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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hand burns

Condition category

Condition code

Injuries and Accidents

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]

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]

Oedema as measured by bioimpedance spectroscopy and volumetry

Timepoint [1]

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]

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]

Upon initial application of the compression
- Reassessment prior to the removal of the compression 24 hours later

Secondary outcome [2]

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]

At 24 hours post application of the dressings, prior to change of dressings

Secondary outcome [3]

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]

At initial intervention for oedema management

Secondary outcome [4]

Patient reported outcome
- The patient will complete the shortened version of the Disability of the Arm, Shoulder and Hand questionnaire (Quick-DASH)

Timepoint [4]

- Quick-DASH will be recorded at baseline, and at each change of compression (ie 24 hours after application)

Secondary outcome [5]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

18/10/2016

Actual

30/11/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Fiona Wood Foundation

Address [1]

Fiona Stanley Hospital
MNH (B) Main Hospital
CD15, Level 4, Burns Unit
102-118 Murdoch Drive
Murdoch WA 6150

Country [1]

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]

Hospital

Name [1]

Fiona Stanley Hospital

Address [1]

102-118 Murdoch Drive
Murdoch WA 6150

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Notre Dame Australia Human Research Ethics Committee

Ethics committee address [1]

32 Mouat St
Fremantle WA 6959

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/06/2016

Approval date [1]

22/08/2016

Ethics approval number [1]

016128F

Ethics committee name [2]

South Metropolitan Health Service (SMHS) Human Research Ethics Committee (HREC)

Ethics committee address [2]

Locked Bag 100
PALMYRA DC WA 6961
Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

28/06/2016

Approval date [2]

29/08/2016

Ethics approval number [2]

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

Mr Dale Edwick

Address

c/- State Adult Burns Unit
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Country

Australia

Phone

+61 409 297 622

Fax

[email protected]

Contact person for public queries

Name

Dale Edwick

Address

c/- State Adult Burns Unit
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Country

Australia

Phone

+61 409 297 622

Fax

[email protected]

Contact person for scientific queries

Name

Dale Edwick

Address

c/- State Adult Burns Unit
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Country

Australia

Phone

+61 409 297 622

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No ethics approval for sharing participant data

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Plain language summary	No	Bioimpedance spectroscopy was validated as a measu... [More Details]
Study results article	Yes	Edwick, D. O., Hince, D. A., Rawlins, J. M., Wood,... [More Details]
Study results article	Yes	Edwick, D. O., Hince, D. A., Rawlins, J. M., Wood,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomized controlled trial of compression interventions for managing hand burn edema, as measured by bioimpedance spectroscopy.	2020	https://dx.doi.org/10.1093/jbcr/iraa104

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically