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Trial registered on ANZCTR


Registration number
ACTRN12614000380695
Ethics application status
Approved
Date submitted
28/03/2014
Date registered
8/04/2014
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Date results information initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of donor site dressings in paediatric split skin grafts
Scientific title
Randomised controlled trial comparing three different donor site dressings (Sorbact, Cuticerin, Algisite) in paediatric patients undergoing split skin grafting for burn injury in terms of time to re-epithelialisation, pain and itch while dressing on, ease of application, care, and removal, cosmetic appearance of donor site and cost
Secondary ID [1] 284350 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Burns 291503 0
Condition category
Condition code
Surgery 291874 291874 0 0
Surgical techniques
Injuries and Accidents 291912 291912 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three different donor site dressings
- Cuticerin. A smooth acetate gauze dressing impregnated with a water repellant petrolatum ointment
- Sorbact. A hydrogel applied to a mesh dressing designed to absorb bacteria onto itself from the wound bed by hydrophobic reaction
- Algisite. This is a calcium alginate dressing, the most common dressing used on donor sites in this region

All dressings come in premade peel packs, and can be simply applied in theatre directly to the wound bed. This will then be covered with an absorbent second layer dressing (allevyn) and tape (hypafix). Dressings will be removed at seven days to assess the wound, then reapplied if necessary every seven days until full re-epithelialisation
Intervention code [1] 289075 0
Treatment: Other
Comparator / control treatment
Active control - with all dressings being compared against each other. All three dressings currently in use in the department.
Control group
Active

Outcomes
Primary outcome [1] 291792 0
Time to re-epithelialisation assessed in two ways.
- Clinical judgement by surgeon treating the patient
- Blinded second assessment from digital photographs
Timepoint [1] 291792 0
Expected 7-14 days
Primary outcome [2] 291793 0
Pain while dressing in situ. Pain at dressing change. Assessed via multiple methods - FACES-R/NRS/FLACC - depending on age of patient.
Timepoint [2] 291793 0
Expected 7-14 days. Once daily while dressing is on (parent, self report). During clinic visit weekly for nurse report
Primary outcome [3] 291794 0
Cosmetic appearance of donor site by POSAS (Pt and Observor Scar Assessment Scale)
3D camera (for depth/height, and colour)
Ultrasound (for thickness of scar tissue)
Timepoint [3] 291794 0
3 and 6 months
Secondary outcome [1] 307558 0
Dressing costs. Assessment will include
- Nursing time for dressing changes
- Cost of dressings
- Medication costs associated with dressings (analgesia)
all as per current clinical standards
Timepoint [1] 307558 0
Time for dressing change will be measured at each dressing change.
Medication and dressing costs will be totalled once donor site wound has re-epithelialised
Secondary outcome [2] 307559 0
Ease of dressing application. Measures used will include
- flexibility and conformity using a NRS 0-4
- Patient/parent perception – comfort, ease of movement and ease of dressing removal using NRS
- nursing assessment ease of application, care, and removal
Timepoint [2] 307559 0
Until re-epithelialisation. Expected 7-14 days as above. May extend to 28 days in rare cases
Secondary outcome [3] 307690 0
Number of dressing changes
Timepoint [3] 307690 0
Expected dressing change each week at clinical review. If additional dressings are needed (due to strikethrough from wound, or longer time to re-epithelialise) these will be assessed. Expected longest time to remain under dressings is 4 weeks.
Secondary outcome [4] 308595 0
Itch
Timepoint [4] 308595 0
Itch with dressings in situ, and at three and six month checks. Itch will be assessed using the Itch man scale < 6years of age by parent report, >6years by self report
This will be assessed four hours after operation (to allow assessment prior to discharge), also at 24 hours by phone call, and at each dressing change as for pain scores.

Eligibility
Key inclusion criteria
Patients of the Stuart Pegg Paediatric Burns Centre (SPPBC) undergoing split skin grafting for burns
Minimum age
0 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged >15 years of age
Non-English speaking
Cognitive impairment
Current involvement with Department Communities (Child Safety)

