Hyperbaric Oxygen in Lower Leg Trauma

August 30, 2023 updated by: Bayside Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred
  • Austria
      • Graz, Austria
        • Universitätsklinikum Graz
  • Chile
      • Santiago, Chile
        • Hospital del Trabajador
  • Czechia
      • Ostrava, Czechia, 728 80
        • City Hospital of Ostrava
  • India
    • Sarita Vihar
      • New Delhi, Sarita Vihar, India, 110076
        • Indraprastha Apollo Hospital
  • Italy
      • Rome, Italy
        • Policlinico Umberto 1, University of Rome
  • Portugal
    • Matosinhos
      • Senhora da Hora, Matosinhos, Portugal, 4454-509
        • Hospital Pedro Hispano
  • Sweden
      • Stockholm, Sweden
        • Karolinska Hospital
  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No hyperbaric oxygenation
Patients randomised to this group will receive standard trauma care.
Experimental: 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.
Other: 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.
Other Names:
  • Hyperbaric oxygen therapy
  • Hyperbaric Oxygen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amputation rate
Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma
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
Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma
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
Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma
electronic image copies of radiographs recorded by treating hospitals
3, 6, 9, 12, 18 and 24 months post trauma
Quality of life score
Time Frame: 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)
3, 6, 9, 12, 18 and 24 months post trauma
Functional outcome score
Time Frame: 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)
3, 6, 9, 12, 18 and 24 months post trauma
Pain score
Time Frame: 3, 6, 9, 12, 18 and 24 months post trauma
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
Time Frame: 12 months post trauma
Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems
12 months post trauma
Wound persistence
Time Frame: 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.
3, 6, 9, 12, 18 and 24 months post trauma
Problem Wounds
Time Frame: 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
12 months post trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

National Health and Medical Research Council, Australia
Monash University

Investigators

  • Study Chair: Ian L Millar, MBBS, Bayside Health
  • Principal Investigator: Owen Williamson, Monash University
  • Principal Investigator: Peter Cameron, Monash University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 13, 2007

Primary Completion (Actual)

August 18, 2014

Study Completion (Actual)

March 23, 2016

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimated)

December 13, 2005

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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