Trial registered on ANZCTR


Trial ID
ACTRN12615000405516
Ethics application status
Approved
Date submitted
17/04/2015
Date registered
30/04/2015
Date last updated
21/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a synthetic temporary dermal skin substitute for dermal repair after deep burn injury.
Scientific title
A prospective, non-controlled study to evaluate the safety and efficacy of synthetic NovoSorb Biodegradable Temporising Matrix (BTM) for the treatment of patients with deep burns.
Secondary ID [1] 286533 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep burns 296499 0
Condition category
Condition code
Skin 295041 295041 0 0
Other skin conditions
Surgery 295042 295042 0 0
Other surgery
Injuries and Accidents 295043 295043 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BTM wound dressing is composed of polyurethane materials, 2mm in thickness and is available in multiple sizes.

A qualified surgeon will administer the following procedures:
The wound bed must be cleaned with no devitalized tissue present. The BTM foam side is pressed into the wound, held with surgical steel staples and then applied with overlying dressing and crepe bandages. Dressings are changed every 3-5 days.
The BTM may be ready for grafting by 3-5 weeks. The BTM membrane is removed (delamination) leaving foam remnants attached to its underside. The wound is refreshed by gentle demabrasion until gently bleeding surface is obtained. A split skin graft is secured to the surface of BTM with staples or sutures and dressed.

Intervention code [1] 291624 0
Treatment: Surgery
Intervention code [2] 291625 0
Treatment: Devices
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294807 0
Rate (percentage area) of split skin graft (SSG) take over BTM within 7-10 days after grafting as a proportion of the total amount of BTM applied, per lesion, observed visually.
Timepoint [1] 294807 0
7-10 days after SSG
Secondary outcome [1] 314095 0
The rate (%) of BTM “take” at the time of skin grafting, as a proportion of the amount of BTM implanted, per lesion. BTM “take” is assessed by adherence, colour, loss of foam pattern and vascularisation.
Timepoint [1] 314095 0
At time of skin grafting using SSG
Secondary outcome [2] 314096 0
Degree of wound contraction measured by counting squares on a grid overlay expressed as a percentage of the wound area at the time of delamination, per lesion.
Timepoint [2] 314096 0
At 3, 6, and 12 months after BTM application
Secondary outcome [3] 314097 0
Scar quality after healing measured by Vancouver Scar Scale, per lesion.
Timepoint [3] 314097 0
At 3, 6, and 12 months after BTM application
Secondary outcome [4] 314098 0
Incidence of infection at BTM treated lesions assessed by: i. Clinical criteria (one or more of the following): erythema, pain, purulence, swelling AND ii. Microbiological criteria: organisms confirmed via swab or tissue microscopy or culture.
Timepoint [4] 314098 0
Day 0 (BTM placement) AND 3, 6 and 12 months after BTM placement.
Secondary outcome [5] 314099 0
Incidence of Adverse events (AEs) other than infection, such as fluid collection under the BTM, integration failure of BTM, partial or full failure of the skin graft, or spontaneous separation of the seal membrane. Any such events observed during clinical assessment will be recorded,
Timepoint [5] 314099 0
From recruitment until the 12-month follow-up.
Secondary outcome [6] 314100 0
Time to skin grafting after implantation of BTM, per lesion
Timepoint [6] 314100 0
At time of skin grafting using SSG.

Eligibility
Key inclusion criteria
1. Patients suffering thermal burn injuries (deep-dermal/full thickness) involving 10-70% total body surface area (TBSA) requiring excision and split skin grafting.
2. Patients aged 18 - 70 years, inclusive.
3. Patient agrees to all required follow-up procedures and visits.
4. Patient or legal representative provides written, informed consent.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with burn(s) solely confined to the following “excluded” anatomical sites: hands, face, neck and soles of the feet.
2. Females who are pregnant or breast-feeding, or who may get pregnant during the period of the study or who are of childbearing potential and unwilling to use a reliable method of contraception
3. Patient with history of allergy or previous reaction to polyurethane dressing materials.
4. Patient with a concomitant medical condition with a life expectancy of less than 12 months (e.g. advanced malignancy).
5. Patient who has a pre-existing infection which may interfere with the take of the matrix.
6. Patient who has expressed a refusal to participate.
7. 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)
Allocation is not concealed.
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
Based on a reports in the literature of similar treatments and a postulated standard deviation (SD) for % take rate of SSG of 16.0%, then 44 wounds will provide 90% power to test the null hypothesis that mean % take rate of SSG was less than or equal
to 77% against the alternative hypothesis of mean % take rate of
SSG equal to 85%. It is anticipated that 25 - 30 enrolled patients will be required to
achieve BTM application for 44 wounds. Analysis will be conducted on an intent-to-treat (ITT) basis.

