Hyperbaric Oxygen in Lower Leg Trauma

Completed · Phase 2/Phase 3

Conditions studied: Tibial Fracture, Soft Tissue Injury

In brief

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.

Key facts

Study ID

NCT00264511

Run by

Bayside Health

People needed

120

Starts

2007-02-13

Expected to finish

2016-03-23

Last updated by the study team

2023-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• John Muir Clinical Research Center — Concord, California, United States
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• The Alfred — Melbourne, Victoria, Australia
• Universitatsklinikum Graz — Graz, Austria
• Hospital del Trabajador — Santiago, Chile
• City Hospital of Ostrava — Ostrava, Czechia
• Indraprastha Apollo Hospital — New Delhi, Sarita Vihar, India
• Policlinico Umberto 1, University of Rome — Rome, Italy
• Hospital Pedro Hispano — Senhora da Hora, Matosinhos, Portugal
• Karolinska Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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