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Trial registered on ANZCTR


Registration number
ACTRN12618000245291
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
15/02/2018
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Autologous skin cell suspension in partial thickness paediatric burns: The BRACS Randomised Trial.
Scientific title
“The Biobrane®, RECELL® Autologous Cell Suspension and Silver Dressings Trial (BRACS Trial): A three arm prospective randomised controlled trial comparing a biological dressing (Biobrane®) with Biobrane® and RECELL® and with standard silver dressings in children with a significant superficial partial to mid dermal thickness burn.”
Secondary ID [1] 293743 0
nil known
Universal Trial Number (UTN)
nil known
Trial acronym
BRACS Trial: Biobrane®, RECELL® Autologous Cell Suspension and Silver Dressings Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Burns 306119 0
Condition category
Condition code
Injuries and Accidents 305239 305239 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be taken to the operation theatre for a general anaesthetic. There initially they will undergo a non-excisional debridement and cleaning with QV Wash within the first 48 hours after the burn injury has occurred.
ARM 1: one of the two standard initial dressings Acticoat® (Smith and Nephew, Hull, UK) with Mepitel® (Molnlycke, Goteborg, Sweden) or Mepilex Ag® (Molnlycke, Goteborg, Sweden) will be applied. The second dressing change will occur 3-5 days after this. Each dressing change will be as per the standard procedure with research assessments at each dressing change until the wound is 95% or more re-epithelialised or referred for a graft.
ARM 2: Once the wound bed is sufficiently prepared the surgeon will apply the autologous cell suspension using the RECELL® Autologous Cell Harvesting Device (AVITA Medical, California, USA) as per manufacturer’s recommendations. A layer of Biobrane® (Smith & Nephew Medical Ltd, Hull, UK) will be laid over the top of the RECELL® and edges will be secured with Hypafix® (BSN Medical GmBH, Hamburg, Germany). Over the top of the Biobrane® will be a layer of Jelonet® (Smith & Nephew Medical Ltd, Hull, UK) then Kerlix® (Covidien, Mansfield, Ma, USA), crepe bandage and secured by Hypafix®. The Jelonet®, Kerlix®, Crepe and external Hypafix® will be changed every 3-5 days until the wound is 95% or more re-epithelialised or Biobrane® is completely lifted.
DONOR SITE: Donor site location will be selected in a proximity as close as possible to the burn wound. The preparation of the site will undergo antimicrobial washing and irrigation. Once sufficient preparation has been achieved a pneumatic dermatome (Zimmer Inc., Warsaw, IN, USA) will be used to harvest a skin donor at a thickness of 6/1000 of an inch. Any excess autologous skin cell suspension will be applied to the donor site and dressed with Sorbact® (Abigo Medical AB, Gothenburg, Sweden)
ARM 3: Once the wound bed is sufficiently prepared the surgeon will apply a layer of Biobrane® over the burn and secured with Hypafix®. Over the top of the Biobrane® will be a layer of Jelonet® then Kerlix®, Crepe bandage and secured by Hypafix®. The Jelonet®, Kerlix®, crepe and external Hypafix® will be changed every 3-5 days until the wound is 95% or more re-epithelialised or Biobrane® is completely lifted.
Most of dressing changes will be completed by our burns nursing staff and where required a surgeon will also assist with the dressing changes.
Intervention code [1] 299997 0
Treatment: Devices
Comparator / control treatment
This study will implement active group controls( Arm 1: Standard Silver Dressings) as it would be unethical to implement an inferior dressing as a control.
Control group
Active

Outcomes
Primary outcome [1] 304394 0
Days to Re-epithelialisation
Days to Re-epithelialisation of burn will be assessed with the implentation of three methods:
1. Clinical judgement from the consultant;
2. 3D camera photographs and analysis on specialist computer software; and
3. Blinded review of the 3D photographs by a panel of burn specialists (consultants and nurses). The 3D images will be obtained using a static 3D LifeVizII System® (Quantificare S.A., Cedex, France) and analysed with the Dermapix® (Quantificare S.A., Cedex, France) software. A dynamic 3D image will be taken with the GPC 3D Woundcare ( GPC, Swansea, UK) system. The clinical judgement of the attending burns surgeon will be the main assessment modality.

