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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00264511
Registration number
NCT00264511
Ethics application status
Date submitted
12/12/2005
Date registered
13/12/2005
Date last updated
5/09/2023
Titles & IDs
Public title
Hyperbaric Oxygen in Lower Leg Trauma
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Scientific 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.
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Secondary ID [1]
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206/04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tibial Fracture
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Soft Tissue Injury
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Condition category
Condition code
Skin
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Other skin conditions
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Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Hyperbaric Oxygen Treatment
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.
No Intervention: No hyperbaric oxygenation - Patients randomised to this group will receive standard trauma care.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Acute phase complication rate
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Assessment method [1]
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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.
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Timepoint [1]
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up to 14 days post trauma
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Secondary outcome [1]
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Amputation rate
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Assessment method [1]
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operative procedure records of a limb amputation related to the trauma under study
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Timepoint [1]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [2]
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Late infection
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Assessment method [2]
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records of diagnosis of wound infection or osteomyelitis or implant infection at defined times
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Timepoint [2]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [3]
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Radiological union
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Assessment method [3]
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electronic image copies of radiographs recorded by treating hospitals
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Timepoint [3]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [4]
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Quality of life score
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Assessment method [4]
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Short Form 36 quality of life questionnaire (algorithm produces a score in the range of 0-100 with higher score better)
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Timepoint [4]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [5]
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Functional outcome score
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Assessment method [5]
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lower limb function component of Short Musculoskeletal Function Assessment ((each question is scored 1-5 with lower score better)
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Timepoint [5]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [6]
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Pain score
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Assessment method [6]
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Subjects self reported pain using a 0-10 visual analogue scale
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Timepoint [6]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [7]
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Delayed union of fracture
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Assessment method [7]
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Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems
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Timepoint [7]
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12 months post trauma
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Secondary outcome [8]
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Wound persistence
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Assessment method [8]
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A record of whether any injury related wound remains open at review. Excludes new surgical wounds.
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Timepoint [8]
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3, 6, 9, 12, 18 and 24 months post trauma
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Secondary outcome [9]
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Problem Wounds
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Assessment method [9]
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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
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Timepoint [9]
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12 months post trauma
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Significant head injury
- Injuries incompatible with HBO
- resuscitation requirements incompatible with HBO
- follow up not possible
- hyperbaric contra indications
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/03/2016
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
TAS,VIC
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Recruitment hospital [1]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [2]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
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7000 - Hobart
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Austria
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State/province [2]
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Graz
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Country [3]
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Chile
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State/province [3]
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Santiago
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Country [4]
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Czechia
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State/province [4]
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Ostrava
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Country [5]
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India
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State/province [5]
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Sarita Vihar
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Country [6]
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Italy
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State/province [6]
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Rome
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Country [7]
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Portugal
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State/province [7]
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Matosinhos
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Country [8]
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Sweden
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State/province [8]
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Stockholm
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Health and Medical Research Council, Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00264511
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Trial related presentations / 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.
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.
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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Ian L Millar, MBBS
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Address
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Bayside Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00264511
Download to PDF