Antibiotic prophylaxis in breast cancer surgery (PAUS trial): randomised clinical double-blind parallel-group multicentre superiority trial

Stallard, S., Savioli, F., McConnachie, A. , Norrie, J., Dudman, K. , Morrow, E. S. and Romics, L. (2022) Antibiotic prophylaxis in breast cancer surgery (PAUS trial): randomised clinical double-blind parallel-group multicentre superiority trial. British Journal of Surgery, 109(12), pp. 1224-1231. (doi: 10.1093/bjs/znac280) (PMID:35932230)

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).

• Item Type: Articles
• Additional Information: This trial was funded by a grant from the charity, the British Society of Antimicrobial Chemotherapy (Grant Number GA391).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Dudman, Ms Katie and Norrie, Prof John and Romics, Mr Laszlo and McConnachie, Professor Alex and Morrow, Dr Elizabeth and Savioli, Ms Francesca
• Authors: Stallard, S., Savioli, F., McConnachie, A., Norrie, J., Dudman, K., Morrow, E. S., and Romics, L.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: British Journal of Surgery
• Publisher: Oxford University Press
• ISSN: 0007-1323
• ISSN (Online): 1365-2168
• Published Online: 06 August 2022
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in British Journal of Surgery 109(12): 1224-1231
• Publisher Policy: Reproduced under a Creative Commons License