New Orleans, LA – Orthopaedics faculty at LSU Health New Orleans participated in a study comparing two antisepsis aqueous solutions in reducing the risk of infection in patients requiring surgery for open fractures. In the largest known randomized-controlled trial, the research team found that contrary to current international recommendations, chlorhexidine gluconate was not superior to povidone-iodine in an alcohol or aqueous solution in preventing surgical site infection. The results suggesting health care practitioners can select either aqueous-based antisepsis solution when treating open fractures on the basis of solution availability, patient contraindications, or product cost are published in The Lancet, available here.
Robert Zura, MD, Professor and Head of Orthopaedics, and Jessica Rivera, MD, PhD, Associate Professor of Orthopaedics, at LSU Health New Orleans School of Medicine, are also co-authors on the paper.
“I am proud of Dr. Rivera’s and LSU Health New Orleans’ contributions to this landmark study published in such a prestigious journal,” says Dr. Zura.
The authors highlight WHO estimates of millions of patients worldwide each year who have surgical site infections. The inherent risk of using fracture fixation in a contaminated or dirty wound is realized in about 10% of open fractures developing surgical site infections. Orthopaedic surgical procedures have the highest infection rate, greater than 20% for severe open tibia shaft fractures.
Previous reviews of general surgery, obstetrics and gynecology trials suggested the superiority of chlorhexidine over iodine. The Aqueous-PREP multiple-period, cluster-randomized,
crossover trial included 14 hospitals in Canada, Spain and the United States and 1,638 adults who underwent surgery for an open extremity fracture. It found that the odds of surgical site infection or unplanned fracture-related reoperations did not differ between patients assigned to receive skin antisepsis with aqueous 10% povidone or aqueous 4% chlorhexidine gluconate. The authors wrote, “Our findings contrast the superiority of chlorhexidine in alcohol that has been shown in clean or clean-contaminated surgery.”
The authors note their findings could have particular relevance to low- and middle-income countries, where both antiseptic solutions might not be readily available or procuring both
products is unnecessarily costly.
They conclude, “Our findings are not only relevant to the management of open fractures but might also be applicable to the surgical treatment of other traumatic wounds.”
This study was funded by the US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, and the PSI Foundation.
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LSU Health Sciences Center New Orleans educates Louisiana's health care professionals. The state's flagship health sciences university, LSU Health New Orleans includes a School of Medicine with campuses in Baton Rouge and Lafayette, the state's only School of Dentistry, Louisiana's only public School of Public Health, and Schools of Allied Health Professions, Nursing, and Graduate Studies. LSU Health New Orleans faculty take care of patients in public and private hospitals and clinics throughout the region. In the vanguard of biosciences research in a number of areas in a worldwide arena, the LSU Health New Orleans research enterprise generates jobs and enormous economic impact. LSU Health New Orleans faculty have made lifesaving discoveries and continue to work to prevent, advance treatment, or cure disease. To learn more, visit http://www.lsuhsc.edu, http://www.twitter.com/LSUHealthNO, or http://www.facebook.com/LSUHSC.
