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Trial registered on ANZCTR


Registration number
ACTRN12613001375741
Ethics application status
Approved
Date submitted
11/12/2013
Date registered
16/12/2013
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a biodegradable polyurethane dermal matrix in the management of deep burn injury.
Scientific title
Biodegradable Temporising Matrix (BTM) in dermal replacement and wound temporisation prior to definitive split-skin grafting post-excision of full thickness burns affecting between 20% and 50% of the total body surface area (TBSA) to assess integration, delamination and ability to support subsequent graft take.
Secondary ID [1] 283759 0
Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) Number - 343/2013.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep-dermal and full thickness burn injury (ie burns which require surgical excision and repair) involving between 20% and 50% of the total body surface area (TBSA). 290734 0
Condition category
Condition code
Skin 291096 291096 0 0
Other skin conditions
Surgery 291097 291097 0 0
Other surgery
Injuries and Accidents 291113 291113 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once the non-viable burned skin/tissue is excised surgically, the BTM will be surgically implanted into the healthy wound bed and held with surgical staples before being over-dressed. Dressing changes every three days will allow observaton and monitoring of the progress of integration of the dermal component (a biodegradable polyurethane foam). After 3 - 6 weeks, following complete integration of the permanent 'dermal' component of the material, its temporary 'epidermal component (a bonded, superficial, non-biodegradable polyurethane film) will be removed, the underlying 'neodermal' surface refreshed by dermabrasion and definitive closure afforded by the application of a thin, split-thickness skin graft. Graft take and subsequent quality will form long-term outcomes
Intervention code [1] 288446 0
Treatment: Devices
Intervention code [2] 288447 0
Treatment: Surgery
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291081 0
Ability of the dermal component of the BTM to integrate into the wound. The BTM is a white foam bonded to a transparent seal, integration is obvious by observations of colour (red), texture (homogeneous and lacking the initial foam appearance through the seal) and opacity (bed structures such as tendons become completely obscured by the overlying integrated BTM).
Timepoint [1] 291081 0
3 - 6 weeks
Primary outcome [2] 291082 0
Ease of delamination of the temporary epidermal seal from the integrated dermal matrix. At the time of delamination, ease will be determined by the removal of the lamina (seal) in one piece and in one action. Fragmentation and piecemeal removal would, for example, be seen as a failure.
Timepoint [2] 291082 0
3 - 6 weeks
Primary outcome [3] 291083 0
Ability of the integrated dermal component to receive a split skin graft and to then support split skin graft take. Split skin grafts are usually vascularised by inosculation within 48 hours. Take in this context is defined as adhesion of the graft by scar tissue and revascularisation by inosculation by 72 hours and is assessed by colour, blanching and real-time video VivoScopy.
Timepoint [3] 291083 0
3 - 6 weeks
Secondary outcome [1] 305982 0
Degree of wound contraction (function). In such large wounds, this can only be assessed in terms of major joint function (range of motion) and in the hand by the Michigan Hand Questionnaire.
Timepoint [1] 305982 0
12 - 18 months.
Secondary outcome [2] 305983 0
Cosmetic appearance compared to historical experience. This will include patient rating of scars.
Timepoint [2] 305983 0
12 - 18 months.

Eligibility
Key inclusion criteria
Deep (deep-dermal and full-thickness) burn injuries between 20 and 50% TBSA requiring burn excision and split skin grafting
Age between 18 and 70 years inclusive
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Unable to provide informed consent
Known allergy/previous reaction to polyurethane dressings

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)
All patients meeting inclusion and no exclusion criteria will be assessed for inclusion in the study. The nature of the trial will be discussed and signed consent obtained if the patient is willing to be involved.
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
Safety/efficacy
Statistical methods / analysis
This is a pilot study designed to assess the properties of the BTM in a large burn model. As such, only 5 patients are to be recruited, since sufficient data will be generated to provide confidence to progress to multi-centre human trials. Most analysis will thus be based on clinical observation (material integration, graft take, etc). Some statistical analysis may be appropriate to compare the treatment group with historical controls in terms of certain outcomes (Michigan Hand Questionnaire, joint range of motion, etc).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
2/12/2015
Date of last data collection
Anticipated
Actual
2/12/2016
Sample size
Target
5
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1856 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7639 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 288425 0
Commercial sector/Industry
Name [1] 288425 0
PolyNovo Biomaterials Pty Ltd
Country [1] 288425 0
Australia
Primary sponsor type
Hospital
Name
The Royal Adelaide Hospital
Address
North Terrace, Adelaide 5000, South Australia
Country
Australia
Secondary sponsor category [1] 287130 0
Commercial sector/Industry
Name [1] 287130 0
PolyNovo Biomaterials Pty Ltd
Address [1] 287130 0
Unit 2, 320 Lorimer Street,
Port Melbourne 3207, Victoria, Australia
Country [1] 287130 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290301 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 290301 0
Ethics committee country [1] 290301 0
Australia
Date submitted for ethics approval [1] 290301 0
Approval date [1] 290301 0
01/11/2013
Ethics approval number [1] 290301 0
Protocol Number - 121125.

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

Contacts
Principal investigator
Name 44950 0
A/Prof John E Greenwood
Address 44950 0
Adult Burn Centre,
Royal Adelaide Hopspital, North Terrace, Adelaide 5000, South Australia, Australia
Country 44950 0
Australia
Phone 44950 0
+61 8 8222 2233
Fax 44950 0
+61 8 8222 5676
Email 44950 0
john.greenwood@health.sa.gov.au
Contact person for public queries
Name 44951 0
John E Greenwood
Address 44951 0
Adult Burn Centre,
Royal Adelaide Hopspital, North Terrace, Adelaide 5000, South Australia, Australia
Country 44951 0
Australia
Phone 44951 0
+61 8 8222 2233
Fax 44951 0
+61 8 8222 5676
Email 44951 0
john.greenwood@health.sa.gov.au
Contact person for scientific queries
Name 44952 0
John E Greenwood
Address 44952 0
Adult Burn Centre,
Royal Adelaide Hopspital, North Terrace, Adelaide 5000, South Australia, Australia
Country 44952 0
Australia
Phone 44952 0
+61 8 8222 2233
Fax 44952 0
+61 8 8222 5676
Email 44952 0
john.greenwood@health.sa.gov.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIExperience with a synthetic bilayer Biodegradable Temporising Matrix in significant burn injury2018https://doi.org/10.1016/j.burnso.2017.08.001
N.B. These documents automatically identified may not have been verified by the study sponsor.