Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001068651
Ethics application status
Approved
Date submitted
22/09/2014
Date registered
7/10/2014
Date last updated
7/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examination of the effect of Negative Pressure Wound Therapy in Acute Paediatric Burns on Re-epithelialisation, Pain and Injury Progression – A pilot study
Scientific title
Examination of the effect of Negative Pressure Wound Therapy in Acute Paediatric Burns on Re-epithelialisation, Pain and Injury Progression – A pilot study
Secondary ID [1] 285383 0
Nil
Universal Trial Number (UTN)
U1111-1162-0654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric burns 293118 0
Condition category
Condition code
Injuries and Accidents 293388 293388 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative pressure wound therapy (Smith and Nephew (TM) Renasys Go)- applied at time of randomisation to intervention group within 12 hours of burn injury and left insitu for three days until first dressing change. From day three onwards all children (regardless of group) will receive standard dressing which for our centre is Acticoat (TM) and Mepitel (TM) secured with hypafix. Feeding tubes are incorporated into the dressing to allow for regular irrigation by parents at home to keep dressing moist.
Intervention code [1] 290298 0
Treatment: Devices
Comparator / control treatment
Standard dressing at our centre which is Acticoat (TM) and Mepitel (TM) secured with hypafix. Feeding tubes are incorporated into the dressing to allow for regular irrigation by parents at home to keep dressing moist.
Control group
Active

Outcomes
Primary outcome [1] 293220 0
Wound progression - assess difference in laser doppler imaging from day of injury to day 3.
Timepoint [1] 293220 0
Day 3 post injury
Primary outcome [2] 293221 0
Wound re epithelialisation
- Clinical judgement by surgeon treating the patient
- Blinded second assessment from digital photographs
Timepoint [2] 293221 0
Expected day 10-14 following injury
Primary outcome [3] 293222 0
Pain
Timepoint [3] 293222 0
Pain while dressing in situ (days 1-3 following injury). Pain at dressing change. Assessed via multiple methods - FACES-R/VAS-P/FLACC
Secondary outcome [1] 310619 0
Ease of management of dressing - 5 point Likert scale
Timepoint [1] 310619 0
Day 3 following injury at first dressing change

Eligibility
Key inclusion criteria
Children with acute partial thickness burns presenting to the Department of Emergency Medicine, Royal Children’s Hospital aged 3-15.
Minimum age
3 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age younger than 3 years or older than 16 years
Superficial (erythema only) & full thickness burns
Burns >10% TBSA
Chemical and friction burns
Known sensitivity to silver
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)
The surgical registrar will identify eligible patients and ask if a member of the research team can approach the family and discuss the project. Informed consent will be gained. Sequentially numbered, sealed, opaque envelopes prepared by an independent party will be used for treatment allocation.
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
This is a proof of concept, feasibility pilot study. As this is a pilot study statistical analysis will be limited. Data will be presented as mean (standard deviation) or median (range) where appropriate. Comparison between groups will be undertaken, however the investigators acknowledge the limitations of this given it is a pilot study. Data from this study will be utilised to design a larger prospective RCT if the pilot study determines that the study is feasible.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/09/2014
Actual
Date of last participant enrolment
Anticipated
21/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3013 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 8726 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 289993 0
Commercial sector/Industry
Name [1] 289993 0
Smith and Nephew Australia
Country [1] 289993 0
Australia
Primary sponsor type
University
Name
Queensland Children's Medical Research Institute, University of Queensland
Address
Level Four Foundation Building
Royal Children's Hospital
Herston Road
Herston
Qld 4029
Country
Australia
Secondary sponsor category [1] 288678 0
None
Name [1] 288678 0
Address [1] 288678 0
Country [1] 288678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291702 0
Children's Health Services Queensland HREC
Ethics committee address [1] 291702 0
Ethics committee country [1] 291702 0
Australia
Date submitted for ethics approval [1] 291702 0
16/05/2014
Approval date [1] 291702 0
27/05/2014
Ethics approval number [1] 291702 0
HREC/14/QRCH/78
Ethics committee name [2] 291703 0
University of Queensland HREC
Ethics committee address [2] 291703 0
Ethics committee country [2] 291703 0
Australia
Date submitted for ethics approval [2] 291703 0
03/06/2014
Approval date [2] 291703 0
05/06/2014
Ethics approval number [2] 291703 0
2014000757

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

Contacts
Principal investigator
Name 51622 0
Prof Roy Kimble
Address 51622 0
Department Paediatrics and Child Health
Level 3 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston 4029 Queensland
Country 51622 0
Australia
Phone 51622 0
+61 7 3636 8513
Fax 51622 0
Email 51622 0
[email protected]
Contact person for public queries
Name 51623 0
Kellie Stockton
Address 51623 0
Queensland Children's Medical Institute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston 4029
Queensland
Country 51623 0
Australia
Phone 51623 0
+61 7 3636 1278
Fax 51623 0
Email 51623 0
[email protected]
Contact person for scientific queries
Name 51624 0
Kellie Stockton
Address 51624 0
Queensland Children's Medical Institute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston 4029
Queensland
Country 51624 0
Australia
Phone 51624 0
+61 7 3636 1278
Fax 51624 0
Email 51624 0
[email protected]

No information has been provided regarding IPD availability


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.