Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002003257
Ethics application status
Approved
Date submitted
6/12/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Full-thickness cultured skin to heal significant burns without needing skin grafts
Scientific title
A prospective evaluation of Cultured Composite Skin (CCS) as a definitive closure second stage [where biodegradable polyurethane dermal matrix (BTM) represents the first stage] in the management of extensive deep burn injury.
Secondary ID [1] 296822 0
CCS/01/2016 (Sponsor study reference number)
Universal Trial Number (UTN)
U1111-1225-1616
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Significant burns (Full-thickness burn injuries between 30% and 100% Total Body Surface Area) 310707 0
Condition category
Condition code
Injuries and Accidents 309408 309408 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective, 5 patient, non-controlled, non-blinded, single-arm pilot efficacy trial involving participants ranging from those with life-threatening burn injuries, up to and including those meeting the criteria for non-survivable burn injury (where this treatment offers the only chance of survival). All treatments will be administered during the participant's inpatient admission to the Royal Adelaide Hospital. At the first operation in the operating theatre, under general anaesthesia, the participant will have ALL deep burn excised.The operative area will be aggressively scrubbed with betadine-impregnated brushes, wet and dry Raytek gauze packs to clean the burns, remove all surface contaminants, loose non-viable material, etc. and shaved of hair. Skin preparation will be with Betadine™ (povidone iodine solution), unless the subject has a demonstrated history of iodine sensitivity/allergy when alcoholic chlorhexidine solution will be used. After draping, and under aseptic conditions, the deep areas of burn will be outlined for excision using a Sommerlad pen and Bonney’s Blue ink. The deep burn will be tumesced subcutaneously with a solution of 1:500,000 adrenaline and 0.05% bupivacaine to reduce intraoperative blood loss and post-operative pain. The burn will then be excised with a Watson-Humby knife to viable tissue. Haemostasis will be secured by bipolar diathermy and adrenaline-soaked packs (1:10,000). A biopsy (split skin graft) 10cm x 20cm harvested from unburned skin to create the autologous Composite Cultured Skin (CCS). This will be grown over the next 5 weeks. After this debridement, the wounds will be 'passively' temporised with an epidermal skin substitute (Biobrane). This will be overdressed with Acticoat, held by crepe bandages (limbs) or adhesive tapes (trunk).

At a second operation (two or three days after the first operation also under general anaesthesia in theatre), the Biobrane will be removed, the wounds refreshed and BTM will be applied to all deep areas, except face, soles of feet and palms of hands. feet and hands. The BTM will be held in place with surgical steel staples. Overdressing will be with Acticoat™ nanocrystalline silver dressing held with hypafix on the trunk and crepe bandages on the limbs. Once recovered from anaesthesia, the patient will be returned to the ward, or Intensive Care Unit as required. The dressings will be taken down every three days for inspection. Evidence of material integration (colour, loss of foam pattern, general appearance) will be sought and recorded. Digital photographs will be taken. Staples will be removed at BTM delamination and CCS application. Dressing changes will occur on the ward every three days until the BTM is integrated and the CCS is ready for transplantation (about 5 weeks after the first operation) and the third operation is performed where the seal of the BTM is removed and the CCSs are applied, fixed and dressed under general anaesthetic. Dressings are again every three days until healing. The surgeries will all be performed by a specialist plastic surgery-trained burns surgeon with at least 10 years specialist burn surgery experience, with junior staff and theatre nurses. The intervention should need only one application, although in larger cases, some additional touch-up applications may be required. With burn injuries of this severity, early surgery is performed under two doctor, or third party consent. However, the participant is expected to be awake, cognisant and responsible by the time the CCS is ready for transplantation. At that stage, involvement in the trial will be discussed and information sheets provided to participant, next of kin and other family regarding the trial treatment, before informed consent is obtained, or involvement in the trial is refused.
Intervention code [1] 313105 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308356 0
CCS ‘take’ (this will be assessed clinically and by punch biopsy once epithelialisation becomes apparent – in pig trials this occurred between Day 7-10)
Timepoint [1] 308356 0
28 days post-CCS application (approximately 9 weeks post-injury)
Primary outcome [2] 308374 0
Ratio of CCS take:loss (if there is partial loss/failure of CCS, this ratio can be calculated, knowing the size (area) of the CCS pieces (each piece is 25 x 25cm).
Timepoint [2] 308374 0
28 days post-CCS application (approximately 9 weeks post-injury)
Secondary outcome [1] 354718 0
Scar quality after healing of the split skin graft (demonstrated by Matching Assessment using Photographs with Scars - MAPS). Baseline to be taken post-BTM integration, pre-CCS application; final measurement at 12 months post-CCS application.
Timepoint [1] 354718 0
12 months post-CCS application
Secondary outcome [2] 354787 0
Therapist and patient satisfaction with outcome (demonstrated by a therapist delivered, patient orientated outcome scale - the Patient and Observer Scar Assessment Scale v.2 (POSAS)). Baseline to be taken post-BTM integration, pre-CCS application; final measurement at 12 months post-CCS application.
Timepoint [2] 354787 0
12 months post-CCS application

