Prophylactic antibiotic use after cleft lip repair: Does it reduce complications, and is it necessary?

Abstract

Cleft lip repair (CLR) is one of the most common reconstructive surgeries performed for congenital conditions. Although perioperative surgical antibiotic prophylaxis (SAP) is commonly used, evidence supporting its benefit in CLR is limited. We performed a retrospective cohort study using the 2021-2024 American College of Surgeons Pediatric SAP Data Files. Infants ≤12 months who underwent primary CLR were categorized into three groups: no SAP, SAP without postoperative continuation, and SAP with continued postoperative IV antibiotics. Primary outcomes were 30-day SSI and readmission, which was evaluated using Firth penalized logistic regression. A prespecified subanalysis was performed in patients who underwent bilateral CLR (BCLR). A total of 4,966 patients met the inclusion criteria: 475 (9.6%) received no SAP, 3,250 (65.4%) received SAP without continuation, and 1,241 (25.0%) received SAP with postoperative continuation. SAP was administered to 90.4% of the patients, the most commonly used SAP was cefazolin (87.2%). The overall SSI rate was 0.7%. On multivariable analysis, neither SAP without continuation (OR 0.69, 95% CI 0.27-2.19, p=0.49) nor SAP with continuation (OR 0.61, 95% CI 0.20-2.12, p=0.41) were associated with decreased SSI. SAP was also not associated with reduced readmissions or composite complications. In the BCLR subanalysis, both SAP groups were significantly associated with decreased odds of SSI (OR 0.19 and 0.17, respectively; both p<0.05). In this multicenter cohort, SAP was not associated with reduced complications in the overall CLR population. However, patients who underwent BCLR and received SAP had significantly lower odds of SSI, indicating that this higher-risk subgroup may benefit from prophylaxis.