Effect of single-dose prophylactic ampicillin and sulbactam on wound infection after tension-free inguinal hernia repair with polypropylene mesh - The randomized, double-blind, prospective trial

Objective To assess the value of single-dose, intravenous, prophylactic ampicillin an d sulbactam (AS) in the prevention of wound infections during open prosthet ic inguinal hernia repair by a double-blind, prospective, randomized trial. Summary Background Data The use of antibiotic prophylaxis during open prosthetic inguinal hernia su rgery is controversial, and no prospective trial has been conducted to exam ine this issue. Methods Patients undergoing unilateral, primary inguinal hernia repair electively w ith the Lichtenstein technique using polypropylene mesh were randomized to receive 1.5 g intravenous AS before the incision or an equal volume of plac ebo according to a predetermined code of which the surgeons were unaware. P atients with recurrent, femoral, bilateral, giant, or incarcerated hernias or any systemic diseases were excluded. Age, sex, body mass index, American Society of Anesthesiologists score, type of hernia, type of anesthesia, du ration of surgery, and use of drains were recorded. Infection was defined a ccording to the criteria of Centers for Disease Control. Patients were eval uated 1 week, 1 month, 6 months, and 1 year after surgery by an independent surgeon. All complications were recorded. Results were assessed using chi- square, Fisher's exact, and Student t tests as appropriate. Results Between September 1996 and July 1998, 280 patients (140 AS, 140 placebo gro up) entered the protocol. Four patients from the AS group and seven from th e placebo group were excluded because of inadvertent antibiotic administrat ion or follow-up problems. Groups were well matched for all the variables s tudied and postoperative complications, excluding wound infections, which o ccurred at a rate of 0.7% in the AS group and 9% in the placebo group (P = .00153). Twelve patients in the placebo group developed wound infections, r equiring five repeat hospital admissions in three patients. These three pat ients suffered deep infections reaching the graft, which resulted in graft loss in two. The single infected patient in the AS group had his graft remo ved as well because of deep persistent infection. Conclusions This study documented a significant (10-fold) decrease in overall wound inf ections when single-dose, intravenous AS was used during Lichtenstein herni a repair. Deep infections and wound infection-related readmissions were als o reduced by the use of AS. Proponents of mesh repairs may therefore be adv ised to use prophylactic single-dose intravenous antibiotic coverage in the light of the results of this trial. AS proved to be an effective antimicro bial agent.