Eligibility
Key inclusion criteria
• Patients with deep (deep dermal or full thickness burns), between 30% and 100% (inclusive) of their total body surface area (TBSA) requiring split skin grafting.

Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy/Lactation
• Non-English speakers (from an informed consent perspective), unless an information and consent form in the subject’s language is available along with a study coordinator capable of answering questions in that language.
• Known allergy/previous reaction to polyurethane dressing materials
• Unwillingness to consent, or unwillingness of next of kin (NOK) or immediate family to provide consent.

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)
Not applicable
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
Data will be collected up to 12 months post-injury. Participant/carers will be advised to massage and moisturize the healed burn areas with aqueous moisturizing creams at least three times a day in the early follow-up and reducing to once a day by 1 year post-graft application. Scar modulation with compression garments will be provided and continued until maturation is advanced. Physiotherapy and occupational therapy will commence early and be aggressive, providing additional scar modulation with silicone sheeting where necessary. Therapy assessment of MAPS, joint ROM and POSAS should be made at 3, 6 and 12 months, although only the 12 month record forms a secondary outcome measure. Digital photography of progress, with video where results are deemed interesting or important, will be taken at each of these therapy reviews. Therapy/medical review is likely to be more frequent - if a feature of healing or outcome is felt to be important, or interesting, it should also be recorded photographically.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The small pilot sample size and proof-of-concept nature of the trial, preclude in-depth statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12670 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 25092 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301394 0
Government body
Name [1] 301394 0
The Lifetime Support Authority
Country [1] 301394 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Skin Tissue Engineering Pty Ltd
Address
PO Box 469, Unley, SA 5061
Country
Australia
Secondary sponsor category [1] 301079 0
None
Name [1] 301079 0
Address [1] 301079 0
Country [1] 301079 0
Other collaborator category [1] 280456 0
Hospital
Name [1] 280456 0
Royal Adelaide Hospital
Address [1] 280456 0
1, Port Road, Adelaide 5000, South Australia
Country [1] 280456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302139 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 302139 0
Ethics committee country [1] 302139 0
Australia
Date submitted for ethics approval [1] 302139 0
15/05/2018
Approval date [1] 302139 0
24/07/2018
Ethics approval number [1] 302139 0
HREC/18/CALNH/322

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89226 0
Prof John E Greenwood AM
Address 89226 0
Director, Adult Burn Service, Royal Adelaide Hospital, Port Road, Adelaide 5000, South Australia, AUSTRALIA,

Country 89226 0
Australia
Phone 89226 0
+61 487 234243
Fax 89226 0
Email 89226 0
[email protected]
Contact person for public queries
Name 89227 0
John E Greenwood AM
Address 89227 0
Director, Adult Burn Service, Royal Adelaide Hospital, Port Road, Adelaide 5000, South Australia, AUSTRALIA.
Country 89227 0
Australia
Phone 89227 0
+61 487 234243
Fax 89227 0
Email 89227 0
[email protected]
Contact person for scientific queries
Name 89228 0
John E Greenwood AM
Address 89228 0
Director, Adult Burn Service, Royal Adelaide Hospital, Port Road, Adelaide 5000, South Australia, AUSTRALIA,

Country 89228 0
Australia
Phone 89228 0
+61 487 234243
Fax 89228 0
Email 89228 0
[email protected]

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?

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.