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Hyperbaric Oxygen in Lower Leg Trauma

NCT00264511 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-05

No results posted yet for this study

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 randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.

Conditions

  • Tibial Fracture
  • Soft Tissue Injury

Interventions

OTHER

Hyperbaric Oxygen Treatment

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.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Ian L Millar, MBBS · Bayside Health

  • Owen Williamson · Monash University

  • Peter Cameron · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-13
Primary Completion
2014-08-18
Completion
2016-03-23

Countries

  • United States
  • Australia
  • Austria
  • Chile
  • Czechia
  • India
  • Italy
  • Portugal
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00264511 on ClinicalTrials.gov