Background: Higher concentrations of fraction of inspired oxygen (FIO2) have been shown to be associated with lower risk for surgical site infection in multiple studies outside the domain of orthopedic surgery. We evaluated the efficacy of high FIO2 administered during the perioperative period to reduce the rate of surgical site infection after open fixation of lower-extremity fractures at high risk of infection.
Methods: We conducted a randomized controlled, parallel design, double-blind study. Patients sustaining high-energy tibial plateau, tibial pilon, and calcaneus fractures treated in a staged fashion were selected for enrollment because these injuries are associated with high risk of infection. The study population included 222 patients with 235 fractures. Consenting patients were randomized by random number sequence to either the treatment or the control group. Treatment group patients received 80% FIO2 intraoperatively and for 2 hours afterward. Control group patients received 30% FIO2 during the same period. Surgeons, patients, and personnel who performed wound assessments were blinded to group assignment. The primary outcome measure was surgical site infection as defined by the Centers for Disease Control criteria for postoperative wound infection.
Results: The overall rates of postoperative surgical site infection were 12% (14 of 119 fractures) in the treatment group and 16% (19 of 116 fractures) in the control group (p = 0.31). Multivariate analysis, accounting for risk factors for infection, yielded the closest to a statistically significant reduction in the odds of infection with treatment (odds ratio, 0.54; p = 0.17). No treatment-associated events were observed.
Conclusion: Use of a high concentration of FIO2 during the perioperative period is safe and shows a trend toward reduction of surgical site infection in patients undergoing open operative fixation of high-energy traumatic lower-extremity fractures. Further study in a larger patient population is indicated.
Level of evidence: Therapeutic study, level III.