Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial

Ian Lindsay Millar, Rosemary Anna McGinnes, Owen Douglas Williamson, Folke Lind, Karl-Ake Jansson, Michal Hajek, David Smart, Tiago Fernandes, Russell D Miller, Paul S Myles, Peter Cameron

Research output: Contribution to journalArticleOther

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.
Original languageEnglish
Article numbere008381
Pages (from-to)1 - 10
Number of pages10
JournalBMJ Open
Volume5
Issue number6
DOIs
Publication statusPublished - 2015

Cite this

Millar, Ian Lindsay ; McGinnes, Rosemary Anna ; Williamson, Owen Douglas ; Lind, Folke ; Jansson, Karl-Ake ; Hajek, Michal ; Smart, David ; Fernandes, Tiago ; Miller, Russell D ; Myles, Paul S ; Cameron, Peter. / Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial. In: BMJ Open. 2015 ; Vol. 5, No. 6. pp. 1 - 10.
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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.",
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Millar, IL, McGinnes, RA, Williamson, OD, Lind, F, Jansson, K-A, Hajek, M, Smart, D, Fernandes, T, Miller, RD, Myles, PS & Cameron, P 2015, 'Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial' BMJ Open, vol. 5, no. 6, e008381, pp. 1 - 10. https://doi.org/10.1136/bmjopen-2015-008381

Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial. / Millar, Ian Lindsay; McGinnes, Rosemary Anna; Williamson, Owen Douglas; Lind, Folke; Jansson, Karl-Ake; Hajek, Michal; Smart, David; Fernandes, Tiago; Miller, Russell D; Myles, Paul S; Cameron, Peter.

In: BMJ Open, Vol. 5, No. 6, e008381, 2015, p. 1 - 10.

Research output: Contribution to journalArticleOther

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T1 - Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial

AU - Millar, Ian Lindsay

AU - McGinnes, Rosemary Anna

AU - Williamson, Owen Douglas

AU - Lind, Folke

AU - Jansson, Karl-Ake

AU - Hajek, Michal

AU - Smart, David

AU - Fernandes, Tiago

AU - Miller, Russell D

AU - Myles, Paul S

AU - Cameron, Peter

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

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