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Context: Surgical site infection (SSI) in the general surgical population is a significant public health issue. The use of a high fractional inspired concentration of oxygen (FIO2) during the perioperative period has been reported to be of benefit in selected patients, but its role as a routine intervention has not been investigated., Objective: To determine whether the routine use of high FIO2 during the perioperative period alters the incidence of SSI in a general surgical population., Design, Setting, and Patients: Double-blind, randomized controlled trial conducted between September 2001 and May 2003 at a large university hospital in metropolitan New York City of 165 patients undergoing major intra-abdominal surgical procedures under general anesthesia., Interventions: Patients were randomly assigned to receive either 80% oxygen (FIO2 of 0.80) or 35% oxygen (FIO2 of 0.35) during surgery and for the first 2 hours after surgery., Main Outcome Measures: Presence of clinically significant SSI in the first 14 days after surgery, as determined by clinical assessment, a management change, and at least 3 prospectively defined objective criteria., Results: The study groups were closely matched in a large number of clinical variables. The overall incidence of SSI was 18.1%. In an intention-to-treat analysis, the incidence of infection was significantly higher in the group receiving FIO2 of 0.80 than in the group with FIO2 of 0.35 (25.0% vs 11.3%; P =.02). FIO2 remained a significant predictor of SSI (P =.03) in multivariate regression analysis. Patients who developed SSI had a significantly longer length of hospitalization after surgery (mean [SD], 13.3 [9.9] vs 6.0 [4.2] days; P<.001)., Conclusions: The routine use of high perioperative FIO2 in a general surgical population does not reduce the overall incidence of SSI and may have predominantly deleterious effects. General surgical patients should continue to receive oxygen with cardiorespiratory physiology as the principal determinant.