NCT01798810

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Supplemental Perioperative Oxygen	Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.

Timeline

• Start date: 2013-06-01
• Primary completion: 2019-05-01
• Completion: 2022-06-30
• First posted: 2013-02-26
• Last updated: 2022-07-29

Locations

2 sites across 1 country: United States