• Annals of surgery · Dec 2004

    Randomized Controlled Trial Multicenter Study Clinical Trial

    The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh repair of primary inguinal hernia: a multicenter double-blind randomized controlled trial.

    • Theo J Aufenacker, Dirk van Geldere, Taco van Mesdag, Astrid N Bossers, Benno Dekker, Edo Scheijde, Roos van Nieuwenhuizen, Esther Hiemstra, John H Maduro, Jan-Willem Juttmann, Diederik Hofstede, Cunera T M van Der Linden, Dirk J Gouma, and Maarten P Simons.
    • Department of Surgery, Onze Lieve Vrouwe Gasthuis, Eerste Oosterparkstraat 279, 1091 HA Amsterdam, The Netherlands.
    • Ann. Surg. 2004 Dec 1; 240 (6): 955961955-60; discussion 960-1.

    ObjectiveTo determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair.Summary Background DataA recent Cochrane meta-analysis (2003) concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded."MethodsPatients with a primary inguinal hernia scheduled for Lichtenstein repair were randomized to a preoperative single dose of 1.5 g intravenous cephalosporin or a placebo. Patients with recurrent hernias, immunosuppressive diseases, or allergies for the given antibiotic were excluded. Infection was defined using the Centers for Disease Control and Prevention criteria.ResultsWe included 1040 patients in the study between November 1998 and May 2003. According to the intention-to-treat principle, 1008 patients were analyzed. There were 8 infections (1.6%) in the antibiotic prophylaxis group and 9 (1.8%) in the placebo group (P = 0.82). There was 1 deep infection in the antibiotic prophylaxis group and 2 in the placebo group (P = 0.57). Statistical analysis showed an absolute risk reduction of 0.19% (95% confidence interval, -1.78%-1.40%) and a number needed to treat of 520 for the total number of infections. For deep infection, the absolute risk reduction is 0.20% (95% confidence interval, -0.87%-0.48%) with a number needed to treat of 508.ConclusionsA low percentage (1.7%) of wound infection after Lichtenstein open mesh inguinal (primary) hernia repair was found, and there was no difference between the antibiotic prophylaxis or placebo group. The results show that, in Lichtenstein inguinal primary hernia repair, antibiotic prophylaxis is not indicated in low-risk patients.

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