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Trial registered on ANZCTR


Registration number
ACTRN12619001148167
Ethics application status
Approved
Date submitted
31/05/2019
Date registered
16/08/2019
Date last updated
16/08/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Paediatric Donor Site Wounds in Australasia
Scientific title
Survey of beliefs and practices regarding the donor site wound in paediatric split-thickness skin grafts
Secondary ID [1] 298385 0
None
Universal Trial Number (UTN)
U1111-1234-5259
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 313068 0
Paediatric skin grafts 313069 0
Donor site wound 313070 0
Condition category
Condition code
Surgery 311557 311557 0 0
Surgical techniques
Injuries and Accidents 311558 311558 0 0
Burns

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Survey of Australasian surgeons performing split-thickness skin grafts in children with burn injuries - to determine their practices and beliefs.
Survey is study-specific.
Single survey only for each respondent.
Testing has demonstrated survey can be completed in 5-7 minutes.
Intervention code [1] 314628 0
Not applicable
Comparator / control treatment
Some survey questions are replicated from a previously published survey (Lyall PW, Sinclair SW. Australasian survey of split skin donor site dressings. Australian and New Zealand Journal of Surgery 2000;70(2):114–6.).
Other questions are specific to this survey and therefore there is no control or comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320265 0
Benchmark current practice regarding treatment of the donor site wound in children. This will be done via a study specific survey - each site will specify their standard treatments of the donor site wound. This may be surgeon specific, or it may be site specific.
Timepoint [1] 320265 0
Primary timepoint is time when survey is completed.
Data collection will close 3/12 from surveys first being sent out to potential respondents.
Secondary outcome [1] 371037 0
1. To determine whether there are differences in practice, determined by geography (Australia vs New Zealand, state differences)

Assessed via the study specific survey
Timepoint [1] 371037 0
Three months from opening of survey
Secondary outcome [2] 371038 0
To determine if there have been appreciable changes since a similar survey was done in Australia

Assessed via the study specific survey, and comparing those results to Lyall's previously published data.
Timepoint [2] 371038 0
Three months from opening of survey
Secondary outcome [3] 373635 0
To determine whether there are differences in practice, determined by experience (years since Fellowship, practices of peers, number treated annually)

Assessed via the study specific survey.
Timepoint [3] 373635 0
Three months from opening of survey
Secondary outcome [4] 373636 0
To determine whether there are differences in practice, determined by type of practice (paediatric only vs mixed adult and children)

Assessed via the study specific survey
Timepoint [4] 373636 0
Three months from opening of survey

Eligibility
Key inclusion criteria
1. Consultant surgeon
2. Working in a burns unit
3. Treating children with burns
4. Creating donor site wounds for STSG
5. Working in Australia or New Zealand
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil, covered above in inclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
A detailed data analysis plan will be prepared prior to analysis. Data will be audited, cleaned and locked prior to final analysis. Names will be deleted and data analysed in aggregate only.

Subgroup analyses, as per the secondary outcomes of interest, will include the following co-variates:
• Geography (Australia vs New Zealand, state differences)
• Experience (years since Fellowship, practices of peers, number treated annually)
• Type of practice (paediatric only vs mixed adult and children)

It is unlikely data will be normally distributed, therefore non-parametric analyses will be used. Tests will be two-tailed, and a p value of 0.05 will be deemed significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 13883 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 26655 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 21543 0
New Zealand
State/province [1] 21543 0

Funding & Sponsors
Funding source category [1] 302921 0
Self funded/Unfunded
Name [1] 302921 0
Address [1] 302921 0
Country [1] 302921 0
Primary sponsor type
Hospital
Name
Pegg Leditschke Children's Burns Centre, Queensland Children's Hospital
Address
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country
Australia
Secondary sponsor category [1] 302885 0
None
Name [1] 302885 0
Address [1] 302885 0
Country [1] 302885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303490 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 303490 0
Level 7
Centre for Children's Health Research
Children's Health Queensland
62 Graham Street
South Brisbane
Qld 4101
Ethics committee country [1] 303490 0
Australia
Date submitted for ethics approval [1] 303490 0
30/05/2019
Approval date [1] 303490 0
06/06/2019
Ethics approval number [1] 303490 0
LNR/18/QCHQ/55654

Summary
Brief summary
The donor site wound (DSW) in paediatric split-thickness skin grafts (STSG) is an often-overlooked area of wound management; with most attention typically on the STSG itself rather than the iatrogenic DSW.

This survey seeks to determine the opinions and practices of burns surgeons in Australia and New Zealand, with respect to their treatment of the donor site wound in children as a consequence of skin grafting.

