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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

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

NCT ID

NCT01798810

First Posted

February 18, 2013

Last Updated

July 27, 2022

Sponsor

Major Extremity Trauma Research Consortium

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

Arm Title

Control (30% FiO2)

Arm Type

No Intervention

Arm Description

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

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Catalog and Compare Bacterial Species

Description

Time Frame

26 weeks

Title

Risk Factors for Infection

Description

Time Frame

26 weeks

Title

Resource Utilization and Cost

Description

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

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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