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Hyperbaric Oxygen in Lower Leg Trauma - Article


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Clinical Trial: Hyperbaric Oxygen in Lower Leg Trauma

This study is not yet open for patient recruitment.
Verified by Bayside Health December 2005

Sponsored by: Bayside Health
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00264511

Purpose

Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe lower limb trauma. We propose to investigate this hypothesis by conducting an International multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.
Condition Intervention Phase
Tibial Fracture
Soft Tissue Injury
  Procedure: Hyperbaric Oxygenation
 Phase II
Phase III

MedlinePlus related topics:  Leg Injuries and Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title: Does Hyperbaric Oxygen Reduce Complications and Improve Outcomes After Open Tibial Fractures With Severe Soft Tissue Injury? An International Multi-Centre Randomized Controlled Trial.

Further study details as provided by Bayside Health:
Primary Outcomes: Acute phase complication rate; soft tissue necrosis; acute infection; compartment syndrome
Secondary Outcomes: amputation rate; late infection; radiological union; quality of life score; functional outcome scores
Expected Total Enrollment:  250

Study start: February 2006;  Expected completion: December 2010
Last follow-up: June 2010;  Data entry closure: August 2010

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Acute fracture of the tibia with significant soft tissue injury of Gustilo Grade 3
  • Ability to commence HBO therapy within 24 hours
  • Valid consent

Exclusion Criteria:

  • Significant head injury
  • Injuries incompatible with HBO
  • resuscitation requirements incompatible with HBO
  • follow up not possible
  • hyperbaric contra indications

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00264511

Ian L Millar, MBBS      +61 3 9276 2269    I.millar@alfred.org.au
Cate M Venturoni, RN      +61 3 9276 2269    c.venturoni@alfred.org.au

Australia, Victoria
      The Alfred, Melbourne,  Victoria,  3004,  Australia
Ian L Millar, MBBS,  Principal Investigator

Austria
      Universitatsklinikum Graz, Graz,  Austria
Beatrice Ratzenhofer-Komenda
Rainer Gumpert, MD,  Principal Investigator
Freyja Smolle-Juttner,  Principal Investigator
Beatrice Ratzenhofer-Komenda,  Principal Investigator

Germany, Bayern
      BG Unfallklinik Murnau, Murnau,  Bayern,  Germany
Armin Kemmer

Sweden
      Karolinska Hospital, Stockholm,  Sweden
Folke Lind, MD, PhD

Study chairs or principal investigators

Ian L Millar, MBBS,  Study Chair,  Bayside Health   
Owen Williamson,  Principal Investigator,  Monash University   
Peter Cameron,  Principal Investigator,  Monash University   

More Information

Publications

Bouachour G, Cronier P, Gouello JP, Toulemonde JL, Talha A, Alquier P. Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial. J Trauma. 1996 Aug;41(2):333-9.

Garcia-Covarrubias L, McSwain NE Jr, Van Meter K, Bell RM. Adjuvant hyperbaric oxygen therapy in the management of crush injury and traumatic ischemia: an evidence-based approach. Am Surg. 2005 Feb;71(2):144-51. Review.

Study ID Numbers:  206/04
Last Updated:  December 12, 2005
Record first received:  December 12, 2005
ClinicalTrials.gov Identifier:  NCT00264511
Health Authority: Australia: National Health and Medical Research Council
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006


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