Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001162101
Ethics application status
Approved
Date submitted
9/08/2019
Date registered
20/08/2019
Date last updated
18/02/2022
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
18/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to assess the long-term safety and performance of patients previously treated with NovoSorb® Biodegradable Temporising Matrix (BTM) for the repair of skin injuries.
Scientific title
Long-term safety and effectiveness evaluation of participants treated with NovoSorb® Biodegradable Temporising Matrix (BTM) for dermal repair: An observational cohort study
Secondary ID [1] 299020 0
None
Universal Trial Number (UTN)
U1111-1237-8303
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermal injury 313867 0
Condition category
Condition code
Skin 312276 312276 0 0
Other skin conditions
Surgery 312277 312277 0 0
Other surgery
Injuries and Accidents 312278 312278 0 0
Burns
Injuries and Accidents 312279 312279 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This post-marketing clinical follow-up study aims to evaluate the long-term (>= 18 months) safety and effectiveness of BTM in patients previously treated for dermal repair involving >= 5% total body surface area (TBSA) of device coverage and more than one device implanted. A single study visit, estimated to take 60 minutes. will be conducted including documenting current health status, physical examination, assessment of areas where BTM was applied, and completion of questionnaires by the clinician and patient. Data to be collected will also include details of the surgical application of BTM and post-operative treatment period from existing medical records.
Intervention code [1] 315167 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320917 0
Device safety as evaluated by the incidence of device-related adverse events/device effects, and device deficiencies as a composite primary outcome.
Timepoint [1] 320917 0
Single follow-up assessment at least 18 months after BTM application
Primary outcome [2] 320918 0
Device performance as evaluated by per lesion assessment of scar quality after healing, measured by the Patient and Observer Scar Assessment Scale (POSAS).
Timepoint [2] 320918 0
Single follow-up assessment at least 18 months after BTM application.
Secondary outcome [1] 373326 0
Nil
Timepoint [1] 373326 0
Nil

Eligibility
Key inclusion criteria
1. Patient must have had BTM device(s) implanted for a period of at least 18 months
2. Patient must have had BTM device coverage of >= 5% TBSA
3. Patient agrees and is able to take part in the follow-up visit and assessments
4. Patient provides written, informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient was last treated with BTM device(s) < 18 months ago
2. Patient was treated with BTM device(s) with < 5% TBSA coverage
3. Patient has expressed a refusal to participate

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
No sample size calculation was performed as this is an observational study of a pool of patients previously treated with BTM for dermal repair at the study sites.

Data analysis will include using standard numeric descriptive statistics including the n (number of non-missing observations), mean, median, minimum value, and maximum value.

Categorical variables will be summarised using classical frequency statistics: number of non-missing observations and percentages by categories.

Safety analysis in terms of device-related adverse events/device effects will be summarised by number, percentage and frequency on a lesion basis and on a subject basis.

Scar quality as measured by POSAS will be reported at the time of assessment. The total scores for Observer and Patient for POSAS will each be reported as mean, SD, 95% CI, minimum, median, and maximum.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2021
Actual
26/02/2021
Date of last participant enrolment
Anticipated
Actual
21/05/2021
Date of last data collection
Anticipated
Actual
21/05/2021
Sample size
Target
40
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 14363 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 14364 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 27366 0
3004 - Melbourne
Recruitment postcode(s) [2] 27365 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303434 0
Commercial sector/Industry
Name [1] 303434 0
PolyNovo Biomaterials Pty Ltd
Country [1] 303434 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] 303490 0
None
Name [1] 303490 0
Address [1] 303490 0
Country [1] 303490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303970 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303970 0
1 Hospital Boulevard, Southport
QLD 4215
Ethics committee country [1] 303970 0
Australia
Date submitted for ethics approval [1] 303970 0
14/08/2019
Approval date [1] 303970 0
25/09/2019
Ethics approval number [1] 303970 0
HREC/2019/QGC/57141

Summary
Brief summary
PolyNovo Biomaterials Pty Ltd has developed a new medical device, NovoSorb® Biodegradable Temporising Matrix (BTM), BTM is a skin substitute used to treat patients who need their wounds to be covered after an injury such as a deep burn, an accident where the skin has been damaged, or a severe skin infection.

This study will assess the long-term safety and performance in patients where BTM was applied to at least 5% of their body at least 18 months ago.

Patients will be asked to return to their hospital where a surgeon will examine them to assess their current health. Areas of the body where BTM was applied will also be examined by the surgeon. Patients will also assess the areas treated with BTM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95406 0
Dr Lindsay Damkat-Thomas
Address 95406 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 95406 0
Australia
Phone 95406 0
+61 8 7074 2404
Fax 95406 0
Email 95406 0
lindsay.damkat-thomas@sa.gov.au
Contact person for public queries
Name 95407 0
Mr Paul Brennan
Address 95407 0
PolyNovo Biomaterials Pty Ltd
2/320 Lorimer Street
Port Melbourne VIC 3207
Country 95407 0
Australia
Phone 95407 0
+61386814055
Fax 95407 0
Email 95407 0
paul.b@polynovo.com
Contact person for scientific queries
Name 95408 0
Mrs Kate Bilney
Address 95408 0
PolyNovo Biomaterials Pty Ltd
2/320 Lorimer Street
Port Melbourne VIC 3207
Country 95408 0
Australia
Phone 95408 0
+61 448 075 384
Fax 95408 0
Email 95408 0
kate.b@polynovo.com

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 378087-(Uploaded-15-12-2021-15-56-41)-Basic results summary.docx
Plain language summaryNo Various dermal substitutes exist and assist the ma... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term scarring outcomes and safety of patients treated with NovoSorb Biodegradable Temporizing Matrix (BTM): An observational cohort study.2023https://dx.doi.org/10.1016/j.jpra.2023.05.003
N.B. These documents automatically identified may not have been verified by the study sponsor.