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Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798810
Recruitment Status : Active, not recruiting
First Posted : February 26, 2013
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

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 Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.

Condition or disease Intervention/treatment Phase
Post Operative Surgical Site Infection Procedure: Supplemental Perioperative Oxygen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
Study Start Date : June 2013
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Supplemental Perioperative Oxygen (80% FiO2)
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.
Procedure: Supplemental Perioperative Oxygen
Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.

No Intervention: Control (30% FiO2)
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.



Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Catalog and Compare Bacterial Species [ Time Frame: 26 weeks ]

    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.

  2. Risk Factors for Infection [ Time Frame: 26 weeks ]

    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.


  3. Resource Utilization and Cost [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798810


Locations
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United States, Arizona
Banner University Medical Center/The CORE Institute
Phoenix, Arizona, United States, 85023
United States, Maryland
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Investigators
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Study Director: Renan Castillo, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Robert O'Toole, MD University of Maryland R Adams Cowley Shock Trauma Center
Study Director: Anthony Carlini, MS Johns Hopkins Bloomberg School of Public Health
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Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT01798810    
Other Study ID Numbers: W81XWH-12-1-0588
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Keywords provided by Major Extremity Trauma Research Consortium:
Surgical Site Infection Risk Prediction
Bacterial species type and antibacterial sensitivities
Resource Utilization and Cost
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes