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| 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 |
| 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. |
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | June 2010 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ian L Millar, MBBS | +61 3 9276 2269 | I.millar@alfred.org.au |
| Contact: Project Coordinator | +61 3 9903 0926 | HOLLT@med.monash.edu.au |
| United States, Arizona | |
| Scottsdale Healthcare Osborn | Recruiting |
| Phoenix, Arizona, United States, 85251 | |
| Contact: Dennis E Weiland, MD | |
| Contact: Brandy Sevarlic, RN, MSN | |
| Principal Investigator: Dennis E Weiland, MD | |
| United States, Connecticut | |
| The Hartford Hospital | Not yet recruiting |
| Hartford, Connecticut, United States | |
| Contact: George Perdrizet, MD,PhD,FACS | |
| Principal Investigator: George Perdrizet, MD,PhD,FACS | |
| Australia, Victoria | |
| The Alfred | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Ian L Millar, MBBS | |
| Contact: Cate Venturoni, RN | |
| Principal Investigator: Ian L Millar, MBBS | |
| Austria | |
| Universitatsklinikum Graz | Recruiting |
| Graz, Austria | |
| Contact: Beatrice Ratzenhofer-Komenda, MD | |
| Principal Investigator: Franz Seibert, MD | |
| Principal Investigator: Freyja Smolle-Juttner | |
| Principal Investigator: Beatrice Ratzenhofer-Komenda, MD | |
| Czech Republic | |
| Charles University Hospital, Pilsen | Recruiting |
| Pilsen, Czech Republic | |
| Contact: Jiri Ruzicka | |
| Principal Investigator: Jiri Ruzicka | |
| Germany, Bayern | |
| BG Unfallklinik Murnau | Not yet recruiting |
| Murnau, Bayern, Germany | |
| Contact: Armin Kemmer | |
| Principal Investigator: Armin Kemmer | |
| Principal Investigator: Holger Schoeppenthau, MD | |
| Italy | |
| Policlinico Umberto 1, University of Rome | Recruiting |
| Rome, Italy | |
| Contact: Monica Rocco, MD | |
| Principal Investigator: Monica Rocco, MD | |
| Sweden | |
| Karolinska Hospital | Recruiting |
| Stockholm, Sweden | |
| Contact: Folke Lind, MD, PhD | |
| Principal Investigator: Folke Lind, MD, PhD | |
| Study Chair: | Ian L Millar, MBBS | Bayside Health |
| Principal Investigator: | Owen Williamson | Monash University |
| Principal Investigator: | Peter Cameron | Monash University |
More Information
| Study ID Numbers: | 206/04 |
| Study First Received: | December 12, 2005 |
| Last Updated: | April 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00264511 |
| Health Authority: | Australia: National Health and Medical Research Council |
|
Hyperbaric oxygen Crush injury Tibial fracture Gustillo 3 |
soft tissue injury complications outcomes randomised controlled trial |
|
Soft Tissue Injuries Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Leg Injuries Tibial Fractures |
