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Extra oxygen during surgery may cut infection risk after bad breaks

NCT ID NCT01798810

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

1,171 people

The number who actually took part.

Start date

Jun 2013

Finished

Jun 2022

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Banner University Medical Center/The CORE Institute

    Phoenix, Arizona, 85023, United States

  • University of Maryland R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

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