。方法：本研究为随机、双盲、安慰剂对照的平行分组临床试验。共计纳入124名无手术部位感染独立危险因素的女性受试者，按随机分配原则分别于术前接受头孢唑林（抗生素组，n=62）或安慰剂（对照组，n=62）预防性给药。术后依据美国疾病控制与预防中心（Centers for Disease Control and Prevention, CDC）制定的手术部位感染定义与分类标准，对所有手术切口进行为期4周、每周1次的随访观察。结果：两组患者基线特征具有同质性。抗生素组仅1例患者发生手术部位感染，分类为浅表切口感染。整体手术部位感染发生率较低，两组间差异无统计学意义。结论：对于无手术部位感染独立危险因素、接受乳腺癌手术的女性患者，预防性抗生素应用未能显著降低手术部位感染发生率。