Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000405516
Ethics application status
Approved
Date submitted
17/04/2015
Date registered
30/04/2015
Date last updated
23/06/2021
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
23/04/2019
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 evaluation of the synthetic NovoSorb TM Biodegradable Temporising Matrix (BTM) for dermal repair after deep burn injury
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.
Secondary outcome [7] 336877 0
Percentage of SSG 'take' over BTM 7-10 days after grafting as a proportion of the total amount of skin graft applied,

SSG ‘take’ is assessed by determining the amount of SSG that survived by visual means and clinical judgement.
Timepoint [7] 336877 0
7-10 days after skin grafting

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
Sex
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
If the level of significance is set to 0.05 with a 2-sided test, a postulated standard deviation for average % take rate of SSG of 12.5% then 28 patients will provide 90% power to test the null hypothesis that average % take rate of SSG was less than or equal to 77% against the alternative hypothesis that average % take rate of SSG was equal to 85%. The 95% confidence interval (CI) for average % take rate of SSG will be approximately ±4.6%, which provides a narrow CI for the estimation of average % take rate of SSG. Analysis will be conducted on an intent-to-treat (ITT) basis.

The sample size will be increased to 30 to allow for some early withdrawals.

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
Completed
Date of first participant enrolment
Anticipated
5/08/2015
Actual
3/09/2015
Date of last participant enrolment
Anticipated
31/12/2017
Actual
17/05/2018
Date of last data collection
Anticipated
28/06/2019
Actual
10/05/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 3696 0
The Alfred - Prahran
Recruitment hospital [2] 8532 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 8533 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 8534 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 9528 0
3004 - Melbourne
Recruitment postcode(s) [2] 16626 0
4029 - Herston
Recruitment postcode(s) [3] 16627 0
2139 - Concord
Recruitment postcode(s) [4] 16628 0
2065 - St Leonards
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
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
Emergo Clinical B.V.
Address [1] 289775 0
Prinsessegracht 20, 2514 AP The Hague
Country [1] 289775 0
Netherlands

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
HREC/16/Alfred/157

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
[email protected]
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
[email protected]
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
[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
Summary results will be sufficient to document study outcomes.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 368373-(Uploaded-14-12-2020-10-51-33)-Basic results summary.pdf
Plain language summaryNo The current treatment for patients with burns incl... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWound healing and dermal regeneration in severe burn patients treated with NovoSorb Biodegradable Temporising Matrix: A prospective clinical study.2022https://dx.doi.org/10.1016/j.burns.2021.07.014
N.B. These documents automatically identified may not have been verified by the study sponsor.