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?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000559415

Acronym

HOLLT

Enrollment

120

Registered

2007-10-31

Start date

2007-02-13

Completion date

2014-08-18

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Patient follow up will continue for 2 years.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

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

Outcome results