To some degree this has been done before, by Australasian Plastic Surgeon Patrick Lyall. [1] A similar survey, though with different questions, was carried out in the United Kingdom (UK) in 2012. [2]

Properties of an ‘ideal’ DSW dressing have been investigated at a world level by survey of practising clinicians. [3] While this survey had a small number of respondents only, most agreed an ‘ideal’ DSW dressing did not currently exist. Desirable qualities included lack of adhesion to the wound bed, pain-free dressing changes, absorbency, and ease of removal.

This study forms part of the PhD thesis of the primary investigator. It is part of a suite of publications in the field of paediatric donor site wounds. [4-7] The study is an electronic survey of Australasian Burns Surgeons practising in centres treating children with burns.

[1] Lyall PW, Sinclair SW. Australasian survey of split skin graft donor site dressings. Aust N Z J Surg 2000;70:114–6.
[2] Geary PM, Tiernan E. Management of Split Skin Graft Donor Sites–Results of a National Survey. Clinics in Plastic Surgery 2012;39:77–84. doi:10.1016/j.cps.2011.09.012.
[3] Lars PKLP, Giretzlehner M, Trop M, Parvizi D, Spendel S, Schintler M, et al. The properties of the “ideal” donor site dressing: results of a worldwide online survey. Ann Burns Fire Disasters 2013;26:136–41.
[4] McBride CA, Patel B, Stockton KA, Kapoor V, Kimble RM. Alginate dressings for donor sites of split-thickness skin grafts. Cochrane Database of Systematic Reviews 2018;49:129–18. doi:10.1002/14651858.CD013048.
[5] McBride CA, Kimble RM, Stockton KA. Prospective randomised controlled trial of Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts. Burns Trauma 2018;6:1028. doi:10.1186/s41038-018-0135-y.
[6] McBride CA, Kimble RM, Stockton K. Three donor site dressings in paediatric split-thickness skin grafts: study protocol for a randomised controlled trial. Trials 2015;16:557.
[7] McBride CA, Kempf M, Kimble RM, Stockton K. Variability in split-thickness skin graft dept
Trial website
Nil
Trial related presentations / publications
Public notes
[1] Lyall PW, Sinclair SW. Australasian survey of split skin graft donor site dressings. Aust N Z J Surg 2000;70:114–6.
[2] Geary PM, Tiernan E. Management of Split Skin Graft Donor Sites–Results of a National Survey. Clinics in Plastic Surgery 2012;39:77–84. doi:10.1016/j.cps.2011.09.012.
[3] Lars PKLP, Giretzlehner M, Trop M, Parvizi D, Spendel S, Schintler M, et al. The properties of the “ideal” donor site dressing: results of a worldwide online survey. Ann Burns Fire Disasters 2013;26:136–41.
[4] McBride CA, Patel B, Stockton KA, Kapoor V, Kimble RM. Alginate dressings for donor sites of split-thickness skin grafts. Cochrane Database of Systematic Reviews 2018;49:129–18. doi:10.1002/14651858.CD013048.
[5] McBride CA, Kimble RM, Stockton KA. Prospective randomised controlled trial of Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts. Burns Trauma 2018;6:1028. doi:10.1186/s41038-018-0135-y.
[6] McBride CA, Kimble RM, Stockton K. Three donor site dressings in paediatric split-thickness skin grafts: study protocol for a randomised controlled trial. Trials 2015;16:557.
[7] McBride CA, Kempf M, Kimble RM, Stockton K. Variability in split-thickness skin graft depth when using an air-powered dermatome: A paediatric cohort study. Burns 2017;43:1552–60. doi:10.1016/j.burns.2017.02.010.

Contacts
Principal investigator
Name 93838 0
Dr Craig McBride
Address 93838 0
Level 7D Surgical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 93838 0
Australia
Phone 93838 0
+61 7 3068 1111
Fax 93838 0
Email 93838 0
Craig.McBride@health.qld.gov.au
Contact person for public queries
Name 93839 0
Dr Craig McBride
Address 93839 0
Level 7D Surgical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 93839 0
Australia
Phone 93839 0
+61 7 3068 1111
Fax 93839 0
Email 93839 0
Craig.McBride@health.qld.gov.au
Contact person for scientific queries
Name 93840 0
Dr Craig McBride
Address 93840 0
Level 7D Surgical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 93840 0
Australia
Phone 93840 0
+61 7 3068 1111
Fax 93840 0
Email 93840 0
Craig.McBride@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregated responses will be available to other researchers, upon reasonable request and following review of such a request by the original ethics committee. Identifying data (names, geographic fields with fewer than 5 respondents) will be censored.
Individual responses will be made available to responders upon request, to facilitate individual comparisons with the total data set.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2236 0
Study protocol
Citation [1] 2236 0
Link [1] 2236 0
Email [1] 2236 0
Other [1] 2236 0
Summary results
No Results