Hyperbaric Oxygen in Lower Leg Trauma

Study Overview
=================
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)

Official Title
-----------------
Does Hyperbaric Oxygen Reduce Complications and Improve Outcomes After Open Tibial Fractures With Severe Soft Tissue Injury? An International Multi-centre Randomized Controlled Trial.

Conditions
-----------------
Tibial Fracture, Soft Tissue Injury

Intervention / Treatment
-----------------
* Other: Hyperbaric Oxygen Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen treatment<br>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. | Other: Hyperbaric Oxygen Treatment<br>* 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.<br>* Other names: Hyperbaric Oxygen;|
| No Intervention: No hyperbaric oxygenation<br>Patients randomised to this group will receive standard trauma care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute phase complication rate | 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. | up to 14 days post trauma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation rate | operative procedure records of a limb amputation related to the trauma under study | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Late infection | records of diagnosis of wound infection or osteomyelitis or implant infection at defined times | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Radiological union | electronic image copies of radiographs recorded by treating hospitals | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Quality of life score | Short Form 36 quality of life questionnaire (algorithm produces a score in the range of 0-100 with higher score better) | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Functional outcome score | lower limb function component of Short Musculoskeletal Function Assessment ((each question is scored 1-5 with lower score better) | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Pain score | Subjects self reported pain using a 0-10 visual analogue scale | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Delayed union of fracture | Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems | 12 months post trauma | 
| Wound persistence | A record of whether any injury related wound remains open at review. Excludes new surgical wounds. | 3, 6, 9, 12, 18 and 24 months post trauma | 
| Problem Wounds | 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 | 12 months post trauma | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperbaric oxygen, Crush injury, Tibial fracture, Gustillo 3, soft tissue injury, complications, outcomes, randomised controlled trial