Timepoint [1] 304394 0
Every 3-5 days (each dressing change) after intervention commencement until wound is > 95% re-epithelialized.
Secondary outcome [1] 341809 0
Pain To be assessed using Faces Pain Scale-Revised ( by participants older than 5 years); Numeric Rating Scale-Pain by all parents ( NRS-P Proxy ) and participants older than 8 years(NRS-P) and the Faces, Legs, Activity Cry, Consolability( FLACC) Scale, Pulse Rate and lastly Respiratory rate ( by nursing staff).
Timepoint [1] 341809 0
Every 3-5 days (each dressing change) after intervention commencement until wound is > 95% re-epithelialised
Secondary outcome [2] 341814 0
Ease of Dressing Application.
Burns consultants, nurses and occupational therapists will be surveyed for their opinions, using a survey created for this study, regarding the of the three dressings.
Timepoint [2] 341814 0
After each dressing change until the wound is > 95% re-epithelialized.
Secondary outcome [3] 341820 0
Burn Depth
Burn Depth will be assessed using a Moor LDLS-BI Laser Doppler Imager® (Moor
Instruments Ltd, Axminster, Devon, UK) by measuring blood perfusion at the burn site.
Timepoint [3] 341820 0
At first dressing application and subsequent 3-5 day dressing change until wound is > 95%re-epithelialisation
Secondary outcome [4] 341822 0
Itch intensity.
Acute itch intensity will be self-reported for children aged 8 years and older using an 11-point Numeric Rating Scale (NRS- I) and by parents ( NRS- I Proxy)of all children until the wound is > 95% re-epithelialised. Chronic itch intensity will be measured using the itch section of the POSAS and BBSIP instruments.
Timepoint [4] 341822 0
Acute Itch: at all change of dressing until the wound is > 95% Re-epithelialized

