ANZCTR - Registration

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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

24/03/2024

Date data sharing statement initially provided

6/08/2019

Date results provided

24/03/2024

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 superficial partial to mid dermal thickness burn

Secondary ID [1]

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

Condition category

Condition code

Injuries and Accidents

Burns

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The initial dressing application will be conducted under a general anaesthetic within 48 hours of the burn injury. All participants will undergo a non-excisional debridement and cleaning with QV Wash prior to dressing application.

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 the manufacturer’s recommendations. A layer of Biobrane® (Smith & Nephew Medical Ltd, Hull, UK) will be laid over the top of the RECELL® and the 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), and crepe bandage; 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 detached from the neo-epithelium.

DONOR SITE: The 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 inert standard dressing as per surgeon preference.

ARM 3: Once the wound bed is sufficiently prepared the surgeon will apply a layer of Biobrane® over the burn, which will be secured with Hypafix®. Over the top of the Biobrane® will be a layer of Jelonet® then Kerlix®, Crepe bandage; secured by Hypafix®. The Jelonet®, Kerlix®, crepe bandage 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]

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]

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]

Days to Re-epithelialisation:
The number of days from date of burn injury to 95% or more wound re-epithelialisation or date of skin graft as determined by the attending burns surgeon.

Secondary outcome [1]

Pain:
Pain will be assessed using Faces Pain Scale-Revised by participants older than 5 years); Numeric Rating Scale-Pain (NRS-P Proxy by all patients and NRS-P by participants older than 8-years) and the Faces, Legs, Activity Cry, Consolability (FLACC by nursing staff).

Timepoint [1]

At initial dressing application and each dressing change (before and after dressing removal then before and after dressing application) until 95% or more wound re-epithelialisation as determined by the attending burns surgeon.

Secondary outcome [2]

Ease of Dressing Application:
Dressing application ease will be assessed using a survey regarding the interventions by the burns clinicians.

Timepoint [2]

After each dressing change until 95% or more wound re-epithelialisation as determined by the attending burns surgeon.

Secondary outcome [3]

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]

At initial dressing application and each dressing change until 95% or more wound re-epithelialisation as determined by the attending burns surgeon.

Secondary outcome [4]

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% or more re-epithelialised. Chronic itch intensity will be measured using the itch items of the Patient and Observer Scar Assessment Scale (POSAS) and (Brisbane Burn Scar Impact Profile) BBSIP instruments.

Timepoint [4]

Acute Itch: at all change of dressing until the wound is 95% or more re-epithelialized as determined by the attending burns surgeon.
Chronic Itch: at the 3, 6, and 12 months post date of burn injury follow up visit

Secondary outcome [5]

Adverse Event/Discontinuation:
Minimal adverse events are expected from the proposed interventions. At the study centre, known potential adverse events (e.g. infection, haematoma, intensive care admissions) have a standardised management protocol. Adverse events related to the interventions will be monitored through review of patient medical records, by guardian and participant (where applicable) self-report and by the treating clinicians. All adverse events will be communicated to the clinical health service and Human Research Ethics Committee (HREC). Discontinuation or alteration of treatment will be at the discretion of the treating clinical team. An independent Safety Monitoring Group will also monitor all aspects of patient safety throughout the study on a regular basis. After a minimum of 30 participants have been recruited,an independent statistician (blinded to the treatment allocation) will complete an interim analysis.

Timepoint [5]

Through the study at any specific time.
Last possible assessment will be at 12 months post date of burn injury.

Secondary outcome [6]

Scar Assessment: Scar thickness.
Scar thickness will be measured using the Venue40 (GE Healthcare, Fairfield, CT, USA). ultrasound machine. An average of three measurements will be recorded and used in the analysis.

Timepoint [6]

This measurements will be taken at 3 ,6 and 12 months post date of burn injury.

Secondary outcome [7]

Scar Assessment: Subjective Severity.
Subjective scar severity will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS) by a burns clinician, caregivers of all participants and by the self-report of participants aged 8 years and over.

Timepoint [7]

This measurements will be taken at 3 ,6 and 12 months post date of burn injury.

Secondary outcome [8]

Scar Assessment: Pigmentation(b*).
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]