Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000349640
Ethics application status
Approved
Date submitted
11/03/2023
Date registered
5/04/2023
Date last updated
5/04/2023
Date data sharing statement initially provided
5/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Wound healing and scarring assessment following application of bioengineered skin in burn patients
Scientific title
Safety and performance of full thickness burn wound closure using bioengineered skin on patients with greater than 20% total body surface burn injury: A feasibility study assessing incidence of adverse device effects, and percentage take rate of applied human skin equivalent.
Secondary ID [1] 308994 0
Nil known
Universal Trial Number (UTN)
Trial acronym
B.E.A.S.T: Biologically Engineered Autologous Skin Treatment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn injury 329023 0
Condition category
Condition code
Injuries and Accidents 326005 326005 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two treatments being assessed are 1. bioengineered human skin equivalent (HSE) incorporating platelet derived hydrogel, and 2. bioengineered HSE using polyurethane polymer.
The main difference between the two HSE treatments are 1. HSE using platelet hydrogel, which is made with platelets which are supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process; and 2. HSE using NovoSorb polyurethane polymer, which is a biodegradable foam, which is widely used in the treatment of burn injury.
The participants will receive either one or both treatments to their burn injuries. This is an open label study where the areas treated are known to the investigators, and the areas treated with HSE will be determined by clinician's discretion.
Treatment will occur in the Alfred Hospital's Operating Suite by a Burns Surgeon, and HSE may be applied on more than once occasion if there is a complication which results in the initial HSE failing to take.
The length of time taken for HSE application will vary from patient to patient, and will be determined by the extent of their burn injury and the number of HSE grafts applied.
Follow up is at 7-10 days, 4 weeks, 6 months and 12 months post HSE application.
Intervention code [1] 325436 0
Treatment: Other
Intervention code [2] 325437 0
Treatment: Surgery
Comparator / control treatment
Sites adjacent to the HSE treated sites, will be treated with autologous split skin grafts. This is standard treatment of burn injury, and involves taking intact skin from an uninjured area of the patient, and surgically applying it to a burn injured site.
Control group
Active

Outcomes
Primary outcome [1] 333913 0
Primary performance outcome is the percentage take rate of applied HSE (area healed as a percentage of areas grafted) which will be assessed at clinical review by wound measurements, and with progressive clinical photographs, for direct comparison.
Timepoint [1] 333913 0
7-10 days post closure with HSE
1 month post closure with HSE
6 months post closure with HSE
12 months post closure with HSE
Primary outcome [2] 333914 0
Primary safety outcome is the incidence of adverse device effects (ADEs) collected throughout the clinical investigation. These will be assessed via clinician review, reviewing electronic medical records and by participant self-reporting throughout the study. Examples of possible adverse events include failure of HSE to integrate or achieve wound closure, infection, rash, discomfort or itch, serous fluid or blood under HSE, wound or joint contraction.
Timepoint [2] 333914 0
Duration of study: Adverse device events will be recorded at any time throughout the study, for a maximum of 12 months post burn injury closure with HSE.
Secondary outcome [1] 418722 0
Infection rate (%) of treated sites will be assessed by clinical review, and wound swabbing when deemed necessary at the clinician's discretion.
Timepoint [1] 418722 0
7-10 days post closure with HSE
1 month post closure with HSE
6 months post closure with HSE
12 months post closure with HSE
Secondary outcome [2] 418723 0
Scar quality assessed using Vancouver Scar Scale (VSS) and Patient and Observer Scar Assessment Scale (POSAS). This will be assessed as a composite outcome.
Timepoint [2] 418723 0
6 months post closure with HSE
12 months post closure with HSE
Secondary outcome [3] 418724 0
Wound contraction, measured and calculated as a percentage (%) of surface area initially treated with HSE. This will be assessed via clinician review, wound measurements and clinical photography.
Timepoint [3] 418724 0
6 months post closure with HSE
12 months post closure with HSE
Secondary outcome [4] 418725 0
Biopsy taken from wounds for qualitative histological and genetic analysis. this will be assessed as a composite outcome.
Timepoint [4] 418725 0
Following burn excision
Prior to closure with HSE
7-10 days post closure with HSE
Secondary outcome [5] 418726 0
All treatment sites are documented photographically to assess the physical appearance of wounds.
Timepoint [5] 418726 0
Day 0 (day of closure with HSE)
7-10 days post closure with HSE
1 month post closure with HSE
6 months post closure with HSE
12 months post closure with HSE
Secondary outcome [6] 418727 0
Secondary safety outcome is the incidence of adverse events (AEs) collected throughout the clinical investigation. These will be assessed via clinician review, reviewing medical records, and participant self- reporting of events. These could be any event assessed by clinicians as being possibly or probably related to the application of HSE such as bleeding, pain, introduction of infection.
Timepoint [6] 418727 0
Duration of study: Adverse events will be recorded at any time throughout the study for a maximum of 12 months post burn injury closure with HSE.

