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

NCT ID: NCT01798810

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2022-06-30

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.

Conditions

Post Operative Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Supplemental Perioperative Oxygen

Intervention Type: PROCEDURE

Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supplemental Perioperative Oxygen

Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Major Extremity Trauma Research Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renan Castillo, PhD

Role: STUDY_DIRECTOR

Johns Hopkins Bloomberg School of Public Health

Robert O'Toole, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland R Adams Cowley Shock Trauma Center

Anthony Carlini, MS

Role: STUDY_DIRECTOR

Johns Hopkins Bloomberg School of Public Health

Locations

Banner University Medical Center/The CORE Institute

Phoenix, Arizona, United States

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

W81XWH-12-1-0588

Identifier Type: -

Identifier Source: org_study_id