Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multi-centre randomised clinical trial
Authors:   Department of Intensive Care and Hyperbaric Medicine, Alfred Health, Melbourne, Victoria, Australia, Millar Ian L ,   Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia, Lind Folke G ,   Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden, Jansson Karl-Ake ,   Department of Molecular Medicine and Surgery, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden, Hajek Michal ,   Centre of Hyperbaric Medicine, Ostrava City Hospital, Ostrava, Czech Republic,   Department of Biomedical Sciences, Faculty of Medicine, University of Ostrava, Ostrava-Zabreh, Czech Republic, Smart David R ,   Department of Diving and Hyperbaric Medicine, Royal Hobart Hospital, Hobart, Tasmania, Australia,   School of Medicine, University of Tasmania, Tasmania, Australia, Fernandes Tiago D ,   Hyperbaric Medicine Unit, Department of Anesthesia, Hospital Pedro Hispano, Matosinhos, Portugal, McGinnes Rosemary A ,   Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia, Williamson Owen D ,   Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia, Miller Russell K ,   Department of Orthopaedic Surgery, Alfred Health, Melbourne, Victoria, Australia, Martin Catherine A ,   Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia, Gabbe Belinda J ,   Prehospital, Emergency and Trauma Research Unit, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia,   Health Data Research UK, Swansea University, Swansea, United Kingdom, Myles Paul S ,   Department of Anaesthesiology and Perioperative Medicine, Alfred Health and Monash University, Melbourne, Victoria, Australia, Cameron Peter A ,   Prehospital, Emergency and Trauma Research Unit, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Published: September 2022

Introduction: Hyperbaric oxygen treatment (HBOT) is sometimes used in the management of open fractures and severe soft tissue crush injury, aiming to reduce complications and improve outcomes. Methods: Patients with open tibial fractures were randomly assigned within 48 hours of injury to receive standard trauma care or standard care plus 12 sessions of HBOT. The primary outcome was the incidence of necrosis or infection or both occurring within 14 days of injury. Results: One-hundred and twenty patients were enrolled. Intention to treat primary outcome occurred in 25/58 HBOT assigned patients and 34/59 controls (43% vs 58%, odds ratio (OR) 0.55, 95% confidence interval (CI) 0.25 to 1.18, P = 0.12). Tissue necrosis occurred in 29% of HBOT patients and 53% of controls (OR 0.35, 95% CI 0.16 to 0.78, P = 0.01). There were fewer late complications in patients receiving HBOT (6/53 vs 18/52, OR 0.22, 95% CI 0.08 to 0.64, P = 0.007) including delayed fracture union (5/53 vs 13/52, OR 0.31, 95% CI 0.10 to 0.95, P = 0.04). Quality of life measures at one and two years were superior in HBOT patients. The mean score difference in short form 36 was 2.90, 95% CI 1.03 to 4.77, P = 0.002, in the short musculoskeletal function assessment (SMFA) was 2.54, 95% CI 0.62 to 4.46, P = 0.01; and in SMFA daily activities was 19.51, 95% CI 0.06 to 21.08, P = 0.05. Conclusions: In severe lower limb trauma, early HBOT reduces tissue necrosis and the likelihood of long-term complications, and improves functional outcomes. Future research should focus on optimal dosage and whether HBOT has benefits for other injury types.