Hyperbaric Oxygen in Lower Leg Trauma
This study is currently recruiting participants.
Verified March 2013 by Bayside Health
Sponsor:
Bayside Health
Collaborators:
Monash University
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00264511
First received: December 12, 2005
Last updated: March 13, 2013
Last verified: March 2013
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Bayside Health:
Primary Outcome Measures:
- Acute phase complication rate [ Time Frame: 14 days post trauma ] [ Designated as safety issue: No ]The primary outcome measure will be the incidence of acute complications after injury. This is a composite measure we define as the occurrence within two weeks of trauma of one or both of: significant soft tissue necrosis developing after the initial surgery or significant wound infection.
Secondary Outcome Measures:
- amputation rate [ Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma ] [ Designated as safety issue: No ]
- late infection [ Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma ] [ Designated as safety issue: No ]
- radiological union [ Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma ] [ Designated as safety issue: No ]
- quality of life score [ Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma ] [ Designated as safety issue: No ]
- functional outcome scores [ Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hyperbaric oxygenation
Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
|
Procedure: Hyperbaric Oxygenation
Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
|
|
No Intervention: No hyperbaric oxygenation
Patients randomised to this group will receive standard trauma care.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute fracture of the tibia with significant soft tissue injury of Gustilo Grade 3
- Enrolment within 48 hours of injury with expectation of commencement of HBO therapy within 48 hours of injury
- Valid consent
Exclusion Criteria:
- Significant head injury
- Injuries incompatible with HBO
- resuscitation requirements incompatible with HBO
- follow up not possible
- hyperbaric contra indications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264511
Contacts
| Contact: Ian L Millar, MBBS | +61 3 9276 2269 | I.millar@alfred.org.au |
| Contact: Project Coordinator | +61 3 9903 0926 | HOLLT@monash.edu |
Locations
| United States, California | |
| John Muir Clinical Research Center | Not yet recruiting |
| Concord, California, United States, 94520 | |
| Contact: Peter C Benson, MD MPH pcbenson@gmail.com | |
| Principal Investigator: Peter C Benson, MD MPH | |
| Australia, Tasmania | |
| Royal Hobart Hospital | Recruiting |
| Hobart, Tasmania, Australia, 7000 | |
| Contact: David Smart, MBBS, MD +61 3 6222 8322 david.smart@dhhs.tas.gov.au | |
| Principal Investigator: David Smart, MBBS, MD | |
| Australia, Victoria | |
| The Alfred | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Ian L Millar, MBBS +61 3 9076 2269 I.millar@alfred.org.au | |
| Principal Investigator: Ian L Millar, MBBS | |
| Austria | |
| Universitatsklinikum Graz | Active, not recruiting |
| Graz, Austria | |
| Canada, British Columbia | |
| Vancouver General Hospital | Withdrawn |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Czech Republic | |
| City Hospital of Ostrava | Recruiting |
| Ostrava, Czech Republic, 728 80 | |
| Contact: Michal Hajek +420 596 192 483 michal.hajek@mnof.cz | |
| Principal Investigator: Michal Hajek | |
| Charles University Hospital, Pilsen | Recruiting |
| Pilsen, Czech Republic | |
| Contact: Jiri Ruzicka Jiri.Ruzicka@lfp.cuni.cz | |
| Principal Investigator: Jiri Ruzicka | |
| India | |
| Indraprastha Apollo Hospital | Recruiting |
| New Delhi, Sarita Vihar, India, 110076 | |
| Contact: Tarun Sahni +91 11 26925858 hyperbarics@apollohospitals.com | |
| Principal Investigator: Tarun Sahni | |
| Italy | |
| Policlinico Umberto 1, University of Rome | Recruiting |
| Rome, Italy | |
| Contact: Monica Rocco, MD Monica.Rocco@uniroma1.it | |
| Principal Investigator: Monica Rocco, MD | |
| Norway | |
| Ullevål University Hospital | Active, not recruiting |
| Oslo, Norway, 0407 | |
| Portugal | |
| Hospital Pedro Hispano | Recruiting |
| Senhora da Hora, Matosinhos, Portugal, 4454-509 | |
| Contact: Tiago Fernandes, MD, DESA 351 229 39 1876 Tiago.Fernandes@ulsm.min-saude.pt | |
| Principal Investigator: Tiago Fernandes, MD, DESA | |
| Sweden | |
| Karolinska Hospital | Recruiting |
| Stockholm, Sweden | |
| Contact: Folke Lind, MD, PhD folke.lind@karolinska.se | |
| Principal Investigator: Folke Lind, MD, PhD | |
Sponsors and Collaborators
Bayside Health
Monash University
National Health and Medical Research Council, Australia
Investigators
| Study Chair: | Ian L Millar, MBBS | Bayside Health |
| Principal Investigator: | Owen Williamson | Monash University |
| Principal Investigator: | Peter Cameron | Monash University |
More Information
Additional Information:
Publications:
| Responsible Party: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00264511 History of Changes |
| Other Study ID Numbers: | 206/04 |
| Study First Received: | December 12, 2005 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Bayside Health:
|
Hyperbaric oxygen Crush injury Tibial fracture Gustillo 3 |
soft tissue injury complications outcomes randomised controlled trial |
Additional relevant MeSH terms:
|
Fractures, Bone Soft Tissue Injuries Tibial Fractures Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 16, 2013