Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
Condition: Post Operative Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional

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.
    

Intervention name(s): Supplemental Perioperative Oxygen
Intervention type(s): Procedure
Intervention description(s): Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surgical Site Infection Risk Prediction; Bacterial species type and antibacterial sensitivities; Resource Utilization and Cost