Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hyperbaric Oxygen in Lower Leg Trauma

This study is ongoing, but not recruiting participants.
Sponsor:
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: August 25, 2014
Last verified: August 2014
  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: September 2016
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264511

Locations
United States, California
John Muir Clinical Research Center
Concord, California, United States, 94520
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
The Alfred
Melbourne, Victoria, Australia, 3004
Austria
Universitatsklinikum Graz
Graz, Austria
Chile
Hospital del Trabajador
Santiago, Chile
Czech Republic
City Hospital of Ostrava
Ostrava, Czech Republic, 728 80
Charles University Hospital, Pilsen
Pilsen, Czech Republic
India
Indraprastha Apollo Hospital
New Delhi, Sarita Vihar, India, 110076
Italy
Policlinico Umberto 1, University of Rome
Rome, Italy
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Portugal
Hospital Pedro Hispano
Senhora da Hora, Matosinhos, Portugal, 4454-509
Sweden
Karolinska Hospital
Stockholm, Sweden
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: August 25, 2014
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
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014