PAUS trial concludes Antibiotic prophylaxis as "ineffective" for breast cancer surgery patients: BJS

UK: A recent study published in the British Journal of Surgery mentioned that a single preoperative dose of amoxicillin–clavulanic acid is statistically insignificant in reducing wound infection in patients after 30 days of breast cancer surgery and, therefore, may not be needed. As highlighted by the PAUS (Prophylactic Antibiotic Use in Surgery) trial, unnecessary antibiotic use should be cut down.

Prevention of infection is an integral part of cancer treatment. The uncertain efficacy of antibiotic prophylaxis remains arguable in cancer treatment. The availability of data on antibiotic prophylaxis's role in breast cancer patients remains limited.

Against the above background, Dr. Sheila Stallard from Gartnavel General Hospital conducted a double-blind parallel-group multicentre superiority trial called "PAUS Trial" to question: 'Do preoperative antibiotics pose benefits for breast cancer surgery patients?'

Dr. Francesca Savioli, the co-researcher of the trial from the Academic Unit of Surgery at the School of Medical, Veterinary and Life Sciences from the University of Glasgow, mentioned," Our study aimed to test if wound infection gets reduced by a single dose of amoxicillin–clavulanic at 30 days postoperatively as the primary outcome. We also aimed to identify risk factors associated with the infection."

The key points of the trial are:

• The 871 evaluable participants agreed to participate in the trial and had a history of invasive breast cancer undergoing primary surgery.

• The study had two groups: Intervention and control.

• The 438 participants in the intervention group received a single bolus of 1.2 g amoxicillin–clavulanic acid intravenously after anesthesia induction at the time of operation.

• The 433 participants in the control group received no antibiotics.

• Seventy-one patients developed a wound infection by 30 days in the intervention group.

• In the control group, 83 patients developed infections.

• The odds ratio (OR) was 0.82 with a P value of  0.250, which was statistically insignificant.

• With every 5 kg/m2 BMI, the risk of infection increased with OR 1.29 and the P value of 0.003.

• The PAUS trial showed no difference in wound infection reduction when comparing the intervention and the control group.

The authors wrote," 16.2 % of participants in the intervention group developed wound infection compared to 19.2 % in the control group; therefore, it can be concluded that antibiotics are not required in breast cancer surgery. We observed that carriers of Staphylococcus aureus (preoperatively) were associated with an increased risk of postoperative wound infection."

The trial concluded that preoperative antibiotics are not beneficial with a high BMI or for carriers of S. aureus.

Further reading:

Sheila Stallard, Francesca Savioli, Alex McConnachie, John Norrie, Katie Dudman, Elizabeth S Morrow, Laszlo Romics, Antibiotic prophylaxis in breast cancer surgery (PAUS trial): randomized clinical double-blind parallel-group multicentre superiority trial, British Journal of Surgery, 2022