Statistical analyses will be conducted using SAS System (Registered Trademark), Version 9.4 or higher and will follow a statistical analysis plan established before database lock.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Anticipated
Actual
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3696 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9528 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 6813 0
France
State/province [1] 6813 0
Toulon

Funding & Sponsors
Funding source category [1] 291099 0
Commercial sector/Industry
Name [1] 291099 0
PolyNovo Biomaterials Pty Ltd
Address [1] 291099 0
Unit 2/320 Lorimer Street
Port Melbourne, VIC 3207
Country [1] 291099 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PolyNovo Biomaterials Pty Ltd
Address
Unit 2/320 Lorimer Street
Port Melbourne, VIC 3207
Country
Australia
Secondary sponsor category [1] 289775 0
Other Collaborative groups
Name [1] 289775 0
MedPass International SAS
Address [1] 289775 0
95 bis Boulevard Pereire - 75017 Paris
Country [1] 289775 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292679 0
Comite de Protection des Personnes Sud Mediterranee IV
Ethics committee address [1] 292679 0
Hopital St. Eloi - 34295 MONTPELLIER CEDEX 5
Ethics committee country [1] 292679 0
France
Date submitted for ethics approval [1] 292679 0
22/08/2014
Approval date [1] 292679 0
10/03/2015
Ethics approval number [1] 292679 0
2014-A01234-43
Ethics committee name [2] 293693 0
The Alfred Hospital Ethics Committee
Ethics committee address [2] 293693 0
Ground Floor, Linay Pavilion
The Alfred
55 Commercial Road, Melbourne
VIC 3004
Ethics committee country [2] 293693 0
Australia
Date submitted for ethics approval [2] 293693 0
23/04/2015
Approval date [2] 293693 0
11/06/2015
Ethics approval number [2] 293693 0

Summary
Brief summary
The primary purpose of the study is to evaluate the safety and performance of a novel, biodegradable dermal matrix for the treatment of patients with deep burns (deep-dermal/full-thickness injuries) involving 10-70% total body surface area (TBSA) requiring burn excision and significant skin grafting.

Current standard of care for deep partial or full-thickness burns includes early excision of necrotic tissue and prompt coverage. This attenuates the postburn hypermetabolic response, decreases fluid loss, and ultimately improves survival.

A full thickness autograft (skin transplant) is used to cover the debrided wound. However, if the extent of the burns is very severe, then this approach becomes impracticable, there is not enough healthy skin left to harvest and the patient is already too unwell to cope with another large wound.

For moderate to large burn injuries in subjects, grafting at a second operation allows significant physiological recovery of the subject prior to graft harvest and application. Reducing the early surgical ‘insult’ to major burn injury sufferers is important in assisting patient survival and reduces the risk of loss of resources (such as harvested applied skin grafts and skin graft donor sites) secondary to physiological insufficiency or deterioration.

The Biodegradable Temporising Matrix (BTM), manufactured and assembled by PolyNovo Biomaterials Pty Ltd has been designed specifically for use in extensive full thickness burn injuries, but its structure and properties make it suitable for other full thickness wounds where dermal reconstruction is necessary or desirable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56550 0
Dr Heather Cleland
Address 56550 0
The Alfred Hospital
55 Commercial Road
Melbourne, VIC 3004
Country 56550 0
Australia
Phone 56550 0
+61 3 9076 3626
Fax 56550 0
Email 56550 0
H.Cleland@alfred.org.au
Contact person for public queries
Name 56551 0
Mr Paul Brennan
Address 56551 0
PolyNovo Ltd
Unit 2/320 Lorimer St, Port Melbourne
VIC 3207
Country 56551 0
Australia
Phone 56551 0
+61 3 8681 4055
Fax 56551 0
+61 3 8681 4099
Email 56551 0
paul.b@polynovo.com
Contact person for scientific queries
Name 56552 0
Dr Timothy Barker
Address 56552 0
PolyNovo Biomaterials Pty Ltd
Unit 2/320 Lorimer St, Port Melbourne
VIC 3207
Country 56552 0
Australia
Phone 56552 0
+61 3 8681 4050
Fax 56552 0
+61 3 8681 4099
Email 56552 0
tim.b@polynovo.com