In a study reported in JAMA Oncology, researchers in the Prophylactic Antibiotic Regimens in Tumor Surgery Investigators group found that 5 days vs 1 day of postoperative intravenous antibiotic prophylaxis did not reduce the incidence of surgical site infection and was associated with more antibiotic-related complications among patients undergoing surgical excision and endoprosthetic reconstruction for lower-extremity bone tumors.

Study Details

In the double-blind trial, 604 evaluable patients from sites in 12 countries were randomly assigned between January 2013 and October 2019 to receive 5 days of  IV cephalosporin (cefazolin or cefuroxime) starting 8 hours after skin closure and every 8 hours thereafter (n = 293) or 1 day of treatment followed by saline doses every 8 hours for the remaining 4 days (n = 311). Patients had a primary bone tumor, a soft-tissue sarcoma invading the femur or tibia, or oligometastatic bone disease of the femur or tibia requiring surgical excision and endoprosthetic reconstruction.

The primary outcome measure was surgical site infection (superficial incisional, deep incisional, or organ space) within 1 year after surgery.

Key Findings

Surgical site infection occurred in 44 patients (15.0%) in the 5-day group vs 52 patients (16.7%) in the 1-day group within 1 year (hazard ratio [HR] = 0.93, 95% confidence interval [CI] = 0.62–1.40, P = .73).

Antibiotic-related complications occurred in 15 patients (5.1%) in the 5-day group vs 5 patients (1.6%) in the 1-day group (HR = 3.24, 95% CI = 1.17–8.98, P = .02), with the most common being Clostridioides difficile–associated colitis.

Within 1 year after surgery, unplanned additional operations occurred in 25.6% vs 25.7% of patients (HR = 1.06, 95% CI = 0.77–1.46, P = .72), oncologic events (eg, local recurrence, distant metastasis) occurred in 29.0% vs 28.6% (HR = 1.02, 95% CI = 0.75–1.39, P = .90), death from any cause occurred in 12.6% vs 12.8% (HR = 1.01, 95% CI = 0.64–1.58, P = .98), and death from disease progression occurred in 9.9% vs 9.3% (HR = 1.08, 95% CI = 0.64–1.81, P = .78). No significant differences in surgeon-reported or patient-reported functional outcomes were observed.

The investigators concluded, “This randomized clinical trial did not confirm the superiority of a 5-day regimen of postoperative intravenous antibiotics over a 1-day regimen in preventing surgical site infections after surgery for lower-extremity bone tumors that required an endoprosthesis. The 5-day regimen group had significantly more antibiotic-related complications.”

Michelle Ghert, MD, of the Division of Orthopaedic Surgery, McMaster University, Hamilton, is the corresponding author for the JAMA Oncology article.

Disclosure: The study was supported by the Canadian Institutes of Health Research, Canadian Cancer Society Research Institute, and others. For full disclosures of the study authors, visit jamanetwork.com.