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Trial registered on ANZCTR


Registration number
ACTRN12613000105741
Ethics application status
Approved
Date submitted
25/01/2013
Date registered
25/01/2013
Date last updated
29/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to compare the effect of three burns dressings on burns in children
Scientific title
The effect of three different burns dressings on time to re-epithelialisation of partial thickness burns in children: a randomised control trial
Secondary ID [1] 281825 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric partial thickness burns 288174 0
Condition category
Condition code
Injuries and Accidents 288536 288536 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comparison of three dressings currently being used. Group 1: Burn wound will be dressed with Acticoat (a silver containing dressing without a silicone skin interface). Participants will have their dressing changed twice weekly until the wound re-epithelialises or grafting is required; Group 2: Burn wound will be dressed with Acticoat and Mepitel (a silicone coated nylon grid dressing) Participants will have their dressing changed twice weekly until the wound re-epithelialises or grafting occurs; Group 3: Burn wound will be dressed with Mepilex Ag (soft foam, silver containing dressing with safe-tac technology). Participants will have their dressing changed twice weekly until the wound re-epithelialises or grafting occurs.
Intervention code [1] 286379 0
Treatment: Devices
Comparator / control treatment
There is no placebo group in this study as it would be unethical not to dress burn wounds or to use an older, inferior dressing. Therefore the Acticoat, Acticoat and Mepitel and MepilexAg groups will be compared to each other as active control groups.
Control group
Active

Outcomes
Primary outcome [1] 288696 0
Time (days) to re-epithelialisation of burn wound will be measured using two methods. 1: The VisitrakTM (Smith and Nephew) digital device will be used (by an unblinded assessor) to calculate wound area and assess wound re-epithelialisation; 2: Digital photography (3D LifeViz camera software, Quantificare) will be used by a blinded assessor (burns surgeon not involved in patient's care) to measure the area of re-epithelialisation. Both measurement methods to be undertaken at each dressing change (every 3 days).
Timepoint [1] 288696 0
Every 3 days (each dressing change) after intervention commencement until wound is re-epithelialised.
Primary outcome [2] 289065 0
Impact of dressings on pain and anxiety during changes: Child self report using the Revised Faces scale (FACES); Caregiver-report (or self-report of child 8 years or older) of child's level of pain using a 0-10 visual analogue scale. Pulse rate, respiratory rate and analgesia requirements also to be recorded. All measurements to be taken by a blinded assessor at each dressing change (every 3 days).
Timepoint [2] 289065 0
Every 3 days (each dressing change) after intervention commencement until wound is re-epithelialised.
Secondary outcome [1] 300779 0
Scar assessment using the Patient and Observer Scar Assessment Scale v2 (POSAS); digital photography; and ultrasound to determine scar thickness and ratio of scar thickness to normal adjacent skin. Measures taken by blinded assessor from point of healing.
Timepoint [1] 300779 0
Point of healing, 3 and 6 months post-healing.
Secondary outcome [2] 300780 0
Effect of wound dressing on physical functioning using parent/caregiver and child (>8years) self report on a visual analogue scale.
Timepoint [2] 300780 0
Every 3 days (each dressing change).
Secondary outcome [3] 300781 0
Grafting of wound required (yes/no)
Timepoint [3] 300781 0
Intervention commencement
Secondary outcome [4] 300782 0
Cost effectiveness of each dressings trialled (number of nurses required at each dressing change, time taken for procedure, amount and type of dressing used, grafting requirements, scar management costs (clinic attendance and use of resources)
Timepoint [4] 300782 0
Every 3 days (each dressing change) and at point of healing, 3 and 6 months post-healing
Secondary outcome [5] 300783 0
Qualitative data from nursing staff on each dressing combination (e.g. ease of use).
Timepoint [5] 300783 0
Conclusion of trial

Eligibility
Key inclusion criteria
Children with acute superficial partial to deep partial thickness burn injuries <10% TBSA (total body surface area), presenting to Royal Children's Hospital, Brisbane within 72hours of injury.
Minimum age
No limit
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Superficial and full thickness burns
Burns >10% TBSA
Known sensitivity to silver
Chemical and friction burns
Non-English speaking
Cognitive impairment

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)
Treating physicians/nursing staff of all children meeting the inclusion/exclusion criteria presenting the to the Royal Children's Hospital, Brisbane will determine eligibility for enrolement in the study. An investigator aligned with the study will discuss the study with parents/caregivers/child and seek informed consent. Participants will then be randomised into one of the three treatment groups. Allocated concealment will be undertaken by the use of sealed, opaque, idential and serially numbered envelopes prepared by an independent party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Demographic and baseline outcome measures will be compared.
An ANOVA or suitable non-parametric test will compare outcome measures between groups.
Analysis will be by intention to treat and per protocol.

Recruitment
Recruitment status
Active, not 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] 478 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 6216 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 286623 0
Commercial sector/Industry
Name [1] 286623 0
Molnlycke Healthcare Australia
Address [1] 286623 0
Suite 1.01
10 Tilley Lane
Frenchs Forest NSW 2086
Country [1] 286623 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Sir Fred Schonell Dr
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 285397 0
None
Name [1] 285397 0
Address [1] 285397 0
Country [1] 285397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288693 0
Children's Health Services Human Research Ethics Committee
Ethics committee address [1] 288693 0
Ethics committee country [1] 288693 0
Date submitted for ethics approval [1] 288693 0
Approval date [1] 288693 0
Ethics approval number [1] 288693 0
EC00175
Ethics committee name [2] 288694 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 288694 0
Ethics committee country [2] 288694 0
Date submitted for ethics approval [2] 288694 0
Approval date [2] 288694 0
Ethics approval number [2] 288694 0
EC00179

Summary
Brief summary
At the Royal Children's Hospital in Brisbane the standard of care in burns dressings for small to medium partial thickness burns has changed over the years. Currently, silver containing dressings are used to prevent infection and promote healing. However despite the large number of burns dressings available on the market, very few high level trials have been conducted in children or adults. This study aims to determine the effect of various silver and silicone containing burns dressings for the treatment of partial thickness burns in children.

The study hypothesises that:
1. Rate of healing, need for grafting and subsequent scarring from a burn wound is partly determined by the choice of dressing used.
2. The choice of dressings used can partly assist with pain and anxiety strategies during dressing change procedures; and impacts on a child's comfort and engagement in activities.
3. The dressing which best fulfils the above qualities will also be the most cost effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37270 0
Prof Roy Kimble
Address 37270 0
Queensland Children's Medical Research Insitute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 37270 0
Australia
Phone 37270 0
+61 7 3636 8111
Fax 37270 0
Email 37270 0
royk@uq.edu.au
Contact person for public queries
Name 37271 0
Prof Roy Kimble
Address 37271 0
Queensland Children's Medical Research Insitute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 37271 0
Australia
Phone 37271 0
+61 7 3636 8111
Fax 37271 0
Email 37271 0
royk@uq.edu.au
Contact person for scientific queries
Name 37272 0
Prof Roy Kimble
Address 37272 0
Queensland Children's Medical Research Institute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 37272 0
Australia
Phone 37272 0
+61 7 3636 8111
Fax 37272 0
Email 37272 0
royk@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary