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Trial registered on ANZCTR


Registration number
ACTRN12613001342707
Ethics application status
Approved
Date submitted
4/09/2013
Date registered
9/12/2013
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cultured Epithelial Autografts for massive burns patients
Scientific title
Evaluation of graft take rates in adults with burns exceeding 35% total body surface area receiving cultured epithelial autografts
Secondary ID [1] 283137 0
nil
Universal Trial Number (UTN)
U1111-1147-5937
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burns injury exceeding 35% total body surface area 289990 0
Condition category
Condition code
Injuries and Accidents 290372 290372 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous split skin grafts (SSG) remain the gold standard for management of patients with massive burns. However, autografts become insufficient to cover burn wounds when the total body surface area (TBSA) involved exceed thirty-five percent.

The application of Cultured Epithelial Autograft (CEA) technology involves taking a skin sample from the burns patient, culturing and expanding the skin cells before re-applying the end product to cover the burn wounds in the same patient.

The skin sample consists of an elliptical full thickness skin biopsy (2x5cm) harvested from a hair-bearing area such as groin, axilla or scalp. In certain circumstances where it is not feasible to take a full thickness skin sample from the participant for processing (ie donor hair-bearing areas such as groin, axilla and scalp are involved in the burn injury), a 2x5cm split skin biopsy may be taken (with a dermatome) instead from an available and appropriate region. Harvesting of the skin sample is anticipated to take no longer than 10-20 minutes.

The exact timing of CEA application depends on factors such as wound bed preparation and patient stability. However, CEA manufactured from our Skin Culture Laboratory is ready to be applied approximately 14 days after the initial skin biopsy.

All the patients will receive autologous split skin grafts, the gold standard for management of patients with massive burns. Prepared wound beds are closed as much as possible with meshed autologous split skin grafts, in particular, difficult areas susceptible to shear forces and poor graft take (posterior trunk) or areas susceptible to joint contractures (joint flexures, hands).

The exact quantity of CEA produced and used in any particular patient depends on the individual clinical requirements, rate of expansion and production capabilities of the clinical laboratory.
Intervention code [1] 287865 0
Treatment: Surgery
Comparator / control treatment
NO comparator/ control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290401 0
CEA take rate via clinical assessment by senior burn surgeons
Timepoint [1] 290401 0
3-5 days after surgery
7-10 days after surgery
4 weeks after surgery
6 months after surgery
12 months after surgery
at time of hospital discharge
Secondary outcome [1] 304429 0
mortality rate
Timepoint [1] 304429 0
1 year after discharge
Secondary outcome [2] 304747 0
scar quality (Vancouver Scar Scale)
Timepoint [2] 304747 0
1 year after discharge
Secondary outcome [3] 304748 0
complications ie infection, CEA loss (via clinical assessment by senior burn surgeons, microbiological assessment of wound beds)
Timepoint [3] 304748 0
1 year after discharge
Secondary outcome [4] 304749 0
length of hospital stay (via clinical assessment by senior burn surgeons)
Timepoint [4] 304749 0
at hospital discharge

Eligibility
Key inclusion criteria
Inclusion criteria include adult patients (18-70 years of age) with burns exceeding 35% TBSA admitted to the Victorian Adult Burns Service at The Alfred (tertiary referral burns centre).
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients less than 18 years of age or more than 70 years of age.

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)
This study is designed as a small prospective clinical trial projected to recruit participants for three years starting late 2013. Adult patients (18-70 years of age) with burns exceeding 35% TBSA admitted to the Victorian Adult Burns Service at The Alfred are potential participants. Verbal discussions held as soon as possible with the potential participant or the person responsible (if the potential participant is not able to provide informed consent) is supplemented by written consent (the relevant Participant Information Sheet/ Consent Form). Consent is mandatory for recruitment and participation in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
-
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot study expecting to recruit approximately six patients per year. As a small prospective cohort study, results are unlikely to reach statistical significance.

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment hospital [1] 1476 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7310 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 287889 0
Hospital
Name [1] 287889 0
Alfred Health
Address [1] 287889 0
55 Commercial Road, Prahran, Victoria 3181
Country [1] 287889 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Prahran, Victoria 3181
Country
Australia
Secondary sponsor category [1] 286617 0
None
Name [1] 286617 0
Address [1] 286617 0
Country [1] 286617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289830 0
Alfred Health
Ethics committee address [1] 289830 0
55 Commercial Road, Prahran, Victoria 3181
Ethics committee country [1] 289830 0
Australia
Date submitted for ethics approval [1] 289830 0
04/09/2013
Approval date [1] 289830 0
10/12/2013
Ethics approval number [1] 289830 0

Summary
Brief summary
In this proof of concept study, we aim to demonstrate that CEA may be successfully produced from our laboratory and used in the clinical setting. With our strategy in the application of CEA sheets, we can match or better the quality of care previously provided by our unit, and other burn centres around the world.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42638 0
Miss Heather Cleland
Address 42638 0
Director
Victorian Adult Burns Service
Alfred Health
55 Commercial Rd
Prahran
Victoria 3181
Country 42638 0
Australia
Phone 42638 0
+61 03 90763626
Fax 42638 0
+61 03 90765568
Email 42638 0
burnsunit@alfred.org.au
Contact person for public queries
Name 42639 0
Mr Cheng Hean Lo
Address 42639 0
Victorian Adult Burns Service
Alfred Health
55 Commercial Rd
Prahran
Victoria 3181
Country 42639 0
Australia
Phone 42639 0
+61 03 90763626
Fax 42639 0
+61 03 90765568
Email 42639 0
clo@plasticsurgery.org.au
Contact person for scientific queries
Name 42640 0
Mr Cheng Hean Lo
Address 42640 0
Victorian Adult Burns Service
Alfred Health
55 Commercial Rd
Prahran
Victoria 3181
Country 42640 0
Australia
Phone 42640 0
+61 03 90763626
Fax 42640 0
+61 03 90765568
Email 42640 0
clo@plasticsurgery.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary