Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Su… (NCT01798810) | Clinical Trial Compass
CompletedNot Applicable
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
United States1,171 participantsStarted 2013-06
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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…