Chronic Itch: at the 3, 6, and 12 months post date of burn injury follow up visit.
Secondary outcome [5] 341823 0
Adverse Events/ Discontinuation.
The proposed interventions are considered to be part of the standard care at the participating burns centre, thus, minimal adverse events are expected.
Known potential adverse events (e.g. infection, haematoma or excessive exudates) have a standardised management protocol at the participating health service.
Monitoring of adverse effects of the dressings will be by reviewing patient medical records and by the self-report of caregivers, child participants (where appropriate) and treating therapists.
All adverse effects will be reported to the clinical health service and the overseeing Human Research Ethics Committee (HREC).
Discontinuation or alteration of treatment will be at the discretion of the treating clinical team and will be monitored throughout the study.
At the conclusion of the study participants will receive standard care.
Timepoint [5] 341823 0
Through the study at any specific time.
Last possible assessment will be at 12 months post date of burn injury.
Secondary outcome [6] 342974 0
Scar Assessment: Scar thickness Scar thickness will be measured using the Logiq e® (GE Healthcare, Fairfield, CT, USA). ultrasound machine. An average of three measurements will be recorded and used in the analysis.
Timepoint [6] 342974 0
This measurements will be taken at 3 ,6 and 12 months post date of burn injury.
Secondary outcome [7] 342976 0
Scar Assessment: Subjective Severity Subjective scar severity will be evaluated using the Patient and Observer Scar Assessment Scale(POSAS) by caregivers of all participants and participants will self-report if aged 8 years and over.
Timepoint [7] 342976 0
This measurements will be taken at 3 ,6 and 12 months post date of burn injury.
Secondary outcome [8] 342977 0
Scar Assessment: Pigmentation
Scar Pigment will be measured using the DSMII ColorMeter® (Cortex Technology, Hadsund, Denmark). The mean of three measurements of both the scar and healthy skin will be taken.
Timepoint [8] 342977 0
Measurement will be taken at each of the 3, 6 and 12 month post date of burn injury follow up visits.
Secondary outcome [9] 342978 0
Scar Assessment: Erythema
Scar Erythema will be measured using the DSMII ColorMeter® (Cortex Technology, Hadsund, Denmark). The mean of three measurements of both the scar and healthy skin will be taken.
Timepoint [9] 342978 0
Measurement will be taken at each of the 3, 6 and 12 month post date of burn injury follow up visits.
Secondary outcome [10] 342979 0
Scar Assessment: Lightness
Scar Lightness will be measured using the DSMII ColorMeter® (Cortex Technology, Hadsund, Denmark). The mean of three measurements of both the scar and healthy skin will be taken.
Timepoint [10] 342979 0
Measurement will be taken at each of the 3, 6 and 12 month post date of burn injury follow up visits.
Secondary outcome [11] 342981 0
Health Related Quality of Life: Economic evaluation of interventions The CHU9D is a preference based utility that will assess worry, sadness, pain, fatigue, annoyance, school work/homework, sleep, daily routine, and ability to join in activities. The preference weights from these are then converted to quality-adjusted life years 9 QALYs) for economic evaluation. This will be done by the caregivers for all participants.
Timepoint [11] 342981 0
Measurement will be taken at each of the 3, 6 and 12 month post date of burn injury follow up visits.
Secondary outcome [12] 342982 0
Health-related Quality of Life: Associated with Scar formation The BBSIP will be used to measure the intensity and frequency of sensations, such as pain, tightness and discomfort as well as health related quality of life specific to people with burn scars. This will be completed by the participant if aged eight years or older , and by the caregiver for all participants.
Timepoint [12] 342982 0
Measurement will be taken at each of the 3, 6 and 12 month post date of burn injury follow up visits.
Secondary outcome [13] 342983 0
Treatment Satisfaction: Caregiver
Treatment satisfaction will be measured using a self report 0 to 10 Numeric Rating Scales ( NRS) by the caregiver
Timepoint [13] 342983 0
After re-epithelialisation and on last review at 12 months post date of burn injury.
Secondary outcome [14] 342984 0
Treatment Satisfaction: Treating Staff
Treatment satisfaction will be measured using a self report 0 to 10 Numeric Rating Scales ( NRS) by treating staff.
Timepoint [14] 342984 0
After re-epithelialisation and on last review at 12 months post date of burn injury.
Secondary outcome [15] 342988 0
Health Resource Utilisation. Data will be recorded for each participant including trial interventions costs, labour time (e.g. occupational therapists, physiotherapist, nurses and surgeons), length of stay in hospital (omitting any additional occasions of social admission needs) and other burns related resource use ( e.g. splint, moulds).Demographic data will also collect information pertaining to cost. This will be determine using various tools including calculating difference between resource use and costs from hospital medical records, overheads and QALYs. A health economist is involved in this process.
Timepoint [15] 342988 0
At each dressing change and at the 3, 6, and 12 month post burn injury follow up visit
Secondary outcome [16] 346440 0
Adjunct Interventions: Distraction Techniques utilised prior to change of dressing will be noted.
Timepoint [16] 346440 0
At each dressing change until the wound is > 95% re-epithlialised.
Secondary outcome [17] 346441 0
Wound Intervention Fidelity Checklist. This will be completed for each arm of the trial to assess the adherence by clinical staff to the intervention protocol.
Timepoint [17] 346441 0
At baseline dressing application and subsequent dressing changes until the wound is > 95% re-epithelialised

Eligibility
Key inclusion criteria
1. Age = 16 years
2. Burn depth of superficial partial to mid-dermal thickness burns
3. Able to be recruited and treated within 48hours of burn injury
4. TBSA = 5%
Minimum age
No limit
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aged > 16 years
Burn depth of superficial , deep dermal or full thickness depth
2. TBSA < 5% TBSA
3. Patients whose injuries are deemed not compatible with life by the attending burns surgeon
4. Burns > 48hrs from time of injury

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)
Treating physicians/nursing staff of all children meeting the inclusion/exclusion criteria presenting to the Lady Cilento Children’s Hospital, Brisbane will determine eligibility for enrolment in the study. With the parent/caregivers permission an investigator aligned with the study will discuss the study with the parents/caregivers and seek informed consent within 48 hours of the burn injury occurring. Once informed consent is obtained, participants will be randomised to one of three treatment groups. Randomisation will be undertaken by use of a randomisation sequence embedded into the REDCap data collection application by a third party not aligned with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence will be verified by statistician before upload onto the REDCap software application.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be graphed and summary statistics calculated for all outcomes. Where appropriate, non-parametric tests will be used. A survival analysis will be utilised, with the time to healing as the main outcome and dressing group as the explanatory variable. A p value of 0.05 will be considered statistically significant. The sample size calculation, randomisation of cohort and statistical analysis will be finalised in consultation with a biostatistician.

