Skip to main content
OpenTrials
Completed

NCT Number: NCT00264511

Hyperbaric Oxygen in Lower Leg Trauma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tibial Fracture Crush Injuries Fractures, Bone Leg Injuries Soft Tissue Injuries Soft Tissue Injury Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Hobart Hospital, Hobart, Tasmania, Australia

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric oxygen treatment

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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. Radiological union

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

    electronic image copies of radiographs recorded by treating hospitals

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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.

  9. 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

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Monash University
  • National Health and Medical Research Council, Australia

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2014
Study completion
2016
First posted
Dec 13, 2005
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.