Withholding postoperative antibiotics in pediatric circumcision: A randomized non-inferiority trial in a tropical setting

Abstract

Background Routine antibiotic prescription is commonly practiced in pediatric circumcision, despite limited evidence supporting its benefit in clean elective procedures. This study aimed to determine whether withholding routine antibiotics is non-inferior to standard postoperative administration in preventing surgical site infections (SSIs) in healthy children undergoing elective circumcision. Methods This single-center, randomized, non-inferiority trial enrolled boys aged 5–15 years scheduled for elective circumcision. Participants were allocated to receive either standard postoperative oral antibiotics or no antibiotics. The primary outcome was an SSI within 21 days, assessed by blinded evaluators, with non-inferiority defined as an upper limit of the 95% confidence interval (CI) for the risk difference of <5%. Results Of 175 screened patients, 155 were included in the per-protocol analysis (80 antibiotics; 75 no antibiotics). SSIs occurred in one patient in each group (1.3% vs. 1.3%), yielding a risk difference of 0.0% (95% CI −3.8% to 3.8%), which met the non-inferiority criterion. Secondary outcomes were comparable between the groups, and no serious adverse events were observed. Conclusion Withholding antibiotics in healthy children undergoing elective circumcision is non-inferior to routine postoperative use with respect to infection risk and supports an antibiotic-sparing approach consistent with antimicrobial stewardship principles. Trial Registration: Thai Clinical Trials Registry (TCTR20250818001).