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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
206/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial Fracture 0 0
Soft Tissue Injury 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute phase complication rate
Timepoint [1] 0 0
up to 14 days post trauma
Secondary outcome [1] 0 0
Amputation rate
Timepoint [1] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [2] 0 0
Late infection
Timepoint [2] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [3] 0 0
Radiological union
Timepoint [3] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [4] 0 0
Quality of life score
Timepoint [4] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [5] 0 0
Functional outcome score
Timepoint [5] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [6] 0 0
Pain score
Timepoint [6] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [7] 0 0
Delayed union of fracture
Timepoint [7] 0 0
12 months post trauma
Secondary outcome [8] 0 0
Wound persistence
Timepoint [8] 0 0
3, 6, 9, 12, 18 and 24 months post trauma
Secondary outcome [9] 0 0
Problem Wounds
Timepoint [9] 0 0
12 months post trauma

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant head injury
* Injuries incompatible with HBO
* resuscitation requirements incompatible with HBO
* follow up not possible
* hyperbaric contra indications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2016
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Chile
State/province [3] 0 0
Santiago
Country [4] 0 0
Czechia
State/province [4] 0 0
Ostrava
Country [5] 0 0
India
State/province [5] 0 0
Sarita Vihar
Country [6] 0 0
Italy
State/province [6] 0 0
Rome
Country [7] 0 0
Portugal
State/province [7] 0 0
Matosinhos
Country [8] 0 0
Sweden
State/province [8] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00264511
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.
Public notes

Contacts
Principal investigator
Name 0 0
Ian L Millar, MBBS
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00264511