Tibial Fracture, Soft Tissue Injury
Conditions
Keywords
Hyperbaric oxygen, Crush injury, Tibial fracture, Gustillo 3, soft tissue injury, complications, outcomes, randomised controlled trial
Brief 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.
Detailed description
A randomised controlled trial was undertaken on using hyperbaric oxygen in addition to standard orthopaedic trauma care in severe lower leg injury, defined as an open tibial fracture with severe soft tissue injury. The control arm subjects received standard hospital trauma care whilst the intervention group received standard trauma care with the addition of hyperbaric oxygen therapy with the aim of providing 12 HBOT sessions over the first 9 days of hospital care. The primary outcome measure was the incidence of wound necrosis AND/OR wound infection as assessed at Day 14, with secondary outcomes of wound closure, wound complications, infections and delayed bone union at 12 months plus quality of life and functional questionnaire outcomes at 12 months and 2 years. The detailed study protocol was published in in June 2015 and the results were published in September 2022. Both publications are Open Access (See References section for publication details)
Interventions
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
Monash University
National Health and Medical Research Council, Australia
Bayside Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Surgeons initially operating were unaware of allocation. Outcomes arbitrations were conducted by surgeons blind to intervention allocation. Chief investigator masked until follow up data finally received and records locked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute phase complication rate | up to 14 days post trauma | The incidence of acute complications after injury. A composite measure defined as the occurrence within two weeks of trauma of one or both of: significant soft tissue necrosis developing after the initial surgery or significant wound infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late infection | 3, 6, 9, 12, 18 and 24 months post trauma | records of diagnosis of wound infection or osteomyelitis or implant infection at defined times |
| Radiological union | 3, 6, 9, 12, 18 and 24 months post trauma | electronic image copies of radiographs recorded by treating hospitals |
| Quality of life score | 3, 6, 9, 12, 18 and 24 months post trauma | Short Form 36 quality of life questionnaire (algorithm produces a score in the range of 0-100 with higher score better) |
| Functional outcome score | 3, 6, 9, 12, 18 and 24 months post trauma | lower limb function component of Short Musculoskeletal Function Assessment ((each question is scored 1-5 with lower score better) |
| Amputation rate | 3, 6, 9, 12, 18 and 24 months post trauma | operative procedure records of a limb amputation related to the trauma under study |
| Delayed union of fracture | 12 months post trauma | Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems |
| Wound persistence | 3, 6, 9, 12, 18 and 24 months post trauma | A record of whether any injury related wound remains open at review. Excludes new surgical wounds. |
| Problem Wounds | 12 months post trauma | Blinded evaluation of whether post traumatic wounds met the criteria for Problem Wounds as a result of requiring readmission to hospital, prolonged wound care, additional surgery or antibiotics that complicated or deteriorated patient recovery |
| Pain score | 3, 6, 9, 12, 18 and 24 months post trauma | Subjects self reported pain using a 0-10 visual analogue scale |
Countries
Australia, Austria, Chile, Czechia, India, Italy, Portugal, Sweden, United States
Outcome results
None listed