Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000902190p
Ethics application status
Submitted, not yet approved
Date submitted
18/01/2019
Date registered
27/06/2019
Date last updated
27/06/2019
Date data sharing statement initially provided
27/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Hyperbaric oxygen therapy for lower limb burns in diabetic patients
Scientific title
Effect of hyperbaric oxygen on wound healing and scar outcome in diabetic patients with lower limb burns
Secondary ID [1] 297137 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 311169 0
Burn Injury 311170 0
Condition category
Condition code
Metabolic and Endocrine 309789 309789 0 0
Diabetes
Injuries and Accidents 311778 311778 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing and scar outcome.

Diabetic patients with lower limb burns who require debridement and skin grafting would be randomised to receive either:
HBOT post-operatively
OR sham HBOT
This treatment of sham treatment would be delivered at Fiona Stanley Hyperbaric medicine department by trained hyperbaric technicians.

These treatments would be delivered daily for 2-4 weeks.
After the treatment or sham treatment, the patient would receive standard care for all wounds.
Intervention code [1] 313403 0
Treatment: Other
Comparator / control treatment
Control group would receive exactly the same treatment apart from the dive in the hyperbaric chamber would be a sham dive, not delivering the hyperbaric oxygen

Treatment arm – 111minutes of 140kPa Oxygen filled chamber
Control arm – 111 minutes of 30kPa air filled chamber
Follow up = same for both arms
Control group
Placebo

Outcomes
Primary outcome [1] 318748 0
Percentage wound healing assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a 3D camera to map the area of the healed/unhealed area of wound to form a ratio.

Primary timepoint: 4 weeks (primary timepoint), 3months, 6 months and 12 months
Timepoint [1] 318748 0
4 weeks post surgery
Secondary outcome [1] 365914 0
Scar quality:
Vancouver Scar Scale
Timepoint [1] 365914 0
6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery
Secondary outcome [2] 371887 0
Scar quality:
Patient and Observer Assessment scar score
Timepoint [2] 371887 0
6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery
Secondary outcome [3] 371888 0
Scar quality:
Dermalab measurements (pigmentation, vascularity, scar thickness and elastography)
Timepoint [3] 371888 0
6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery
Secondary outcome [4] 371889 0
Quality of life:
SF36
Timepoint [4] 371889 0
3 months post-surgery
6 months post-surgery
1 year post-surgery
Secondary outcome [5] 371890 0
Quality of life: Brisbane Burn Scar Impact Profile
Timepoint [5] 371890 0
3 months post-surgery
6 months post-surgery
1 year post-surgery
Secondary outcome [6] 371891 0
Quality of life:
Structured interviews - 30 minutes by telephone, one-on-one, audio recorded and transcribed
Timepoint [6] 371891 0
3 months post-surgery
6 months post-surgery
1 year post-surgery

Eligibility
Key inclusion criteria
Adults 18+ years of age
Burn below knee on one or both legs
First presentation with burn on index limb
Type I or II diabetes mellitus
Able to consent to trial
Fluent in verbal and written English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or lactating women
Patients who fail the pre-hyperbaric treatment ear pressure test for barotrauma and would require tympanostomy tubes (grommets)
Patients who would not pass the screening process for standard hyperbaric treatment (those treated with Bleomycin (increases risk of pulmonary fibrosis); patients with current brain tumours or carbon monoxide poisoning (increased risk of oxygen toxicity) or with existing cataracts (can increase progression)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using factors of age, gender and ethnicity
Computerised sequence generation using random number generator assignation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study trial of 30 patients as not enough data known on healing percentage/times of diabetic burn lower limbs with and without hyperbaric oxygen to determine standard deviations
Non-parametric tests used for smaller number of group - Kruksall-Wallis tests

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
1/09/2020
Actual
Date of last data collection
Anticipated
6/09/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12963 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 25441 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 301697 0
Charities/Societies/Foundations
Name [1] 301697 0
Fiona Wood Foundation
Country [1] 301697 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6158 WA
Country
Australia
Secondary sponsor category [1] 301422 0
None
Name [1] 301422 0
None
Address [1] 301422 0
None
Country [1] 301422 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302416 0
Department of Health WA Human research ethics committee
Ethics committee address [1] 302416 0
PO Box 8172
Perth Business Centre
Perth WA 6849
Ethics committee country [1] 302416 0
Australia
Date submitted for ethics approval [1] 302416 0
25/06/2019
Approval date [1] 302416 0
Ethics approval number [1] 302416 0

Summary
Brief summary
This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing.
Diabetic lower limb burns are very common - a recent audit performed in our service revealed 35 such injuries over the past 18 months, 75% of which required debridement and skin grafting. It also identified that these patient stay on average 2.5 times longer in hospital than our normal average length of stay. In addition a third require a second operation and due to poor healing 23% proceeded to some form of amputation.
Hyperbaric oxygen therapy has been used increasingly to assist with healing of complex and chronic wounds, however robust evidence for its use, particularly in burns, is still lacking. At Fiona Stanley Hospital we have a HBOT unit and are the adult tertiary referral service for burn injuries. We therefore propose to perform a double blind randomised controlled trial looking at diabetic lower limb burns which required debridement and skin grafting. All diabetic patients with deep lower limb burns would be considered for the trial and would have debridement, skin grafting and VAC therapy within 72 hours of presentation to our service. Immediately post-operatively they would be randomised to receive either HBOT post-operatively OR sham HBOT. These treatments would be delivered daily for 2-4 weeks. After the treatment or sham treatment, the patient would receive standard care for all wounds.
At 4 weeks the wounds would be assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a camera to map the area of the healed/unhealed area of wound to form a ratio.
At 3, 6 and 12 months the wounds would be assessed for healing, time in dressings, episodes of breakdown, requirements for secondary surgery and QoL
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90170 0
Dr Helen Douglas
Address 90170 0
State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA
Country 90170 0
Australia
Phone 90170 0
+61 861522222
Fax 90170 0
Email 90170 0
helen.douglas@health.wa.gov.au
Contact person for public queries
Name 90171 0
Dr Helen Douglas
Address 90171 0
State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA
Country 90171 0
Australia
Phone 90171 0
+61 861522222
Fax 90171 0
Email 90171 0
helen.douglas@health.wa.gov.au
Contact person for scientific queries
Name 90172 0
Dr Helen Douglas
Address 90172 0
State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA
Country 90172 0
Australia
Phone 90172 0
+61 861522222
Fax 90172 0
Email 90172 0
helen.douglas@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data would be considered for sharing on request, but not automatically
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Other researchers in the field with methodologically sound proposals whose research may benefit from our de-identified data - at the discretion of study investigators and sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator to be emailed at FSH.BurnResearch@health.wa.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.