title: Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial.
abstract: BACKGROUND
  Open fractures with significant soft tissue injury are associated with high rates of complications, such as non-union, infection, chronic pain and disability. Complications often require further inpatient care, and in many cases, multiple operations and prolonged rehabilitation. Use of hyperbaric oxygen therapy as an adjunct to standard orthopaedic trauma care has the potential to reduce the complications of musculoskeletal injury and thus improve outcomes. Two previous randomised trials have suggested some positive effect, but neither functional measures nor long-term outcomes were reported.
  
  
  METHODS
  An international, multicentre, randomised, open-label, clinical trial. Patients with trauma with an acute open fracture of the tibia with severe soft tissue injury (Gustilo grade 3) and high risk of injury-related complications were recruited from participating major trauma hospitals with hyperbaric facilities. Patients were enrolled with the expectation of commencing 12 sessions of hyperbaric oxygen therapy within 48 h of injury. The primary outcome measure is the incidence of acute complications of the open fracture wound at 14 days. Other short-term outcome measures include amputation, need for fasciotomy, time until wound closure, breakdown of closed wounds, time until definitive orthopaedic fixation, number of operative procedures, intensive care stay and hospital stay. Long-term follow-up will continue for 2 years postinjury.
  
  
  BACKGROUND
  Ethics approval was given by The Alfred Health Human Ethics Committee (206/04) and the Monash University Human Research Ethics Committee (CF07/4208). Approval was also obtained from the institutional research ethics committee at each participating site. This study will make a significant contribution to the trauma literature and should answer the question of whether hyperbaric oxygen therapy can significantly improve outcomes in severe lower limb trauma. Collective study results will be published in international journals and presented at relevant conferences.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT00264511; Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12607000559415.
authors.affiliation: Hyperbaric Service, Department of Intensive Care & Hyperbaric Medicine, The Alfred Hospital, Melbourne, Victoria, Australia Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Ian L
authors.initials: IL
authors.lastname: Millar
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Rosemary A
authors.initials: RA
authors.lastname: McGinnes
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Owen
authors.initials: O
authors.lastname: Williamson
authors.affiliation: Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Folke
authors.initials: F
authors.lastname: Lind
authors.affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Karl-Åke
authors.initials: KÅ
authors.lastname: Jansson
authors.affiliation: Ostrava City Hospital, Ostrava, Czech Republic University of Ostrava, Ostrava-Zabreh, Czech Republic.
authors.forename: Michal
authors.initials: M
authors.lastname: Hajek
authors.affiliation: Royal Hobart Hospital, Hobart, Tasmania, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Smart
authors.affiliation: Hospital Pedro Hispano, Rua Dr. Eduardo Torres, Matosinhos, Portugal.
authors.forename: Tiago
authors.initials: T
authors.lastname: Fernandes
authors.affiliation: Department of Orthopaedic Surgery, The Alfred Hospital, Melbourne, Victoria, Australia.
authors.forename: Russell
authors.initials: R
authors.lastname: Miller
authors.affiliation: Department of Anaesthesia and Perioperative Medicine, The Alfred Hospital and Monash University, Melbourne, Victoria, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Myles
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Cameron
mesh_terms: D002985:Clinical Protocols; D005260:Female; D005597:Fractures, Open / Q000150:complications / Q000628:therapy*; D006801:Humans; D006931:Hyperbaric Oxygenation; D015994:Incidence; D008297:Male; D009336:Necrosis / Q000209:etiology / Q000628:therapy*; D017410:Practice Guidelines as Topic; D017695:Soft Tissue Injuries / Q000150:complications / Q000628:therapy*; D013978:Tibial Fractures / Q000150:complications / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing