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

Primary Purpose

Post Operative Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supplemental Perioperative Oxygen
Sponsored by
Major Extremity Trauma Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Surgical Site Infection focused on measuring Surgical Site Infection Risk Prediction, Bacterial species type and antibacterial sensitivities, Resource Utilization and Cost

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner University Medical Center/The CORE Institute
  • University of Maryland R Adams Cowley Shock Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supplemental Perioperative Oxygen (80% FiO2)

Control (30% FiO2)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 18, 2013
Last Updated
July 27, 2022
Sponsor
Major Extremity Trauma Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT01798810
Brief Title
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
Acronym
OXYGEN
Official Title
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Major Extremity Trauma Research Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Surgical Site Infection
Keywords
Surgical Site Infection Risk Prediction, Bacterial species type and antibacterial sensitivities, Resource Utilization and Cost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplemental Perioperative Oxygen (80% FiO2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (30% FiO2)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supplemental Perioperative Oxygen
Intervention Description
Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
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).
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Catalog and Compare Bacterial Species
Description
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.
Time Frame
26 weeks
Title
Risk Factors for Infection
Description
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.
Time Frame
26 weeks
Title
Resource Utilization and Cost
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renan Castillo, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert O'Toole, MD
Organizational Affiliation
University of Maryland R Adams Cowley Shock Trauma Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Carlini, MS
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Banner University Medical Center/The CORE Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
University of Maryland R Adams Cowley Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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

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