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Surgery
Protocol
Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial
  1. Ian L Millar1,2,
  2. Rosemary A McGinnes2,
  3. Owen Williamson2,
  4. Folke Lind3,
  5. Karl-Åke Jansson4,
  6. Michal Hajek5,6,
  7. David Smart7,
  8. Tiago Fernandes8,
  9. Russell Miller9,
  10. Paul Myles10,
  11. Peter Cameron2
  1. 1Hyperbaric Service, Department of Intensive Care & Hyperbaric Medicine, The Alfred Hospital, Melbourne, Victoria, Australia
  2. 2Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  3. 3Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden
  4. 4Department of Molecular Medicine and Surgery, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden
  5. 5Ostrava City Hospital, Ostrava, Czech Republic
  6. 6University of Ostrava, Ostrava-Zabreh, Czech Republic
  7. 7Royal Hobart Hospital, Hobart, Tasmania, Australia
  8. 8Hospital Pedro Hispano, Rua Dr. Eduardo Torres, Matosinhos, Portugal
  9. 9Department of Orthopaedic Surgery, The Alfred Hospital, Melbourne, Victoria, Australia
  10. 10Department of Anaesthesia and Perioperative Medicine, The Alfred Hospital and Monash University, Melbourne, Victoria, Australia
  1. Correspondence to Dr Ian L Millar; i.millar{at}alfred.org.au

Abstract

Introduction 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 and analysis 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.

Ethics and dissemination 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.

Trial registration number Clinicaltrials.gov: NCT00264511; Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12607000559415.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2015-008381

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