补充围手术期氧气以减少高能骨折手术后手术部位感染（氧气研究）
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study).
作者信息
OʼToole Robert V, Joshi Manjari, Carlini Anthony R, Sikorski Robert A, Dagal Armagan, Murray Clinton K, Weaver Michael J, Paryavi Ebrahim, Stall Alec C, Scharfstein Daniel O, Agel Julie, Zadnik Mary, Bosse Michael J, Castillo Renan C
机构信息
*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.
出版信息
J Orthop Trauma. 2017 Apr;31 Suppl 1:S25-S31. doi: 10.1097/BOT.0000000000000803.
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.
围手术期补充氧气（SPO）疗法已被提议作为降低手术部位感染（SSI）风险的一种方法。目前关于降低SSI发生率和总体住院时间疗效的数据不一，而针对骨科创伤患者的数据较少。本研究是一项III期、双盲、前瞻性随机临床试验，主要目标是评估两种不同浓度的围手术期氧气对预防成人胫骨平台、pilon（胫骨远端关节面）或跟骨骨折且感染风险较高并接受钢板螺钉固定确定性治疗的患者发生SSI的疗效。患者按中心内1:1比例进行区组随机分组，分为治疗组（FiO2 80%）或对照组（FiO2 30%），并按每个研究损伤部位进行分层。该研究的次要目标是比较发生SSI患者的细菌种类和抗菌敏感性，验证先前开发的骨折手术后发生SSI的风险预测模型，并测量和比较两个研究组中与SSI相关的资源利用和成本。如果SPO被证明有效，它是一种低成本且易于获取的资源，可轻松推广至全国乃至全球的创伤中心。
Zotero 插件