Eligibility
Key inclusion criteria
(1) Patient suffering thermal deep dermal or full thickness burn injuries involving >20% total body surface area (TBSA) requiring excision and grafting.
(2) Patient aged 18-70 years of age.
(3) Patient has deep dermal or full thickness burn injuries on anterior trunk, upper and/or lower limbs (non-weight bearing and not over joints)
(4) Patient agrees to all required follow up procedures and visits.
(5) Patient or legal representative provides written informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patient with burns solely confined to the following excluded anatomical sites: palms, back of trunk, face, neck and soles of feet.
(2) Females who are pregnant or breastfeeding.
(3) Patient with a history of allergy or previous reaction to polyurethane dressing materials, relevant antimicrobial agents or materials of bovine or murine origin.
(4) Patient with severe burn injury and high risk of death.
(5) Patient with a concomitant medical condition with a life expectancy of less than 12 months ie advanced malignancy.
(6) Patient with a pre-existing infection which may interfere with the integration of HSE.
(7) Patient who has expressed a refusal to participate.
(8) Patients who are participating in another clinical trial which has the potential to affect the outcome of this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The pragmatic sample size calculation (n=10) is based on the study being a feasibility study (phase I) investigating safety and efficacy of bioengineered HSE. It also takes into account the anticipated number of potential participants available for recruitment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24074 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39582 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313206 0
Government body
Name [1] 313206 0
National Health and Medical Research Council (NHMRC)
Country [1] 313206 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 314922 0
None
Name [1] 314922 0
Address [1] 314922 0
Country [1] 314922 0
Other collaborator category [1] 282566 0
University
Name [1] 282566 0
Monash University
Address [1] 282566 0
Wellington Road
Clayton VIC 3800
Country [1] 282566 0
Australia
Other collaborator category [2] 282572 0
Charities/Societies/Foundations
Name [2] 282572 0
Australian Red Cross Lifeblood
Address [2] 282572 0
Level 3
417 St Kilda Road
Melbourne VIC 3004
Country [2] 282572 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312437 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 312437 0
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 312437 0
Australia
Date submitted for ethics approval [1] 312437 0
04/10/2022
Approval date [1] 312437 0
12/01/2023
Ethics approval number [1] 312437 0
HREC/76530/Alfred-2022

Summary
Brief summary
The purpose of the study is to assess a new type of closure for deep burn injury. It will evaluate the safety and efficacy of bioengineered human skin equivalent (HSE) for the closure of full thickness wounds in burn patients requiring excision and skin grafting, and will compare the outcomes with areas treated with standard split skin grafting.
HSE is skin which is constructed in a laboratory, using skin cells, which have been extracted from a participant’s skin sample. This project involves using and comparing two variations of the HSE, as well as using standard burns treatment, and assessing the outcomes. The participant may receive one or both variations of the HSE, and will also receive split skin grafting to some of their burns. The three different possible treatments for the participant's burn wounds are:
• HSE using platelet hydrogel, which is made with platelets supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process. These are combined with a hydrogel, which is a water soluble sheet used to grow the skin cells.
• HSE using Novosorb® polyurethane polymer, which is a biodegradable foam, widely used in the treatment of burns.
• The remaining burn areas will be treated with split skin grafts. The participant will have skin grafts applied to some of their burn injuries.
The treated areas are subsequently assessed and photographed at 7-10 days post HSE application, 4 weeks post HSE application, 6 months post HSE application, and 12 months post HSE application.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124666 0
A/Prof Heather Cleland
Address 124666 0
Victorian Adult Burns Service
Ward 6 West
55 Commercial Road
Melbourne VIC 3004
Country 124666 0
Australia
Phone 124666 0
+610390763626
Fax 124666 0
Email 124666 0
h.cleland@alfred.org.au
Contact person for public queries
Name 124667 0
A/Prof Heather Cleland
Address 124667 0
Victorian Adult Burns Service
Ward 6 West
55 Commercial Road
Melbourne VIC 3004
Country 124667 0
Australia
Phone 124667 0
+610390763626
Fax 124667 0
Email 124667 0
h.cleland@alfred.org.au
Contact person for scientific queries
Name 124668 0
A/Prof Shiva Akbarzadeh
Address 124668 0
Victorian Adult Burns Service
Skin Bioengineering Laboratory
99 Commercial Road
Melbourne VICTORIA 3004
Country 124668 0
Australia
Phone 124668 0
+610399030616
Fax 124668 0
Email 124668 0
shiva.akbarzadeh@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To ensure patient privacy, data will be collated prior to being available for viewing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.