Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery

Completed · Not applicable

Conditions studied: Post Operative Surgical Site Infection

In brief

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.

Key facts

Study ID

NCT01798810

Run by

Major Extremity Trauma Research Consortium

People needed

1171

Starts

2013-06-01

Expected to finish

2022-06-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Tibial plateau, pilon, or calcaneus already infected at time of study enrollment.
• Type IIIB, or IIIC open [30,31] fractures
• Patient speaks neither English nor Spanish.
• Transfer patients who have already had definitive fixation.
• Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
• Patients who are intubated at the time of consent.
• Patients whose oxygen requirements at the time of surgery would prevent them from participating in either study group will be excluded.
• History of COPD or any other chronic respiratory disease that renders the patient oxygen dependent at baseline.
• Current or history of Bleomycin use (chemotherapy use associated with oxygen toxicity).
• Patient is currently pregnant.

Where it is running

• Banner University Medical Center/The CORE Institute — Phoenix, Arizona, United States
• University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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