Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000753954
Ethics application status
Approved
Date submitted
29/06/2011
Date registered
18/07/2011
Date last updated
6/12/2018
Date data sharing statement initially provided
6/12/2018
Date results information initially provided
6/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Repairing a deep donor site using a new, dissolvable, plastic scaffold.
Scientific title
An evaluation of function and appearance following reconstruction of a free-flap donor site after biodegradable polymer implant incorporation and secondary split skin grafting.
Secondary ID [1] 262530 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post harvest Free flap donor site appearance and function 268198 0
Condition category
Condition code
Skin 268326 268326 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following free-flap harvest (either anterolateral thigh flap or radial forearm flap), a biodegradable polyurethane dermal matrix sealed with a non-biodegradable polyurethane film will be implanted into the donor site. When integrated, the film is removed and a thin split skin graft applied to the integrated neo-dermis.
Intervention code [1] 266875 0
Treatment: Devices
Comparator / control treatment
Comparison will be made against data collected in 2010 and 2011 in porcine wounds of similar depth where a variety of treatments were employed. These included healing by secondary intention, implantation of unsealed polymer matrices, implantation of sealed polymer matrices, matrices with immediate split skin graft application, matrices with delayed split-skin graft application, matrices with sealing membranes of different thicknesses.
Control group
Historical

Outcomes
Primary outcome [1] 269096 0
Appearance of the donor site compared to historical data. Assessment will be by clinical appearance (incorporation of the foam is visible and progressive to day 7 then consolidates), ease of delamination of the sealing membrane in historical comparison to Integra dermal regeneration template, Visitrak wound measurement to assess degree of contraction.
Timepoint [1] 269096 0
Weekly to 6 weeks, then monthly to 12 months
Secondary outcome [1] 276922 0
Function of the donor site compared to historical data. This will be assessed by clinical means (pinching, shearing mobility, visibilty or otherwise of deeper structures (eg tendons in free radial forearm flap donor sites).
Timepoint [1] 276922 0
Weekly to 6 weeks, then monthly to 12 months

Eligibility
Key inclusion criteria
Ability to provide informed consent; requirement for free-flap surgery involving either anterolateral thigh flap or radial forearm flapfree
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, severe debility precluding second anaesthetic; inability to provide informed 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)
Full discussion with patient deemed to need one of the two free flaps mentioned previously; acquisition of informed consent if willing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
Actual
29/08/2012
Date of last participant enrolment
Anticipated
Actual
28/07/2013
Date of last data collection
Anticipated
Actual
29/02/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 267347 0
Commercial sector/Industry
Name [1] 267347 0
NovoSkin Pty Ltd
Country [1] 267347 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
NovoSkin Pty Ltd
Address
38 Tom Packer Drive, Athelstone 5076, South Australia
Country
Australia
Secondary sponsor category [1] 266413 0
Hospital
Name [1] 266413 0
Royal Adelaide Hospital
Address [1] 266413 0
Department of Plastic and Reconstructive Surgery, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country [1] 266413 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269324 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 269324 0
Level 3, Hanson Institute (IMVS Building)
Royal Adelaide Hospital, North Terrace, Adelade 5000, South Australia
Ethics committee country [1] 269324 0
Australia
Date submitted for ethics approval [1] 269324 0
16/06/2011
Approval date [1] 269324 0
23/06/2011
Ethics approval number [1] 269324 0
110613

Summary
Brief summary
Single group study of efficacy in improving free flap donor sites by first integrating a biodegradable polyurethane dermal matrix before skin grafting.
Trial website
Trial related presentations / publications
- Li A, Dearman BL, Crompton KE, Moore TG, Greenwood JE. Evaluation of a novel biodegradable polymer for the generation of a dermal matrix. Journal of Burn Care and Research 2009;30(4):717-728.
- Greenwood JE, Li A, Dearman BL, Moore TG. Evaluation of NovoSorb novel biodegradable polymer for the generation of a dermal matrix. Part 1: In-vitro studies. Wound Practice and Research 2010;18(1):14-22.
- Greenwood JE, Li A, Dearman BL, Moore TG. Evaluation of NovoSorb novel biodegradable polymer for the generation of a dermal matrix. Part 2: In-vivo studies. Wound Practice and Research 2010;18(1):24-34.
- Greenwood JE. Biodegradable polyurethane as a dermal matrix. Journal of Burn Care and Research 2011; 32(2) (supplement):S58.
- Greenwood JE, Dearman BL. Split-skin graft application over an integrating, biodegradable temporising polymer matrix: Immediate and delayed. Journal of Burn Care and Research (accepted).
- Greenwood JE, Dearman BL. Comparison of a sealed, NovoSorb biodegradable temporising matrix (BTM) against Integra: a prospective, porcine study. Journal of Burn Care and Research (accepted).
Public notes

Contacts
Principal investigator
Name 32812 0
A/Prof John E Greenwood
Address 32812 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 32812 0
Australia
Phone 32812 0
+61 8 8222 2233
Fax 32812 0
+61 8 8222 5676
Email 32812 0
[email protected]
Contact person for public queries
Name 16059 0
A/Prof John E Greenwood
Address 16059 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 16059 0
Australia
Phone 16059 0
+61 8 8222 2233
Fax 16059 0
+61 8 8222 5676
Email 16059 0
[email protected]
Contact person for scientific queries
Name 6987 0
A/Prof John E Greenwood
Address 6987 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 6987 0
Australia
Phone 6987 0
+61 8 8222 2233
Fax 6987 0
+61 8 8222 5676
Email 6987 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes MJD Wagstaff, BJ Schmitt, P Coghlan, JP Finkemeyer... [More Details] 343134-(Uploaded-06-12-2018-13-01-40)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.