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Journal
The Lancet
Method of Research
Randomized controlled/clinical trial
Subject of Research
People
Article Title
Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial
Article Publication Date
14-Oct-2022
COI Statement
GPS reports site payments and principal investigator support for the present manuscript from the US Department of Defense and editorial or governing board for the Journal of Orthopaedic Trauma, and is a board or committee member for the Orthopaedic Trauma Association, outside of the submitted work. SS reports payments made to the institution from the US Department of Defense, Physicians Services, and McMaster Surgical Associates for the present manuscript. JLW reports a stipend from the PREP-IT Study for the submitted work, support for attending site initiation visits and the PCORI conference, and participation on a data safety monitoring board or advisory board at METRC, John Hopkins Bloomberg School of Public Health, and the Institutional Review Board at the University of Maryland. ADH reports a grant (contract number W81XWH-17-1-0702) to his institution from the US Department of Defense for the present manuscript. WO reports payment from AO North America for an educational event, lawyer fees for patients and expert opinion, American Task Force Commission from AO International, and is a board or committee member for the Southeastern Fracture Consortium, outside of the submitted work. SJW reports grants from AO North America, consulting fees for implant development from Synthes, and payment or honoraria for educational events from Smith and Nephew and Stryker Globus, outside of the submitted work. JLG reports payments to their institution for effort and coordinator support for study activities from PCORI and McMaster University for the present manuscript. SNP reports grant for study unrelated to this work from the Orthopaedic Trauma Association and honoraria for work unrelated to this manuscript from Skeletal Dynamics. RVO reports support for the present manuscript from the US Department of Defense, Department of Defense funding regarding orthopaedic surgery and infection (TOBRA, VANCO, OXYGEN grants), as well as PCORI regarding venous thromboembolism, royalties from Lincotek, consulting fees from Stryker, and stock options from Imagen, outside of the submitted work. MJP reports consulting fees for Orthopaediatrics on their tibial nail project, outside of the submitted work. JL reports royalties or licences from Stryker, consulting fees from Stryker, and chair of the Orthopaedic Trauma Association PR committee, AONATEC, outside of the submitted work. MTM reports consulting fees from Stryker, ITS, and Acumed, board of directors for the Orthopaedic Trauma Association, and deputy editor for the Journal of Orthopaedic Trauma, outside of the submitted work. MM reports payments made to his institution from the US Department of Defense, US patents for implants using ultrasonic backscatter for sensing electrical impedance of tissue and for a quantitative tool using impedance spectroscopy to monitor fracture healing, participation in the classification committee chair for the Orthopaedic Trauma Association, and an exchange-traded fund investment, outside of the submitted work. NNO reports support for the present manuscript to his institution from the US Department of Defense. GJDR reports research payments made to his institution from the AO Foundation, royalty payments unrelated to manuscript or research from Wright-Tornier, travel and meeting expenses from the AO Foundation, multiple patents held unrelated to manuscript or research from Intellectual Ventures, member of the board of councillors of the American Academy of Orthopaedic Surgeons, and minority shareholder for Mergenet Medical and the Orthopaedic Implant Company, outside of the submitted work. RDZ reports consulting fees from Bioventus, Osteocentric, and Stryker, payment for being a consultant speaker from Bioventus, and is a board member for the Kuntsher Society, outside of the submitted work. JTP reports grants or contracts from AO North America for the Young Investigator Research Development Award, invited speaker for AO Trauma North America Internet Live Series: Orthopaedic Trauma Journal Club Session (topic: femoral neck), and support for attending meetings or travel from AO North America for the Young Investigator Research Development Award, outside of the submitted work. DM reports a stipend from the PREP-IT Study for the submitted work and support for attending the PCORI conference twice. ILG reports research grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Institutes of Health and the Department of Defense Peer Reviewed Orthopaedic Research Program Clinical Translational Research Award, consulting and teaching fees from Stryker, teaching payments from AO North America, and support for attending meetings from Institutional CME, outside of the submitted work. JCR reports grant awards from the US Department of Defense and board or committee member for the Limb Lengthening and Reconstruction Society, Orthopaedic Research Society, and American Academy of Orthopaedic Surgery, outside of the submitted work. PJD reports grant funding from Abbott Diagnostics, Roche Diagnostics, and Siemens, consulting fees from Trimedic, payment or honoraria for presentations from Bayer and Roche, member of advisory boards for Bayer and Quidel Canada, and receipt of monitor devices from CloudDX and Philips Healthcare, outside of the submitted work. MB reports payments made to the institution for the present manuscript from the Canadian Institutes of Health Research, US Department of Defense, McMaster University Surgical Associates, and Physician Services, payments made to his institution from the National Institutes of Health and Michael G DeGroote Institute for Pain Research and Care, and is an advisory board member for the International Society of Orthopaedic Surgery and Traumatology, outside of the submitted work. All other authors declare no competing interests.