Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
The OXYGEN Study is a double blinded prospective randomized controlled trial that will compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
• All high energy tibial plateau fractures treated operatively with plate and screw fixation. We define high energy tibial plateau fractures as patients who are either:
‣ Initially treated with an external fixation and treated more than 7 days later after swelling has resolved.
⁃ Gustilo Type I, II, and IIIA open fracture, regardless of timing of definitive treatment.
• All high energy pilon (distal tibial plafond) fractures treated operatively with plate and screw fixation. We define high energy tibial plateau fractures as patients who are either:
‣ Initially treated with an external fixation (with or without fibula fixation or limited internal fixation) and treated definitively more than 7 days later after swelling has resolved.
⁃ Gustilo Type I, II, and IIIA open fracture, regardless of timing of definitive treatment.
• All high energy calcaneus fractures treated operatively with plate and screw fixation in a staged fashion. We define high energy calcaneus fractures as patients who are either:
‣ Treated definitively more than 7 days later after swelling has resolved.
⁃ Gustilo Type Type I, II, and IIIA \[30,31\] open fracture, regardless of timing of definitive treatment.
• Ages 18 to 80 years
• Patients may have co-existing infection not at study fracture site, with or without antibiotic treatment.
• Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• Patients may have a head injury.
• Patients may be treated initially with a temporary external fixator prior to randomization.
• Patients may have a portion of the fixation (e.g. fibula fixation in pilon or percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at any initial surgery before randomization for definitive fixation.
• Patients may have other orthopedic and non-orthopaedic injuries.
• Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries.