Effect of Supplemental Perioperative Oxygen on SSI Among Adults with Lower-Extremity Fractures at Increased Risk for Infection

Abstract

Background:Supplemental perioperative oxygen is a low-cost intervention theorized to reduce the risk of surgical site infections, but its effect among patients undergoing surgery for a tibial plateau, tibial pilon, or calcaneal fracture is unknown. We aimed to determine the effectiveness of a high fraction of inspired oxygen (FiO2, 80%) versus low FiO2 (30%) in reducing surgical site infections in these patients.Methods:A randomized controlled trial was conducted at 29 U.S. trauma centers. We enrolled 1,231 patients who were 18 to 80 years of age and had a tibial plateau, tibial pilon, or calcaneal fracture and were thought to be at elevated risk for infection based on their injury characteristics. Patients were randomized to receive 80% FiO2 (treatment group) or 30% FiO2 (control group) in the operating room and for up to 2 hours in the recovery room. The primary outcome was a composite of either deep surgical site infection (treated with surgery) or superficial surgical site infection (treated with antibiotics alone) within 182 days following definitive fixation. Secondary outcomes included these surgical site infections at 90 and 365 days after surgery.Results:The modified intention-to-treat analysis included 1,136 patients with 94% of expected follow-up through 182 days. Surgical site infection occurred in 40 (7.0%) of the patients in the treatment group and 60 (10.7%) of the patients in the control group (relative risk [RR], 0.65; 95% confidence interval [CI], 0.45 to 0.96; risk difference [RD], −3.8%; 95% CI, −7.2% to −0.4%; p = 0.03). The treatment intervention demonstrated a similar effect at 90 days (RR, 0.59; 95% CI, 0.37 to 0.93) and 365 days (RR, 0.62; 95% CI, 0.44 to 0.87). Secondary analyses demonstrated that the effect was driven by a reduction in superficial surgical site infections.Conclusions:Among tibial plateau, pilon, or calcaneal fracture patients at elevated risk for surgical site infection, a high perioperative FiO2 lowered the risk of surgical site infection. The findings support the use of this intervention, although the benefit appears to mostly be in reduction of superficial infections.Level of Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Deep Surgical Site Infection after Fracture Has a Profound Effect on Functional Outcomes

“…This secondary analysis utilized data collected in the VANCO trial (Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection) 26 and the OXYGEN (Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery) 27 trial. The VANCO trial was a randomized controlled trial ( ClinicalTrials.gov number NCT02227446) designed to evaluate local antibiotic therapy to reduce infection after the operative treatment of fractures at high risk for infection, and the OXYGEN trial was a randomized controlled trial ( ClinicalTrials.gov number NCT01798810) designed to evaluate supplemental perioperative oxygen to reduce deep surgical site infection after high-energy fracture.…”

The Role of Combined Inflammatory Biomarkers in the Diagnosis of High- and Low-Virulence FRI Among High-Risk Lower Extremity Fractures

“…Inclusion criteria for enrollment were as follows (1) Over 18 years old; (2) Imaging diagnosis of a tibial plateau/ calcaneus / Pilon fracture; (3) Conforming to the definition of high-risk lower extremity fractures, which involved with a delayed definitive treatment at >3 days after the injury/a multistage treatment due to a soft tissue problem; 9 , 10 (4) follow-up more than a year. Exclusion criteria included (1) Open or pathologic fractures at the surgical site; (2) Incomplete medical records; (3) Evacuation from this study during follow-up ( Figure 1 ).…”