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)
QLD
Recruitment hospital [1] 9731 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 18509 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298355 0
Commercial sector/Industry
Name [1] 298355 0
Avita Medical Asia Pacific
Address [1] 298355 0
AVITA MEDICAL ASIA PACIFIC
Suite G.01, 68 South Terrace,
South Perth, WA, 6151, Australia
Country [1] 298355 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St,
Brisbane City
QLD
4000
Country
Australia
Secondary sponsor category [1] 297716 0
Commercial sector/Industry
Name [1] 297716 0
Avita Medical
Address [1] 297716 0
AVITA MEDICAL ASIA PACIFIC
Suite G.01, 68 South Terrace,
South Perth, WA, 6151, Australia
Country [1] 297716 0
Australia
Other collaborator category [1] 280099 0
Individual
Name [1] 280099 0
Dr Zephanie Tyack
Address [1] 280099 0
Centre for Children's Burns and Trauma Research
Children's Health Research Centre
62 Graham Street, South Brisbane, QLD, 4101

The University of Queensland & Centre for Functioning and Health Research
Metro South Health
PO Box 6053, BURANDA QLD 4102

Country [1] 280099 0
Australia
Other collaborator category [2] 280100 0
Individual
Name [2] 280100 0
A/Prof Steven M. McPhail
Address [2] 280100 0
Institute of Health and Biomedical Innovation, Queensland University of Technology, 41 Blamey Street, Kelvin Grove Queensland 4059

Centre for Functioning and Health Research, Metro South Hospital and Health Service,
PO Box 6053, BURANDA QLD 4102
Country [2] 280100 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299350 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 299350 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct,
62 Graham St,
South Brisbane
QLD
4101
Ethics committee country [1] 299350 0
Australia
Date submitted for ethics approval [1] 299350 0
20/11/2017
Approval date [1] 299350 0
21/12/2017
Ethics approval number [1] 299350 0
HREC/17/QRCH/278

Summary
Brief summary
The RECELL® autologous skin suspension system enables rapid autologous epidermal replacement. The dearth of data substantiating its implementation in acute paediatric burn injuries warrants further evaluation. This study aims to compare three commercially available burn wound management interventions used for burn injuries to identify the most effective method. Informed consent of parent/guardians of children meeting the inclusion criteria will be obtained. Participants will be randomised to one of three groups: standard silver dressing, Biobrane® with /out RECELL®. These will be applied under a general anaesthetic in the operation theatre. Initial visit details regarding total body surface area, participant demographics will be obtained from participant and parent/caregiver. Laser Doppler imaging (LDI) will determine the burn depth on first dressing change at day three post injury. On subsequent 3-5 day dressing changes until wound is > 95% re-epithelialised and at outpatient follow up at 3,6 and 12 months post injury, data acquisition will be from 3D photography, LDI, ultrasound, colorimetry and assessments of pain, itch, and pigmentation, ease of treatment, fidelity checklist , adjunct intervention, demographic data, cost and patient satisfaction will also be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80146 0
Prof Roy Kimble
Address 80146 0
Service Group Director, Paediatric Surgery, Urology, Neonatal Surgery, Burns & Trauma
Clinical Lead, Paediatric Vascular Anomalies,
Director of the Centre for Children’s Burns & Trauma Research
University of Queensland Professor of Paediatrics & Child Health
PO Box 3474, South Brisbane, Qld, 4101

Country 80146 0
Australia
Phone 80146 0
+61 7 3068 5624
Fax 80146 0
+61 7 30683799
Email 80146 0
royk@uq.edu.au
Contact person for public queries
Name 80147 0
Dr Bronwyn Griffin
Address 80147 0
Clinical Research Manager
Centre for Children's Burns and Trauma Research, QUT
Lady Cilento Children's Hospital, South Brisbane, Queensland, 4101
.
Country 80147 0
Australia
Phone 80147 0
+61730697392
Fax 80147 0
Email 80147 0
b.griffin@uq.edu.au
Contact person for scientific queries
Name 80148 0
Dr Bronwyn Griffin
Address 80148 0
Clinical Research Manager
Centre for Children's Burns and Trauma Research,QUT
Lady Cilento Children's Hospital, South Brisbane, Queensland, 4101
Country 80148 0
Australia
Phone 80148 0
+61730697392
Fax 80148 0
Email 80148 0
b.griffin@uq.edu.au

No data has been provided for results reporting
Summary results
Not applicable