Post Operative Surgical Site InfectionOXYGENNCT01798810
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
A study testing Supplemental Perioperative Oxygen in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Surgical Site Infection
- What is being tested?
- Supplemental Perioperative Oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,171 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Banner University Medical Center/The CORE Institute
Phoenix, Arizona, 85023
About this study
Official title: Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
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.
Read the 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 Perioperative Oxygen.
Secondary Objectives
To compare species and antibacterial sensitivities of the bacteria in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery
To measure and compare resource utilization and cost associated with surgical site infection in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Primary Aim: To 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.
Hypothesis 1: The proportion of surgical site infections will be lower for patients treated with Supplemental Perioperative Oxygen.
Secondary Aim #1: Compare bacterial species and antimicrobial susceptibilities in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Hypothesis 2: In the patients who develop infections, the bacterial species and antimicrobial susceptibility profiles of those treated with Supplemental Perioperative Oxygen will be similar to those treated without Supplemental Perioperative Oxygen.
Secondary Aim #2: To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery.
Hypothesis 3: The previously developed RIOTS score will be highly predictive of infection risk.
Secondary Aim #3: Measure and compare resource utilization and cost associated with surgical site infection in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Hypothesis 4: Supplemental Perioperative Oxygen will be associated with lower resource utilization and cost.
- Conditions
- Post Operative Surgical Site Infection
- Being tested
- Supplemental Perioperative Oxygen
- Keywords
- Surgical Site Infection Risk Prediction, Bacterial species type and antibacterial sensitivities, Resource Utilization and Cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Perioperative OxygenProcedure or surgery
Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Supplemental Perioperative Oxygen (80% FiO2) | Experimental | After intubation, patients in the Treatment Group will receive intraoperative inspired oxygen set at 80 percent (FiO2 of 0.80). Post-extubation, patients in the treatment arm will be placed on high flow non-re-breather mask at 15L/min for up to 2 hours postoperatively and then transitioned to nasal cannula, which will be weaned as tolerated. Receives: Procedure: Supplemental Perioperative Oxygen |
| Control (30% FiO2) | No intervention | After intubation, patients in the control arm will receive typical standard of care intraoperative inspired oxygen of 30 percent (FiO2 of 0.30). Post-extubation, patients in the control arm of the study will be placed on a nasal cannula at 4L/min to maintain SaO2≥92% as determined by pulse oximetry. This will be maintained for up to 2 hours and then weaned as tolerated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
The main outcome measure will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines.
Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS).
Measured: 26 weeks
Secondary outcomes (3)
Catalog and Compare Bacterial Species
Secondary outcome measures in this study include culture data in the group that becomes infected. Sensitivities of the isolated bacteria, which are also determined routinely in current clinical practice, will be recorded for analysis.
We will also describe the type of antibiotic resistance experienced in both groups. There are 3 specific types of antibiotic resistance that will be analyzed. These have been chosen because they are currently of most clinical importance in the treatment of surgical site infection after civilian fracture surgery.
- MRSA: Methicillin resistance staph aureus rates will be analyzed.
- VRE: Vancomycin resistant enterococcus rates will be analyzed.
- MDR GNR: Multi drug resistant gram negative rates will be analyzed.
Measured: 26 weeks
Risk Factors for Infection
Our previous work in the pilot study allowed us to propose a novel score to the risk of surgical site infection after high energy fracture surgery: the RIOTS (Risk of Infection for Orthopaedic Trauma Surgery. We will attempt to better validate our previous score on this larger multi-center dataset and further investigate if other risk factors for infection should be included.
Data collected includes all demographic characteristics of the patient, the descriptors of the injury, and details of the surgical treatment that would be available prior to the definitive surgery will be collected for analysis regarding determination of a model to predict infection risk in this patient population. These factors have been defined in previous work by this study team.
Measured: 26 weeks
Resource Utilization and Cost
Previous research has shown that SSI increases length of stay and overall cost of treatment for surgery patients. Three data sets in the case report forms will be used to document medical resource utilization associated with surgical site infections in this trial: initial hospital admission, hospital readmission for SSI, and follow-up visit forms. During scheduled follow-up visits study participants will be queried regarding post-discharge treatment that may be associated with SSI such as antibiotic infusion therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2019
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renan Castillo, PhD, Study director, Johns Hopkins Bloomberg School of Public HealthRobert O'Toole, MD, Principal investigator, University of Maryland R Adams Cowley Shock Trauma CenterAnthony Carlini, MS, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798810
- Sponsor's protocol ID
- W81XWH-12-1-0588
- Acronym
- OXYGEN
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2013
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
- ClinicalTrials.gov ID
- NCT01798810
- Acronym / sponsor ID
- OXYGEN / W81XWH-12-1-0588
- Conditions
- Post Operative Surgical Site Infection
- Keywords
- Surgical Site Infection Risk Prediction, Bacterial species type and antibacterial sensitivities, Resource Utilization and Cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,171 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2019 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Perioperative Oxygen.
Secondary Objectives
To compare species and antibacterial sensitivities of the bacteria in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery
To measure and compare resource utilization and cost associated with surgical site infection in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Primary Aim: To 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.
Hypothesis 1: The proportion of surgical site infections will be lower for patients treated with Supplemental Perioperative Oxygen.
Secondary Aim #1: Compare bacterial species and antimicrobial susceptibilities in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Hypothesis 2: In the patients who develop infections, the bacterial species and antimicrobial susceptibility profiles of those treated with Supplemental Perioperative Oxygen will be similar to those treated without Supplemental Perioperative Oxygen.
Secondary Aim #2: To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery.
Hypothesis 3: The previously developed RIOTS score will be highly predictive of infection risk.
Secondary Aim #3: Measure and compare resource utilization and cost associated with surgical site infection in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Hypothesis 4: Supplemental Perioperative Oxygen will be associated with lower resource utilization and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental Perioperative Oxygen (80% FiO2) | Experimental | Procedure: Supplemental Perioperative OxygenAfter intubation, patients in the Treatment Group will receive intraoperative inspired oxygen set at 80 percent (FiO2 of 0.80). Post-extubation, patients in the treatment arm will be placed on high flow non-re-breather mask at 15L/min for up to 2 hours postoperatively and then transitioned to nasal cannula, which will be weaned as tolerated. |
| Control (30% FiO2) | No intervention | –After intubation, patients in the control arm will receive typical standard of care intraoperative inspired oxygen of 30 percent (FiO2 of 0.30). Post-extubation, patients in the control arm of the study will be placed on a nasal cannula at 4L/min to maintain SaO2≥92% as determined by pulse oximetry. This will be maintained for up to 2 hours and then weaned as tolerated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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:
- 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:
- Ages 18 to 80 years
- Patients may have co-existing infection not at study fracture site, with or without antibiotic treatment.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental Perioperative OxygenPatients receiving perioperative oxygen will receive 80% FiO2 during surgery. | Procedure or surgery | Supplemental Perioperative Oxygen (80% FiO2) |
Primary outcome
Surgical Site Infection
Time frame: 26 weeks
The main outcome measure will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS).
3 secondary outcomes
Catalog and Compare Bacterial Species
Time frame: 26 weeks
Risk Factors for Infection
Time frame: 26 weeks
Resource Utilization and Cost
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renan Castillo, PhD study director
Johns Hopkins Bloomberg School of Public Health
Robert O'Toole, MD principal investigator
University of Maryland R Adams Cowley Shock Trauma Center
Anthony Carlini, MS study director
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental Perioperative Oxygen in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.