Overview

This trial is active, not recruiting.

Conditions tibial fracture, soft tissue injury
Treatment hyperbaric oxygenation
Phase phase 2/phase 3
Sponsor Bayside Health
Collaborator Monash University
Start date February 2006
End date August 2014
Trial size 120 participants
Trial identifier NCT00264511, 206/04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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)
Patients randomised to this group will receive standard trauma care.

Primary Outcomes

Measure
Acute phase complication rate
time frame: 14 days post trauma

Secondary Outcomes

Measure
amputation rate
time frame: 3, 6, 9, 12, 18 and 24 months post trauma
late infection
time frame: 3, 6, 9, 12, 18 and 24 months post trauma
radiological union
time frame: 3, 6, 9, 12, 18 and 24 months post trauma
quality of life score
time frame: 3, 6, 9, 12, 18 and 24 months post trauma
functional outcome scores
time frame: 3, 6, 9, 12, 18 and 24 months post trauma

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Owen Williamson
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bayside Health.