Comparing Prophylactic Administration of Sulbactam/Ampicillin Versus Cefmetazole for Prevention of Perineal Wound Infection Following Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial

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Aim: Perineal wound infection (PWI) is a critical complication unique to abdominoperineal resection (APR) that requires preventive interventions. This study compared the efficacy of a 4-day regimen of sulbactam/ampicillin (SBT/ABPC) with that of a 1-day regimen of cefmetazole (CMZ) for preventing PWI after APR. Methods: Eighty patients who underwent APR for rectal cancer were enrolled in this multicenter, open-label, randomized controlled trial. The primary outcome was the incidence of PWI, and secondary outcomes included the incidence of surgical site infections (SSI), other complications, and length of postoperative hospital stay. Based on an assumed PWI incidence of 46% for CMZ and 14% for SBT/ABPC, a sample size of 40 participants per group was required to achieve a 90% power at a two-sided 10% significance level. Results: = 0.096) was significantly lower in the SBT/ABPC group than in the CMZ group, based on a planned two-sided significance level of 10%. SSI, other complications, including antibiotic-related adverse events, and length of postoperative hospital stay, were not significantly different between the two groups. SBT/ABPC demonstrated broader bacterial coverage than CMZ in the PWI treatment. Conclusion: The 4-day SBT/ABPC regimen significantly reduced the incidence of PWI after APR compared to the 1-day CMZ regimen. This simple approach to antibiotic selection may be beneficial for preventing PWI.

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