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)
Sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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
Primary outcomes of pain and re-epithelialisation with a 5% significance level and a power of 80%, 28 patients per group required. Allowing for 10% drop-out gives 93 patients in total.
Data analysis via SPSS (ver20). ANOVA to assess differences between groups. Non parametric tests where appropriate. Generalised linear mixed model will be utilised to analyse differences in pain and itch over time. Intention to treat analysis with significance of 0.05. Statistician will be contracted to be involved in data analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2014
Actual
17/04/2014
Date of last participant enrolment
Anticipated
Actual
15/07/2016
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
93
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2269 0
Royal Children's Hospital - Herston
Recruitment hospital [2] 13925 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 7938 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 26695 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 288992 0
Commercial sector/Industry
Name [1] 288992 0
Abigo Ab
Country [1] 288992 0
Sweden
Primary sponsor type
Hospital
Name
Stuart Pegg Paediatric Burns Centre
Address
Royal Children's Hospital
Herston Road
Herston
Qld 4029
Country
Australia
Secondary sponsor category [1] 287671 0
None
Name [1] 287671 0
Address [1] 287671 0
Country [1] 287671 0
Other collaborator category [1] 277902 0
University
Name [1] 277902 0
Queensland Children's Medical Research Institute,
University of Queensland
Address [1] 277902 0
Level Four Foundation Building
Royal Children's Hospital
Herston Road
Herston
Qld 4029
Country [1] 277902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290800 0
Royal Children's Hospital HREC
Ethics committee address [1] 290800 0
Level 3 Foundation Building
Royal Children's Hospital
Herston Road
Herston
Qld 4029
Ethics committee country [1] 290800 0
Australia
Date submitted for ethics approval [1] 290800 0
Approval date [1] 290800 0
20/03/2014
Ethics approval number [1] 290800 0
HREC/14/QRCH/36

Summary
Brief summary
Paediatric split skin grafts leave a donor site, requiring a dressing. The optimum dressing for this site is the subject
of much discussion and debate amongst burns clinicians. In our unit there are currently three dressings in regular
use. We therefore have equipoise to undertake a randomised controlled trial in an effort to determine which is the
best of the three. Outcome measures we will be examining relate to both patients and staff. These outcomes
include
pain
and itch while the dressing is on
ease
of application, care, and removal
time
to reepithelialisation
cost
cosmetic
appearance of the donor site
There are a number of such trials in the literature. None of them have directly compared our three dressings
(algisite, cuticerin, sorbact). Few of the trials in the literature have looked at children, so the answer is not already in
the literature.
By using real world controls we hope to find the optimum dressing in our environment. This will become our new
preferred dressing, and will naturally then become the new control against which we will measure the performance
of newer products that will inevitably come onto the market in subsequent years.
Patients will be randomised to one or more of the three arms of the study, without them or the assessing staff being
aware of the contact dressing. We will then measure outcomes with the above aims in mind; using previously
validated scoring systems examining the responses of parents, patients and staff members. We will use both
qualitative and quantitative assessment methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47306 0
Dr Craig McBride
Address 47306 0
Royal Children's Hospital
Herston Road
Herston 4029
Qld
Country 47306 0
Australia
Phone 47306 0
+61 7 3636 8111
Fax 47306 0
Email 47306 0
[email protected]
Contact person for public queries
Name 47307 0
Craig McBride
Address 47307 0
Royal Children's Hospital
Herston Road
Herston 4029
Qld
Country 47307 0
Australia
Phone 47307 0
+61 7 3636 8111
Fax 47307 0
Email 47307 0
[email protected]
Contact person for scientific queries
Name 47308 0
Craig McBride
Address 47308 0
Royal Children's Hospital
Herston Road
Herston 4029
Qld
Country 47308 0
Australia
Phone 47308 0
+61 7 3636 8111
Fax 47308 0
Email 47308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be made available upon reasonable request to the study authors, and following perusal and approval of such a request by the Children's Health Queensland Human Research Ethics Committee
When will data be available (start and end dates)?
25 years from conclusion of study, in accordance with NHMRC guidelines
Available to whom?
Investigators on reasonable request
Available for what types of analyses?
Re-analysis of original data
Meta-analysis
How or where can data be obtained?
Data will be emailed to investigators following ethical review and signoff.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes McBride CA, Kimble RM, Stockton KA. Prospective ra... [More Details] 366062-(Uploaded-31-05-2019-12-27-29)-Journal results publication.pdf

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
438Study results articleYes McBride CA, Kimble RM, Stockton KA. Prospective ra... [More Details] 366062-(Uploaded-31-05-2019-12-27-29)-Journal results publication.pdf
2975Plain language summaryNo This trial was designed to determine which donor s... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThree donor site dressings in pediatric split-thickness skin grafts: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0557-9
EmbaseVariability in split-thickness skin graft depth when using an air-powered dermatome: A paediatric cohort study.2017https://dx.doi.org/10.1016/j.burns.2017.02.010
N.B. These documents automatically identified may not have been verified by the study sponsor.