In a Swedish study reported in JAMA Network Open, Gahm et al found that multiple vs single doses of prophylactic intravenous (IV) antibiotics did not significantly reduce the risk of surgical site infection leading to implant removal in women undergoing implant-based breast reconstruction after therapeutic or risk-reducing mastectomy for breast cancer.
The multicenter trial included 698 women undergoing immediate or delayed implant-based breast reconstruction. They were randomly assigned between April 2013 and October 2018 to receive multiple IV antibiotic doses within 24 hours from surgery starting with the first dose preoperatively in the operating room (n = 353) or a single IV dose given preoperatively in the operating room. The first-choice antibiotic was cloxacillin at 2 g per dose, with clindamycin at 600 mg per dose used in patients with a penicillin allergy. The primary outcome measure was surgical site infection leading to surgical removal of the implant within 6 months after surgery.
At 6 months, surgical removal of the implant due to surgical site infection occurred in 17 patients (4.8%) in the multiple-dose group vs 13 patients (3.8%) in the single-dose group (odds ratio [OR] = 1.26, 95% confidence interval [CI] = 0.69–2.65, P = .53).
At 6 months, readmission for IV antibiotic treatment for surgical site infection had occurred in 26 patients (7.4%) in the multiple-dose group vs 21 (6.1%) in the single-dose group (OR = 1.18, 95% CI = 0.65–2.15, P = .58). Oral antibiotic treatment for suspected surgical site infection occurred in 85 patients (24.4%) in the multiple-dose group vs 105 (30.4%) in the single-dose group (OR = 0.72, 95% CI = 0.51–1.02, P = .07).
Adverse events considered related to antibiotic treatment occurred in 58 patients (16.4%) in the multiple-dose group vs 37 (10.7%) in the single-dose group (OR = 1.64, 95% CI = 1.05–2.55, P = .03). None of the adverse events were considered serious. Among all adverse events, the most common were loose stools (30%), rash (18%), and thrombophlebitis (8%).
The investigators concluded, “The findings of this randomized clinical trial suggest that multiple-dose antibiotic prophylaxis is not superior to a single-dose regimen in preventing surgical site infection and implant removal after implant-based breast reconstruction but comes with a higher risk of adverse events associated with antibiotic treatment.”
Jessica Gahm, MD, PhD, of the Department of Reconstructive Plastic Surgery, Karolinska University Hospital, Stockholm, is the corresponding author for the JAMA Network Open article.
Disclosure: The study was supported by the Swedish Breast Cancer Association and others. For full disclosures of the study authors, visit jamanetwork.com.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.