Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study)

Abstract

Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation. Patients are block randomized (within center) in a 1:1 ratio to either treatment group (FiO2 80%) or control group (FiO2 30%) and stratified by each study injury location. Secondary objectives of the study are to compare species and antibacterial sensitivities of the bacteria in patients who develop SSIs, to validate a previously developed risk prediction model for the development of SSI after fracture surgery, and to measure and compare resource utilization and cost associated with SSI in the 2 study groups. SPO is a low cost and readily available resource that could be easily disseminated to trauma centers across the country and the world if proved to be effective.

Effect of intraoperative hyperoxia on the incidence of surgical site infections: a meta-analysis

“…Two relatively large on-going trials will hopefully add power to future analyses: the iPROVE-O 2 study aims to randomise 756 patients undergoing abdominal surgery to 80% or 30% intraoperative inspiratory oxygen concentrations 58 ; and the OXYGEN study aims to randomise 1000 patients to 80% or 30% inspiratory oxygen concentration during, and for 2 h after, orthopaedic surgery. 59 In summary, published trials are heterogeneous. Our primary analysis using all qualifying trials shows that supplemental oxygen significantly reduces SSIs by about 20%.…”

Risk of Surgical Site Infections in OTA/AO Type C Tibial Plateau and Tibial Plafond Fractures: A Systematic Review and Meta-Analysis

“…21,22 Current research efforts have focused on minimizing the risk of SSIs in these fractures by examining promising modifications of surgical treatment protocols. [23][24][25] Given the significant socioeconomic impact of SSIs and the heightened interest within ongoing clinical investigations, there is an urgent need for identifying the specific risk of SSIs following surgical treatment of OTA/AO type C tibial plateau and plafond fractures. To our best knowledge, no systematic review and meta-analysis has comprehensively examined SSI incidence for these specific injuries.…”

Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox Within an Orthopaedic Trauma Clinical Trials Consortium

“…These "parent" studies included 3 studies of very severe, limb-threatening tibia fractures and amputations (FIXIT, OUTLET, and TAOS), 2 studies of slightly less severe lower-limb fractures (OXYGEN and VANCO), and 1 study of isolated, low severity fractures (Pain) all of which have been completed and previously described. [15][16][17][18][19][20] The key characteristics of these studies are shown in Supplemental Digital Content (see Table 1, http://links.lww.com/JOT/B602).…”