Status:
COMPLETED
Hyperbaric Oxygen in Lower Leg Trauma
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
Monash University
National Health and Medical Research Council, Australia
Conditions:
Tibial Fracture
Soft Tissue Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ra...
Detailed Description
A randomised controlled trial was undertaken on using hyperbaric oxygen in addition to standard orthopaedic trauma care in severe lower leg injury, defined as an open tibial fracture with severe soft ...
Eligibility Criteria
Inclusion
- 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
- Significant head injury
- Injuries incompatible with HBO
- resuscitation requirements incompatible with HBO
- follow up not possible
- hyperbaric contra indications
Key Trial Info
Start Date :
February 13 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00264511
Start Date
February 13 2007
End Date
March 23 2016
Last Update
September 5 2023
Active Locations (10)
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1
John Muir Clinical Research Center
Concord, California, United States, 94520
2
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
3
The Alfred
Melbourne, Victoria, Australia, 3004
4
Universitatsklinikum Graz
Graz, Austria