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Trial registered on ANZCTR


Registration number
ACTRN12616000810415
Ethics application status
Approved
Date submitted
14/06/2016
Date registered
21/06/2016
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement and management of swelling after hand burn injury
Scientific title
Efficacy of different cohesive bandage application methods for the management of oedema after hand burn injury, as measured by bioimpedance spectroscopy (BIS) and water displacement volumetry.
Secondary ID [1] 289440 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand burns 299133 0
Condition category
Condition code
Injuries and Accidents 299151 299151 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compression through the use of different methods of application of cohesive bandage - 3M Coban - for the management of hand oedema
Group One - spiral Coban application to the fingers and to the hand
Group Two - spiral Coban application to the fingers and figure-of-eight application to the hand
Group Three - cylindrical pinch application to the fingers and spiral application to the hand
Group Four - cylindrical pinch application to the fingers and figure-of-eight application to the hand
Each application method will be applied for a 24 hour period prior to reassessment and change of dressings, and that method will be reapplied at the change of dressing. The compressive bandaging will be applied by the ward physiotherapists as per the allocated method. The compression bandaging will be assessed prior to the next removal of dressings to monitor adherence.
Intervention code [1] 295031 0
Treatment: Devices
Comparator / control treatment
Active control - Norco Therapeutic compression glove
- Full finger glove that extends over the wrist.
- Made of Lycra and nylon
Participants allocated to the active control group will be required to wear a compression glove over the burns dressings. Participants will wear the glove for a 24 hour duration prior to re-assessment of oedema at the change of dressings, and then reapplied. The glove will be applied by the ward physiotherapists according to the participant allocation.
Control group
Active

Outcomes
Primary outcome [1] 298628 0
Oedema as measured by bioimpedance spectroscopy and volumetry
Timepoint [1] 298628 0
Initial measurement will be collected on enrolment into the study.
- Subsequent measurement will be after 24 hours of the compression intervention for the management of the oedema
Secondary outcome [1] 324803 0
Hand range of movement with compression in situ
- Composite finger flexion as measured by the distance from the little fingernail/finger tip junction to the distal palmar crease on making a fist
- Thumb opposition - as measured by the Kapandji scale
Timepoint [1] 324803 0
Upon initial application of the compression
- Reassessment prior to the removal of the compression 24 hours later
Secondary outcome [2] 324804 0
Integrity of compression
- Burn wound exudate leakage from dressings may result in a loss of integrity of the cohesive bandage applied to manage oedema
- Photographic recording of compressive dressings to record wound leakage into dressings
- Recording of number of separations of the compressive bandaging
Timepoint [2] 324804 0
At 24 hours post application of the dressings, prior to change of dressings
Secondary outcome [3] 324805 0
Cost of intervention
- The time taken to apply each method of compression will be recorded, and calculated against the salary of the physiotherapist applying the compression as a measure of cost of time
- The cost of the materials used to apply the compression will be recorded
Timepoint [3] 324805 0
At initial intervention for oedema management
Secondary outcome [4] 324806 0
Patient reported outcome
- The patient will complete the shortened version of the Disability of the Arm, Shoulder and Hand questionnaire (Quick-DASH)
Timepoint [4] 324806 0
- Quick-DASH will be recorded at baseline, and at each change of compression (ie 24 hours after application)
Secondary outcome [5] 324842 0
Pressure exerted by compression, as measured by pressure sensors placed beneath the cohesive bandage.
Pressure will be assessed at rest, with active hand range of movement, and with passive range of movement
Timepoint [5] 324842 0
Pressure assessment upon initial application of compression, and prior to removal of compression at 24 hours post initial application

Eligibility
Key inclusion criteria
Burns including a portion of the hand
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Electrical burn injury
Circumferential hand burn injury
Pregnancy or breast feeding women
Implantable devices including pacemakers, cardiac defibrillators, stimulators
Renal disease or recent use of diuretic medication (within last 4 weeks)

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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5978 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 13400 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 293813 0
Charities/Societies/Foundations
Name [1] 293813 0
Fiona Wood Foundation
Address [1] 293813 0
Fiona Stanley Hospital
MNH (B) Main Hospital
CD15, Level 4, Burns Unit
102-118 Murdoch Drive
Murdoch WA 6150
Country [1] 293813 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
32 Mouat Street
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 292643 0
Hospital
Name [1] 292643 0
Fiona Stanley Hospital
Address [1] 292643 0
102-118 Murdoch Drive
Murdoch WA 6150
Country [1] 292643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295245 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 295245 0
32 Mouat St
Fremantle WA 6959
Ethics committee country [1] 295245 0
Australia
Date submitted for ethics approval [1] 295245 0
14/06/2016
Approval date [1] 295245 0
22/08/2016
Ethics approval number [1] 295245 0
016128F
Ethics committee name [2] 295246 0
South Metropolitan Health Service (SMHS) Human Research Ethics Committee (HREC)
Ethics committee address [2] 295246 0
Locked Bag 100
PALMYRA DC WA 6961
Australia
Ethics committee country [2] 295246 0
Australia
Date submitted for ethics approval [2] 295246 0
28/06/2016
Approval date [2] 295246 0
29/08/2016
Ethics approval number [2] 295246 0
2016-143

Summary
Brief summary
Parallel randomised controlled trial of different methods of application of cohesive bandage for the management of hand burn oedema, against a control method of an off the shelf compression glove.
Primary outcome measures will be change in oedema as measured by Bioimpedance Spectroscopy and volumetry, which will also be a validation of BIS for the measure of hand oedema in a burns population,
Secondary outcomes include hand range of movement, integrity of compression, pressure exerted by compression application technique, and patient self-reported hand function.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66682 0
Mr Dale Edwick
Address 66682 0
c/- State Adult Burns Unit
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country 66682 0
Australia
Phone 66682 0
+61 409 297 622
Fax 66682 0
Email 66682 0
dale.edwick@health.wa.gov.au
Contact person for public queries
Name 66683 0
Mr Dale Edwick
Address 66683 0
c/- State Adult Burns Unit
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country 66683 0
Australia
Phone 66683 0
+61 409 297 622
Fax 66683 0
Email 66683 0
dale.edwick@health.wa.gov.au
Contact person for scientific queries
Name 66684 0
Mr Dale Edwick
Address 66684 0
c/- State Adult Burns Unit
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country 66684 0
Australia
Phone 66684 0
+61 409 297 622
Fax 66684 0
Email 66684 0
dale.edwick@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics approval for sharing participant data
What supporting documents are/will be available?
No other documents available
Summary results
No Results