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

Mazaki, Takero; Mado, Kazunari; Masuda, Hideki; Shiono, Motomi; Tochikura, Noahiro; Kaburagi, Morio

BACKGROUND The efficacy of antibiotic prophylaxis for the prevention of surgical-site infection (SSI) after open tension-free inguinal hernia repair remains controversial. METHODS 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. RESULTS 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). CONCLUSIONS This study indicates that antibiotic prophylaxis is effective for the prevention of SSI after open mesh-plug hernia repair.