Millar

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Protocol for a trial underway into the adjunctive treatment of lower limb trauma with hyperbaric oxygenation

No data yet published

Citation/s:

1. Millar IL, Williamson OD, Cameron PA. Hyperbaric oxygen in lower limb trauma (HOLLT): Designing a randomised controlled multi-centre study. Undersea and Hyperbaric Medicine 2007; 34(4):299. Lead author's name and fax:Ian Millar: [i.millar@alfred.org.au]

2. Millar IL, McGinnes RA, Williamson O, Lind F, Jansson A-K, Hajek M, Smart D, Fernandes T, Miller RMyels P, Cameron P. Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial. BMJ Open 2015;5:e008381.doi:10.1136/bmjopen-2015-008381


Lead author's name and fax:Ian Millar: [i.millar@alfred.org.au]

Three-part Clinical Question:For patients with crush injury and traumatic ischaemia to the lower limb, does the addition of hyperbaric oxygen therapy result in any improvement in morbidity or mortality?

​​​​​​​Search Terms:'Crush injury, compartment syndrome, ‍fracture‍

​​​​​​​The Study: Non-blinded randomised controlled trial with intention-to-treat.

​​​​​​​The Study Patients:Trauma patients with open tibial fractures with associated severe soft tissue injury (Gustilo grade 3) and enrolled within 48 hours of injury. Initial sample size of 250 patients was reduced to 120 after data review board determined a higher than expected event rate for primary outcome that planned.

Control group'Standard surgical and nursing management

Experimental groupAs above plus 12 sessions of HBOT over 8 days and commencing within 12 hours of injury

 

Outcomes:

Primary: Wound complications - significant wound necrosis and/or wound infection as judged by an independent observer at 14 days. Secondary: Fasciotomy, bone cover, skin closure, wound breakdown, LOS. Later outcomes: Clinical and radiological healing out to 24 months.

​​​​​​​Comments:

1. Trial has completed recruitment and full account is under way. Initial problems with recruitment resulted in increasing time to recruitment form 24 hours after injury to 48 hours.

2. Computerized block randomisation schedule,

​​​​​​​Appraised by:Mike Bennett Sydney;Tuesday, 3rd January 2017

Email: [m.bennett@unsw.edu.au]

​​​​​​​Kill or Update By:December 2023

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