Status:
COMPLETED
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
Lead Sponsor:
Major Extremity Trauma Research Consortium
Conditions:
Post Operative Surgical Site Infection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 Perioper...
Detailed Description
Primary Objective To compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01798810
Start Date
June 1 2013
End Date
June 30 2022
Last Update
July 29 2022
Active Locations (2)
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1
Banner University Medical Center/The CORE Institute
Phoenix, Arizona, United States, 85023
2
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201