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Trial registered on ANZCTR


Registration number
ACTRN12620000715976
Ethics application status
Approved
Date submitted
20/04/2020
Date registered
2/07/2020
Date last updated
2/07/2020
Date data sharing statement initially provided
2/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Early versus Late Endermologie® Vacuum Therapy Evaluation (ELEVaTE)
Scientific title
Feasibility, Acceptability and Safety of Vacuum Therapy on Burn Scar outcomes
Secondary ID [1] 300517 0
Nil Known
Universal Trial Number (UTN)
U1111-1248-0878
Trial acronym
ELEVaTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn Scars 316209 0
Severe Burn Injuries 316210 0
Skin Grafting 316211 0
Burns 317857 0
Condition category
Condition code
Injuries and Accidents 314500 314500 0 0
Burns
Surgery 314501 314501 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Early Vacuum Therapy
Participants in the early group will the receive once a week vacuum therapy over an 8-week period commencing at 8 - 12 weeks post skin grafting. Vacuum Therapy treatment head, settings and duration of treatments will be decided by the treating Occupational Therapist after clinical assessment and recorded.

Group 2: Late Vacuum Therapy
Patients in the late group will receive once a week vacuum therapy over an 8-week period at 6 months post skin grafting. Vacuum Therapy treatment head, settings and duration of treatments will be decided by the treating Occupational Therapist after clinical assessment and recorded.

Derma Lab Ultrasound (Cortex Technology, Denmark)
Ultrasound will be used to assess scar thickness. The Derma Lab Ultrasound is a high frequency, high resolution ultrasound scanner which objectively captures and reproduces skin thickness.

Intervention code [1] 316824 0
Treatment: Devices
Intervention code [2] 317817 0
Rehabilitation
Comparator / control treatment
To compare early intervention (-8 – 12 weeks) with later intervention (6 months) using key scar and functional end points measured at 12 months post injury
Control group
Active

Outcomes
Primary outcome [1] 323532 0
Brisbane Burn Scar Impact Profile (BBSIP)
Timepoint [1] 323532 0
Baseline, 6 and 12-months post commencement of vacuum therapy
Primary outcome [2] 323785 0
Patient Observer Scar Assessment Scale (POSAS)
Timepoint [2] 323785 0
Baseline, 6 and 12-months post commencement of vacuum therapy
Primary outcome [3] 323786 0
EQ-5D-5L (Quality of life),
Timepoint [3] 323786 0
Baseline, 6 and 12-months post commencement of vacuum therapy
Secondary outcome [1] 382180 0
Scar height will be objectively assessed using the DermaLab ® series ultrasound (CORTEX Technology).
Timepoint [1] 382180 0
Baseline, 6 and 12-months post commencement of vacuum therapy
Secondary outcome [2] 382893 0
Short Assessment of Patient Satisfaction (SAPS)
Timepoint [2] 382893 0
Baseline, 6 and 12-months post commencement of vacuum therapy
Secondary outcome [3] 383785 0
Number of adverse effects will be recorded.
These effects might include skin reactions, breakdown or discomfort. Should an adverse event occur, treatment will be ceased and the participant provided with appropriate alternative care.
All observed or volunteered adverse effects and, if applicable, or suspected causal relationship to the investigational device will be recorded in the subjects’ case notes.
Data will be collected from the case notes and documented onto paper case report forms (CRFs)
Timepoint [3] 383785 0
6 and 12-months
Secondary outcome [4] 383786 0
Resource usage:
Time by clinician
Number of sessions
Data will be collected at study time points and documented onto paper case report forms (CRFs) in a timely manner for each outcome named above.
The time for clinician intervention will be recorded using a stop watch and transcribed into the CRFs.
The number of sessions will be collected from the electronic booking systems and transcribed in the CRFs.
Timepoint [4] 383786 0
Baseline, 6 and 12-months

Eligibility
Key inclusion criteria
Total Body Surface Area (TBSA) burn <15%
Scar present on a limb will be eligible for Vacuum
Scar to be treated is a grafted region which can be no larger than 10% TBSA
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients aged <18 years without parental consent
TBSA >50%
Pregnancy
Inability/unwilling to return for follow up
Inability to provide informed consent
Non-English speaking
Patients with underlying medical or surgical history that is a contraindication to vacuum therapy.
Scars to the face, neck or genitals will not be included

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)
Envelopes containing the concealed allocations will be held by a team member not involved in the trial. Once a patient consent, an ELEVaTE team member will request and allocation envelope to determine randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics such as the means and standard deviations for continuous outcomes and the median and mode for non-continuous outcomes will be used to report the sample demographics and clinical characteristics and to summarize the outcomes, as appropriate.

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment postcode(s) [1] 30052 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 304930 0
Hospital
Name [1] 304930 0
Jamieson Trauma Institute, Royal Brisbane and Women's Hospital
Address [1] 304930 0
Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country [1] 304930 0
Australia
Primary sponsor type
Hospital
Name
Jamieson Trauma Institute, Royal Brisbane and Women's Hospital
Address
Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 305914 0
None
Name [1] 305914 0
Address [1] 305914 0
Country [1] 305914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305337 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 305337 0
Level 13, Block 7, Royal Brisbane and Women’s Hospital HERSTON QLD 4029
Ethics committee country [1] 305337 0
Australia
Date submitted for ethics approval [1] 305337 0
28/01/2020
Approval date [1] 305337 0
10/02/2020
Ethics approval number [1] 305337 0
HREC/2020/QRBW/61409

Summary
Brief summary
Hypothesis
That the feasibility, acceptability, cost and effectiveness of early intervention using Vacuum Therapy in the management of burns scars will be supported, in addition to an improvement in scar parameter outcomes in the early intervention cohort when compared to the later intervention cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100050 0
Miss Andrea Mc Kittrick
Address 100050 0
Department of Occupational Therapy
Royal Brisbane and Women's Hospital
Level2 Dr James Mayne Building
Butterfield Street
Herston
QLD 4029
Country 100050 0
Australia
Phone 100050 0
+61 7 3646 7100
Fax 100050 0
Email 100050 0
Andrea.McKittrick@health.qld.gov.au
Contact person for public queries
Name 100051 0
Miss Andrea Mc Kittrick
Address 100051 0
Department of Occupational Therapy
Royal Brisbane and Women's Hospital
Level2 Dr James Mayne Building
Butterfield Street
Herston
QLD 4029
Country 100051 0
Australia
Phone 100051 0
+61 7 3646 7100
Fax 100051 0
Email 100051 0
Andrea.McKittrick@health.qld.gov.au
Contact person for scientific queries
Name 100052 0
Miss Andrea Mc Kittrick
Address 100052 0
Department of Occupational Therapy
Royal Brisbane and Women's Hospital
Level2 Dr James Mayne Building
Butterfield Street
Herston
QLD 4029
Country 100052 0
Australia
Phone 100052 0
+61 7 3646 7100
Fax 100052 0
Email 100052 0
Andrea.McKittrick@health.qld.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
Results of this will be reported back to the Jamieson Trauma Institute Research Advisory Council. Results will also be presented at the Herston symposium and other relevant conferences. Articles will be presented to journals for possible publication once prepared.
What supporting documents are/will be available?
No other documents available
Summary results
No Results