Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study).
Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation. Patients are block randomized (within center) in a 1:1 ratio to either treatment group (FiO2 80%) or control group (FiO2 30%) and stratified by each study injury location. Secondary objectives of the study are to compare species and antibacterial sensitivities of the bacteria in patients who develop SSIs, to validate a previously developed risk prediction model for the development of SSI after fracture surgery, and to measure and compare resource utilization and cost associated with SSI in the 2 study groups. SPO is a low cost and readily available resource that could be easily disseminated to trauma centers across the country and the world if proved to be effective.
*Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD; †Division of Infectious Diseases, R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, MD; ‡Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD; ‖Harborview Medical Center, University of Washington, Seattle, WA; ¶U.S. Army, Uniformed Services University of the Health Sciences, San Antonio Military Medical Center, Infectious Disease Service, San Antonio, TX; **Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA; ††Department of Orthopedics, Baylor College of Medicine, San Antonio, TX; ‡‡Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §§Occupational Therapy Program, University of St. Augustine for Health Sciences, Austin, TX; and ‖‖Department of Orthopaedic Surgery, Carolinas Medical Center, Charlotte, NC.
Robert V
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OʼToole
Manjari
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Joshi
Anthony R
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Carlini
Robert A
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Sikorski
Armagan
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Dagal
Clinton K
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Murray
Michael J
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Weaver
Ebrahim
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Paryavi
Alec C
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Stall
Daniel O
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Scharfstein
Julie
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Agel
Mary
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Zadnik
Michael J
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Bosse
Renan C
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Castillo
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001424:Bacterial Infections / Q000191:economics* / Q000453:epidemiology / Q000517:prevention & control; D003131:Combined Modality Therapy / Q000191:economics / Q000379:methods / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D005260:Female; D050723:Fractures, Bone / Q000191:economics* / Q000453:epidemiology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000008:administration & dosage; D010102:Oxygen Inhalation Therapy / Q000191:economics* / Q000379:methods* / Q000706:statistics & numerical data; D019990:Perioperative Care / Q000191:economics / Q000379:methods / Q000706:statistics & numerical data; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000191:economics* / Q000517:prevention & control*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D010100:Oxygen