Hyperbaric Oxygen in Lower Limb Trauma

Phase 2

Completed

• Conditions: Fracture; Outcomes; Trauma; Complications of Injury; Acute open fractures of the tibia with associated severe soft tissue injury; Injuries and Accidents - Fractures; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12607000559415
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

* Subjects will have suffered an acute open fracture of the tibia with severe soft tissue injury and a high risk of injury related complications as judged by an assessment of the injury, the injury mechanism(s) and the host status (generally aimed to identify Gustilo Grade 3 injury). Digital photography and radiology will be used as an audit tool and to confirm subtypes of severity grading.
* Minimum age 18 years (or older where collaborators local consent procedures require this)
* Enrolment within 48 hours of injury with expectation of commencement of HBO therapy within 48 hours of injury. Note: subject can remain in study if HBO unexpectedly delayed after enrolment
* Permission to enrol of patient granted by trauma team managing patient
* Consent from patient or next of kin

Exclusion Criteria

* Other injuries, instability or resuscitation / intensive care requirements judged by the trauma surgeon or intensive care specialist to be incompatible with safe hyperbaric oxygen therapy

* Malignancy, renal failure, diabetes, cardiac failure or other serious medical condition where the severity of the condition is such that the patient is not expected to survive for the follow up period or where it is likely that there will be significant health deterioration within the two years of follow up.

* Significant peripheral vascular disease or other limb problems which themselves would be expected to interfere with longevity or outcomes of the limb over the follow up period.

* Contraindications to hyperbaric therapy including pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified