Comparison of Prophylactic Intravenous Antibiotic Regimens After Endoprosthetic Reconstruction for Lower Extremity Bone Tumors: A Randomized Clinical Trial

Key Points

• The study compared a 5-day prophylactic antibiotic regimen with a 1-day regimen in patients undergoing surgical resection and endoprosthetic reconstruction for lower extremity bone tumors.
• No statistically significant difference in surgical site infection rates between the 5-day and 1-day regimens.
• Significantly higher rate of serious antibiotic-related complications, mainly Clostridioides difficile–associated colitis, in the 5-day regimen group.

Strengths

• Randomized clinical trial design with concealed randomization and blinding for minimizing biases.
• Low loss to follow-up (5%).
• Broad eligibility criteria increase generalizability.

Limitations

• Low enrollment at some clinical sites due to the rarity of bone tumors.
• Imbalance in preoperative chemotherapy between groups, although adjusted analyses yielded similar results.

• Protocol deviations occurred, mostly due to early hospital discharge.