Extra oxygen during surgery may cut infection risk after bad breaks
NCT ID NCT01798810
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving patients extra oxygen (80% FiO2) during surgery could reduce surgical site infections after severe tibial plateau or pilon fractures. Over 1,100 patients were randomly assigned to receive either supplemental oxygen or standard care. The main goal was to see if infection rates within 6 months were lower in the oxygen group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Supplemental perioperative oxygen (80% FiO2 during surgery)
- What this could lead to
- If it works, this could provide a simple, low-cost way to lower infection rates after high-energy fracture surgery.
- What could go wrong
- This is a completed trial, but the intervention is a procedural change, not a drug. The benefit may be small or not apply to all fracture types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,171 people
The number who actually took part.
- Start date
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Jun 2013
- Finished
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Jun 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner University Medical Center/The CORE Institute
Phoenix, Arizona, 85023, United States
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University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
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