ANZCTR - Registration

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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

2/11/2021

Date data sharing statement initially provided

16/08/2019

Date results provided

2/11/2021

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]

None

Universal Trial Number (UTN)

U1111-1234-5259

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burns

Paediatric skin grafts

Donor site wound

Condition category

Condition code

Surgery

Surgical techniques

Injuries and Accidents

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]

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]

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]

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]

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]

Three months from opening of survey

Secondary outcome [2]

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]

Three months from opening of survey

Secondary outcome [3]

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]

Three months from opening of survey

Secondary outcome [4]

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]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

1/09/2019

Actual

20/11/2019

Date of last participant enrolment

Anticipated

1/12/2019

Actual

14/12/2019

Date of last data collection

Anticipated

1/12/2019

Actual

14/12/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Human Research Ethics Committee

Ethics committee address [1]

Level 7
Centre for Children's Health Research
Children's Health Queensland
62 Graham Street
South Brisbane
Qld 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/05/2019

Approval date [1]

06/06/2019

Ethics approval number [1]

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

Dr Craig McBride

Address

Level 7D Surgical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 3068 1111

Fax

Craig.McBride@health.qld.gov.au

Contact person for public queries

Name

Craig McBride

Address

Level 7D Surgical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 3068 1111

Fax

Craig.McBride@health.qld.gov.au

Contact person for scientific queries

Name

Craig McBride

Address

Level 7D Surgical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 3068 1111

Fax

Craig.McBride@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2236	Study protocol					377695-(Uploaded-31-05-2019-21-30-31)-Study-related document.pdf
13900	Other	Blank copy of SurveyMonkey form emailed to participants			Survey form	377695-(Uploaded-01-01-2020-17-12-09)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		McBride CA, Patel B, Kimble RM, Stockton KA Surgeo... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Surgeon's practices and beliefs in Australia and New Zealand regarding the donor site wound for paediatric skin grafts.	2021	https://dx.doi.org/10.1111/jpc.15117

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically