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Trial registered on ANZCTR


Registration number
ACTRN12620000267954p
Ethics application status
Submitted, not yet approved
Date submitted
2/01/2020
Date registered
28/02/2020
Date last updated
28/02/2020
Date data sharing statement initially provided
28/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of paediatric donor sites of split-thickness skin grafts with Suprathel: a randomised control trial
Scientific title
Management of paediatric donor sites of split-thickness skin grafts with Suprathel: a randomised control trial
Secondary ID [1] 299892 0
Nil
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Donor site wounds from split thickness skin grafts 315313 0
Condition category
Condition code
Surgery 313615 313615 0 0
Other surgery
Skin 314287 314287 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two dressings used on donor site wounds in children will be compared in this randomised control trial: Suprathel (covered with Atruman + melolin + hypafix) and Jelonet (covered with melolin + hypafix).

1. Suprathel
- Composed of a synthetic copolymer of polylactide trimethylene carbonate and e-caprolactone and is considered a temporary artificial skin substitute
- Applied intra-operatively (by surgeon) after skin graft is taken, covered with Atruman + melolin + hypafix. Dressing gradually peels off when skin underneath is healed. Reviewed day 5 by nursing staff/occupational therapist, if not healed protective dressing layer re-applied (Atruman + melolin + hypafix). Re-inspected day 10. This is repeated every 5 days until healed.
- Monitored by nursing + parent sheet that contains: pain/distress score for dressing change

2. Jelonet
- Parrafin based guaze dressing
- Applied intra-operatively by surgeon, covered with melolin +hypafix
- Same principles as above, however, dressing is completely removed at each 5d review (by nursing staff) and re-applied if not healed
Intervention code [1] 316162 0
Treatment: Other
Comparator / control treatment
Suprathel dressing
Control group
Active

Outcomes
Primary outcome [1] 322062 0
1. Ease of dressing change
Nursing staff, parents/caregivers +/- child (depending on age) will be asked to complete a short questionnaire to assess the ease of donor site wound dressing change
This questionnaire has been designed for this study and consists of a 1-10 score
Timepoint [1] 322062 0
Dressing change on day 5 and day 10
Primary outcome [2] 322674 0
The time taken for dressing change
- Dressing changes will be timed by nursing staff
Timepoint [2] 322674 0
Day 5 and 10
Secondary outcome [1] 377178 0
Pain
Timepoint [1] 377178 0
Pain - day one post operatively and pre and post dressing changes
- Using either face, legs, activity, crying and consolability score (FLACC) or revised faces pain scale score or 1-10 pain scale --> depending on age of child
Secondary outcome [2] 379264 0
Time to healing
Timepoint [2] 379264 0
Healed at day 5, day 10 or >10 days
Secondary outcome [3] 379265 0
Itch - day one post op, at first dressing change and at scar review 3 months
Timepoint [3] 379265 0
Mild/moderate/intense
Day 1 post op, at first dressing change and at scar review at 3 months
Secondary outcome [4] 379266 0
Scar at 3, 6 and 9 months
Timepoint [4] 379266 0
POSAS scar score

Eligibility
Key inclusion criteria
All patients aged 16 years and younger requiring a clinically indicated split thickness skin graft at our hospital will be invited to participate. Eligibility will be determined by the child’s primary surgeon or an investigator.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include non-english speaking parents or caregivers; children under the care of the Department of Child Safety and children with a cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used using the ‘Research randomizer’ (version 4.0) software. Patients will be divided up into 12 groups of 4 (6 groups of 4 per dressing). An assigned individual independent from the study will be the steward of randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics, tests of normality, mann-whitney u test to compare.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2020
Actual
Date of last participant enrolment
Anticipated
28/03/2021
Actual
Date of last data collection
Anticipated
28/03/2022
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15569 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 28943 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 304349 0
Hospital
Name [1] 304349 0
The Townsville hospital
Country [1] 304349 0
Australia
Primary sponsor type
Hospital
Name
The Townsville hospital
Address
100 Angus Smith Drive, Douglas, QLD, Australia
Country
Australia
Secondary sponsor category [1] 305136 0
None
Name [1] 305136 0
Address [1] 305136 0
Country [1] 305136 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304800 0
Human Research Ethics COmmittee, Townsville Hospital and Health Service
Ethics committee address [1] 304800 0
Ethics committee country [1] 304800 0
Australia
Date submitted for ethics approval [1] 304800 0
30/01/2019
Approval date [1] 304800 0
Ethics approval number [1] 304800 0

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

Contacts
Principal investigator
Name 98250 0
Dr Helen Buschel
Address 98250 0
The Townsville Hospital, 100 Angus Smith Drive, Douglas, QLD, Australia, 4814
Country 98250 0
Australia
Phone 98250 0
+61744331111
Fax 98250 0
Email 98250 0
[email protected]
Contact person for public queries
Name 98251 0
Helen Buschel
Address 98251 0
The Townsville Hospital, 100 Angus Smith Drive, Douglas, QLD, Australia, 4814
Country 98251 0
Australia
Phone 98251 0
+61744331111
Fax 98251 0
-
Email 98251 0
[email protected]
Contact person for scientific queries
Name 98252 0
Helen Buschel
Address 98252 0
The Townsville Hospital, 100 Angus Smith Drive, Douglas, QLD, Australia, 4814
Country 98252 0
Australia
Phone 98252 0
+61744331111
Fax 98252 0
Email 98252 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.