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Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery | Clinical Trials | Clareo Health

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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)

NCT01798810•Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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
+7 more criteria

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.

Locations (2)

Banner University Medical Center/The CORE Institute

Phoenix, Arizona, United States

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

May 1, 2019

Completion Date

June 30, 2022

Last Updated

July 29, 2022

Enrollment

1,000

ESTIMATED participants

Conditions

Post Operative Surgical Site Infection

Interventions

Supplemental Perioperative Oxygen

PROCEDURE