Surgical Site Infection and the Routine Use of Perioperative Hyperoxia in a General Surgical Population: A Randomized Controlled Trial

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