[abstract] HYPERBARIC OXYGEN IN LOWER LIMB TRAUMA (HOLLT): DESIGNING A RANDOMIZED CONTROLLED MULTI-CENTRE STUDY.

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[abstract] HYPERBARIC OXYGEN IN LOWER LIMB TRAUMA (HOLLT): DESIGNING A RANDOMIZED CONTROLLED MULTI-CENTRE STUDY.

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Title: [abstract] HYPERBARIC OXYGEN IN LOWER LIMB TRAUMA (HOLLT): DESIGNING A RANDOMIZED CONTROLLED MULTI-CENTRE STUDY.
Author: Millar, IL; Williamson, OD; Cameron, PA
Abstract: BACKGROUND: Crush injury and acute traumatic ischaemia are considered indications for HBO by many in the hyperbaric field. This is supported by animal models but most human research is uncontrolled and the randomized trial frequently quoted (Bouachour et al 1996) is difficult to interpret as there is no information on important outcomes such as fracture union, wound infection, osteomyelitis or long term disability. Given the practical difficulties of treating trauma patients with HBO it is hardly surprising that there is very little use of HBO for trauma. MATERIALS AND METHODS: We conducted a randomized double blinded pilot study of early HBO in open tibial fracture with severe soft tissue injury. 17 patients were enrolled over 18 months. We have used this experience to design an international multi-centre randomized controlled trial. RESULTS: HOLLT plans enrolment of 250 patients with Gustilo 3 open tibial fracture who will be randomized within 24 hours of injury to receive 12 HBO sessions over 8 days or not, in addition to normal trauma care. The study is “open label” based upon logistics, cost and avoidance of detriment from transporting control patients. Follow up will continue for two years. We have drawn upon Best Practice guidelines for clinical trials plus experts in trauma research and clinical trials design. Collaborating centers are necessarily limited to those with suitably designed and located chambers at trauma centers. Enrolments have commenced in Melbourne, Australia and ethics approvals have been received or are in process at a number of European and United States centers. CONCLUSIONS: Acute phase trauma research is difficult as a result of injury heterogeneity, acuity and the complex and busy logistics of early management. HBO in this environment can be difficult but is feasible with good facilities and experienced teams. We will welcome additional collaborators.
Description: Abstract of the Undersea and Hyperbaric Medical Society, Inc. Annual Scientific Meeting held June 14-16, 2007. Ritz-Carlton Kapalua Maui, Hawaii (http:www.uhms.org)
URI: http://archive.rubicon-foundation.org/5219
Date: 2007

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  • UHMS Meeting Abstracts
    This is a collection of the published abstracts from the Undersea and Hyperbaric Medical Society (UHMS) annual meetings.

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