The OXYGEN Study is a phase III double-blind RCT conducted across 19 METRC trauma centers. It tests whether FiO2 80% versus FiO2 30% reduces surgical site infection after plate fixation of high-risk tibial plateau, pilon, and calcaneus fractures. This paper describes the study protocol — no efficacy results are reported.
SSI after high-energy fracture fixation carries enormous personal and societal costs, yet no large RCT had established whether a simple intraoperative tweak — turning up the oxygen — could prevent it in orthopaedic trauma patients.
Data from abdominal and colorectal surgery were mixed, and orthopaedic trauma wounds are fundamentally different: injured soft tissue, metal implants, tourniquets, and exposure to different pathogens all make extrapolation unreliable.
When you fix a tibial plateau, pilon, or calcaneus fracture in a patient who meets any of the three high-risk criteria (delay greater than 3 days, Gustilo I–IIIA open fracture, or prior fasciotomy), the baseline infection risk approaches 14% — far higher than most surgeons appreciate.
If the OXYGEN Study results show benefit, FiO2 80% intraoperatively plus high-flow non-rebreather mask at 15 L/minute for 2 hours postoperatively would be one of the lowest-barrier interventions in trauma surgery: no new equipment, no added cost, and no change to the operative technique.
The OXYGEN Study is a phase III double-blind RCT conducted across 19 METRC trauma centers. It tests whether FiO2 80% versus FiO2 30% reduces surgical site infection after plate fixation of high-risk tibial plateau, pilon, and calcaneus fractures. This paper describes the study protocol — no efficacy results are reported.
SSI after high-energy fracture fixation carries enormous personal and societal costs, yet no large RCT had established whether a simple intraoperative tweak — turning up the oxygen — could prevent it in orthopaedic trauma patients.
Data from abdominal and colorectal surgery were mixed, and orthopaedic trauma wounds are fundamentally different: injured soft tissue, metal implants, tourniquets, and exposure to different pathogens all make extrapolation unreliable.
When you fix a tibial plateau, pilon, or calcaneus fracture in a patient who meets any of the three high-risk criteria (delay greater than 3 days, Gustilo I–IIIA open fracture, or prior fasciotomy), the baseline infection risk approaches 14% — far higher than most surgeons appreciate.
If the OXYGEN Study results show benefit, FiO2 80% intraoperatively plus high-flow non-rebreather mask at 15 L/minute for 2 hours postoperatively would be one of the lowest-barrier interventions in trauma surgery: no new equipment, no added cost, and no change to the operative technique.