A randomized trial of antibiotic prophylaxis for the prevention of surgical site infection after open mesh-plug hernia repair.

The efficacy of antibiotic prophylaxis for the prevention of surgical-site infection (SSI) after open tension-free inguinal hernia repair remains controversial. A double-blind, randomized, placebo-controlled trial was conducted. Patients who underwent elective open mesh-plug hernia repair were eligible for randomization. In the antibiotic prophylaxis group, 1.0 g cefazolin was intravenously administrated 30 minutes before the incision. In the placebo group, an equal volume of sterile saline was administered. The primary end point was the incidence of SSI. A total of 200 patients were enrolled. SSI developed in 2 of 100 patients (2%) in the antibiotic prophylaxis group and 13 of 100 patients (13%) in the placebo group, indicating a significant difference between the 2 groups (relative risk ratio, 0.25; 95% confidence interval, 0.070 to 0.92; P = .003). Other complications occurred in 23 patients: 7 (7%) in the antibiotic prophylaxis group and 16 (16%) in the placebo group (P = .046). This study indicates that antibiotic prophylaxis is effective for the prevention of SSI after open mesh-plug hernia repair.