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Tibial FracturePhase 2/3NCT00264511

Hyperbaric Oxygen in Lower Leg Trauma

A Phase 2/3 study testing Hyperbaric Oxygen Treatment in people with Tibial Fracture and Soft Tissue Injury, run by Bayside Health at 10 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tibial Fracture, Soft Tissue Injury
What is being tested?
Hyperbaric Oxygen Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
10 sitesin 9 countries
Study dates
13 Feb 2007to 23 Mar 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Significant head injury
  • Injuries incompatible with HBO
  • resuscitation requirements incompatible with HBO
  • follow up not possible
  • hyperbaric contra indications

Trial locations and contacts

10 sites in 9 countries.

10 sites in 9 countries

Australia2 sites

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • The Alfred

    Melbourne, Victoria, 3004

Other trials in Australia

United States1 site

  • John Muir Clinical Research Center

    Concord, California, 94520

Other trials in United States

Austria1 site

  • Universitatsklinikum Graz

    Graz

Other trials in Austria

Chile1 site

  • Hospital del Trabajador

    Santiago

Other trials in Chile

Czechia1 site

  • City Hospital of Ostrava

    Ostrava, 728 80

Other trials in Czechia

India1 site

  • Indraprastha Apollo Hospital

    New Delhi, Sarita Vihar, 110076

Other trials in India

Italy1 site

  • Policlinico Umberto 1, University of Rome

    Rome

Other trials in Italy

Portugal1 site

  • Hospital Pedro Hispano

    Senhora da Hora, Matosinhos, 4454-509

Other trials in Portugal

Sweden1 site

  • Karolinska Hospital

    Stockholm

Other trials in Sweden

About this study

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.

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.

Read the 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)

Being tested
Hyperbaric Oxygen Treatment
Keywords
Hyperbaric oxygen, Crush injury, Tibial fracture, Gustillo 3, soft tissue injury, complications, outcomes, randomised controlled trial
Medical subject headings
Tibial Fractures, Soft Tissue Injuries, Crush Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric Oxygen TreatmentOther

    Also called Hyperbaric oxygen therapy, Hyperbaric Oxygen

    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.

Study groups in NCT00264511
Study groupRoleWhat they receive
Hyperbaric oxygen treatmentExperimentalSubjects 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.
Receives: Other: Hyperbaric Oxygen Treatment
No hyperbaric oxygenationNo interventionPatients randomised to this group will receive standard trauma care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 14 days post trauma

Secondary outcomes (9)

  1. Amputation rate

    operative procedure records of a limb amputation related to the trauma under study

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  2. Late infection

    records of diagnosis of wound infection or osteomyelitis or implant infection at defined times

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  3. Radiological union

    electronic image copies of radiographs recorded by treating hospitals

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  4. 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)

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  5. Functional outcome score

    lower limb function component of Short Musculoskeletal Function Assessment ((each question is scored 1-5 with lower score better)

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  6. Pain score

    Subjects self reported pain using a 0-10 visual analogue scale

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  7. Delayed union of fracture

    Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems

    Measured: 12 months post trauma

  8. Wound persistence

    A record of whether any injury related wound remains open at review. Excludes new surgical wounds.

    Measured: 3, 6, 9, 12, 18 and 24 months post trauma

  9. 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

    Measured: 12 months post trauma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2005 (estimated)
  2. Study start13 Feb 2007
  3. Primary completion18 Aug 2014
  4. Study completion23 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00264511
Sponsor's protocol ID
206/04
Status last verified
Aug 2023
First submitted
12 Dec 2005
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Bouachour G, Cronier P, Gouello JP, Toulemonde JL, Talha A, Alquier P. Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial. J Trauma. 1996 Aug;41(2):333-9. doi: 10.1097/00005373-199608000-00023.

    PubMed 8760546

  • Garcia-Covarrubias L, McSwain NE Jr, Van Meter K, Bell RM. Adjuvant hyperbaric oxygen therapy in the management of crush injury and traumatic ischemia: an evidence-based approach. Am Surg. 2005 Feb;71(2):144-51.

    PubMed 16022014

  • Millar IL, McGinnes RA, Williamson O, Lind F, Jansson KA, Hajek M, Smart D, Fernandes T, Miller R, Myles P, Cameron P. Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial. BMJ Open. 2015 Jun 11;5(6):e008381. doi: 10.1136/bmjopen-2015-008381.

    PubMed 26068515

  • Millar IL, Lind FG, Jansson KA, Hajek M, Smart DR, Fernandes TD, McGinnes RA, Williamson OD, Miller RK, Martin CA, Gabbe BJ, Myles PS, Cameron PA; HOLLT investigator group. Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multi-centre randomised clinical trial. Diving Hyperb Med. 2022 Sep 30;52(3):164-174. doi: 10.28920/dhm52.3.164-174.

    PubMed 36100927

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hyperbaric Oxygen Treatment in people with Tibial Fracture and Soft Tissue Injury, run by Bayside Health at 10 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia, United States, Austria, Chile, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute phase complication rate (time frame: up to 14 days post trauma). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00264511, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.

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