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OBJECTIVE Infection is one of common complications after prosthetic material hernia repair surgery.Antibiotic prophylaxis is applied routinely in China,but its effect is still controversial.The present study aims to offer direct clinical evidence on prevention of infection after tension-free inguinal hernia repair.MEDTHODS A total of 1200 cases with primary inguinal hernia treated in 6 hospitals in Shaanxi Province were enrolled in this study.They were randomly divided into three groups (n = 400 per group): placebo control group,Cefazolin group and Levofloxacin group after tension-free inguinal hernia repair using polypropylene mesh.Hernia type,age,gender,weight and complications were recorded.The surgical-site infection was diagnosed according to APIC,CDC criteria (http://www.apic.org).Infections were evaluated every other day in the first week,and then on 14 days,21 days and 30 days following surgery.RESULTS Two cases from placebo group,3 from Cefazolin group and 3 from Levofloxacin group failed to follow-up.Six patients (2 non-following the protocol,2 severe depression and 2 laparoscopic surgery) from placebo group,14 (8 non-receiving trial medication,5 laparoscopic surgery and 1 failure to tolerance) from Cefazolin group,and 12 (2 combination of antibiotic usage,5 laparoscopic surgery and 5 failure to tolerance) from Levofloxacin group were excluded.The data of the 1160 cases were statistically analyzed in the incidence rates of surgical-site infection and complications after inguinal hernia repair.Surgical-site infection including wound infection,cellulitis or mesh-related infection was found in 20 cases (5.1%) of control group,15 (3.92%) of Cefazolin group and 17 (4.42%) of Levofloxacin group,and the difference among three groups was not statistically significant ( χ 2 = 0.438,P = 0.803).There was also no significant difference in post-surgery complications including Seroma(P =0.6366),urinary retention (P = 0.8136),fat liquefaction (P = 0.8061),seroma (P = 0.6366),pulmonary infection (P = 0.1911) and urinary tract infection (P = 0.8144) among three groups.CONCLUSIONS Prophylactic use of Cefazolin or Levofloxacin did not significantly decrease the risk of wound infection in these patients undergoing inguinal hernia repair.The present results do not support the administration of antibiotic prophylaxis for tension-free inguinal hernia repair.