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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
Gender
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
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)
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
Address [1] 289993 0
Healthcare Division
PO Box 242
Mount Waverley VIC 3149
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
Level 3 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston 4029
Qld
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
University Queensland
St Lucia 4067
Qld
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
The ultimate goal of burn wound management is to promote early healing as this has considerable influence on the long term quality and appearance of scarring. Negative pressure wound therapy (NPWT) is a device that is applied to a wound to ultimately help promote healing. It is widely used in both hospitals and the home on a wide range of wounds. A dressing is applied to the wound bed
and covered with a transparent film dressing and attached to the therapy device using tubing and a canister. A
number of studies have demonstrated improved graft take following split skin graft when NWPT was used
compared to standard dressings. However, there is very little information regarding the use of NWPT as a primary
treatment for burns with respect to wound progression and pain management. A small number of studies have
demonstrated improvement in acute burn wounds with the application of NPWT in the first 48 - 72 hours following
injury. In addition, clinically we have seen a reduction in pain with the use of NPWT.
The aim of this pilot study is to determine the feasibility of the novel application of NPWT on acute burn wounds. The
outcomes of interest being pain, burn wound progression and healing.
All children presenting to the Royal Children's Hospital Department of Emergency Medicine with a partial thickness
burn injury aged 3 - 15
years of age will be considered for the study. Treating surgical registrars of all children meeting the inclusion/exclusion criteria presenting to the Royal Children’s Hospital, Brisbane will determine eligibility for enrolment in the study. With the parent/caregivers permission an investigator aligned with the study will
discuss the study with the parents/caregivers and seek informed consent. Once informed consent is obtained
participants will be randomised to one of two treatment groups (standard dressings or standard dressings plus
NPWT). Dressings (+/negative pressure depending on group allocation) will be changed at day three post burn
injury. Following day three all children will be managed with standard dressings until full re epithelialisation or
grafting. Negative pressure will not be reapplied from day three onwards.
Outcome measures include burn wound progression measured using laser Doppler imaging on day 0 and day 3,
wound healing and pain.
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
royk@uq.edu.au
Contact person for public queries
Name 51623 0
Dr 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
k.stockton@uq.edu.au
Contact person for scientific queries
Name 51624 0
Dr 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
k.stockton@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results