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CompletedPhase 2Phase 3ACTRN12607000559415

Hyperbaric Oxygen in Lower Limb Trauma

In open tibial fractures with severe soft tissue injury, does an early course of hyperbaric oxygen, when compared with standard trauma care, reduce acute soft tissue complication rates and improve short and long term outcomes?

Sponsor

Alfred Health

Enrollment

120 participants

Start Date

Feb 13, 2007

Study Type

Interventional

Conditions

Acute open fractures of the tibia with associated severe soft tissue injuryOutcomesTraumaFractureComplications of Injury

Summary

Hyperbaric oxygen therapy may reduce injury related complications and improve outcomes following serious musculo-skeletal injury. The Hyperbaric Oxygen in Lower Limb Trauma (HOLLT) Study will investigate this by conducting a randomised controlled trial aiming to enrol 120 patients with severe tibial fractures within 48 hours of their injury. The study is being conducted by an international network of trauma centres with hyperbaric treatment facilities.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about hyperbaric Oxygen in Lower Limb Trauma. It is looking for adults aged 18 and older to participate. To join, participants should meet requirements such as: 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. Participants will be guided through the study procedures by the research team and may need to attend scheduled visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A course of 12 hyperbaric oxygen (HBO) therapy sessions over approximately 8 days, commencing within 48 hours of injury. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for a

A course of 12 hyperbaric oxygen (HBO) therapy sessions over approximately 8 days, commencing within 48 hours of injury. 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. Patient follow up will continue for 2 years.

Locations(11)

Rome, Italy

Pilsen, Czech Republic

Stockholm, Sweden

Oslo, Norway

Cape Town, South Africa

Ostrava, Czech Republic

Graz, Austria

Matosinhos, Portugal

New Delhi, India

Walnut Creek, California, United States of America

Santiago, Chile

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ACTRN12607000559415

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