Hyperbaric Oxygen in Lower Leg Trauma
- Conditions
- Soft Tissue InjuryTibial Fracture
- Interventions
- Other: Hyperbaric Oxygen Treatment
- Registration Number
- NCT00264511
- Lead Sponsor
- Bayside Health
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- Significant head injury
- Injuries incompatible with HBO
- resuscitation requirements incompatible with HBO
- follow up not possible
- hyperbaric contra indications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyperbaric oxygen treatment Hyperbaric Oxygen Treatment 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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
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)
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.
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
Radiological union 3, 6, 9, 12, 18 and 24 months post trauma electronic image copies of radiographs recorded by treating hospitals
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
Trial Locations
- Locations (10)
Universitatsklinikum Graz
🇦🇹Graz, Austria
Karolinska Hospital
🇸🇪Stockholm, Sweden
Policlinico Umberto 1, University of Rome
🇮🇹Rome, Italy
City Hospital of Ostrava
🇨🇿Ostrava, Czechia
Hospital del Trabajador
🇨🇱Santiago, Chile
Hospital Pedro Hispano
🇵🇹Senhora da Hora, Matosinhos, Portugal
John Muir Clinical Research Center
🇺🇸Concord, California, United States
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Indraprastha Apollo Hospital
🇮🇳New Delhi, Sarita Vihar, India
The Alfred
🇦🇺Melbourne, Victoria, Australia