Abstract Background Participants were patients with invasive breast cancer undergoing primary surgery. The aim was to test whether a single dose of amoxicillin–clavulanic acid would reduce wound infection at 30 days postoperatively, and to identify risk factors for infection. Methods Participants were randomised to either a single bolus of 1.2 g intravenous amoxicillin–clavulanic acid after the induction of anaesthesia (intervention) or no antibiotic (control). The primary outcome was the incidence of wound infection at 30 days postoperatively. Results There were 871 evaluable patients. Of these, 438 received prophylactic antibiotic and 433 served as controls. Seventy-one (16.2 per cent) patients in the intervention group developed a wound infection by 30 days, while there were 83 (19.2 per cent) infections in the control group. This was not statistically significant (odds ratio (OR) 0.82, 95 per cent c.i. 0.58 to 1.15; P = 0.250). The risk of infection increased for every 5 kg/m2 of BMI (OR 1.29, 95 per cent c.i. 1.10 to 1.52; P = 0.003). Patients who were preoperative carriers of Staphylococcus aureus had an increased risk of postoperative wound infection; however, there was no benefit of preoperative antibiotics for patients with either a high BMI or who were carriers of S. aureus. Conclusion There was no statistically significant or clinically meaningful reduction in wound infection at 30 days following breast cancer surgery in patients who received a single dose of amoxicillin–clavulanic acid preoperatively. Registration number N0399145605 (National Research Register).

中文翻译：

---

乳腺癌手术中的抗生素预防（PAUS 试验）：随机临床双盲平行组多中心优越性试验

摘要 背景参与者是接受初次手术的浸润性乳腺癌患者。目的是测试单剂量阿莫西林克拉维酸是否可以减少术后 30 天的伤口感染，并确定感染的危险因素。 方法参与者被随机分配到麻醉诱导后单次静脉注射 1.2 g 阿莫西林克拉维酸（干预）或不使用抗生素（对照）。主要结果是术后 30 天伤口感染的发生率。 结果有 871 名可评估患者。其中 438 人接受了预防性抗生素治疗，433 人作为对照。30 天后，干预组中有 71 名患者（16.2%）出现伤口感染，而对照组有 83 名患者（19.2%）出现感染。这没有统计学意义（优势比 (OR) 0.82，95% CI 0.58 至 1.15；P = 0.250）。BMI 每增加 5 kg/m2，感染风险就会增加（OR 1.29，95% CI 1.10 至 1.52；P = 0.003）。术前携带金黄色葡萄球菌的患者术后伤口感染的风险增加；然而，对于高 BMI 或金黄色葡萄球菌携带者来说，术前使用抗生素没有任何益处。 结论术前接受单剂阿莫西林克拉维酸的患者在乳腺癌手术后 30 天时，伤口感染没有显着或有临床意义的减少。 注册号码N0399145605（国家研究注册）。