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Trial registered on ANZCTR


Registration number
ACTRN12611000590965
Ethics application status
Not yet submitted
Date submitted
6/06/2011
Date registered
7/06/2011
Date last updated
7/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Biobrane versus Acticoat in the treatment of mid-depth burns in children.
Scientific title
The effect of Biobrane versus Acticoat on the rate of epithelialisation and time to complete healing in mid-dermal paediatric burns: A prospective randomised controlled trial.
Secondary ID [1] 262319 0
nil
Universal Trial Number (UTN)
U1111-1121-9802
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paediatric mid dermal burns 268028 0
Condition category
Condition code
Injuries and Accidents 268157 268157 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The comparison of two dressings in current use - Group 1 -a biosynthetic silicone and nylon fabric bound with porcine collagen (Biobrane) will be dressed with biobrane and acticoat (as per the standard practise) . Dressings will be changed once per week for two weeks at which point a decision will be made regarding the need for grafting (as per the standard practise); Group 2 will have a nano-crystalline silver antimicrobial barrier dressing (Acticoat). This dressing will also be chnaged once per week for two weeks at which point a decision will be made as to whether skin grafting is necessary (as per the standard practise)
Intervention code [1] 266711 0
Treatment: Devices
Comparator / control treatment
In this study there will not be a group which does not receive treatement as patients will all have burns that require some form of treatment or dressing. Therefore the control group is active, ie biobrane group will be compared to acticoat group.
Control group
Active

Outcomes
Primary outcome [1] 266902 0
Determination of wound depth will be an objective measure using a laser doppler scanner. The outcome measure of rate of epitheliasation ie wound healing unfortunatley does remain the clinician's subjective assessment and has been a limiting step for research in this field. Experience is highly relevant for a reliable assessment [1] therefore all burns inlcuded in the study will be assessed by either the Burns Fellow or Burns Staff Specialist. Then correlation of the subjective evaluation of two observers will also be used to imporve the reliability of the assessment. We may also use a Evaporimeter (pending acquisition of the machine) , a device that measures the healing endpoint based on the regeneration of the water loss barrier. This is a simple non invasive way of objectively measuring healing endpoint and has been shown to be an accurate tool [2].


[1]Reliability of subjective wound assessment M.C.T. Bloemen, P.P.M. van Zuijlen, E. Middelkoop Burns Volume 37, Issue 4, June 2011, Pages 566-571
[2] J.S. Surinchak, J.A. Malinowski, D.R. Wilson and H.I. Maibach, Skin wound healing determined by water loss, J Surg Res 38 (3) (1985), pp. 258-262
Timepoint [1] 266902 0
within 4 weeks post randomisation
Secondary outcome [1] 276590 0
presence of infection based on microbiological wound swab taken at time of dressing
Timepoint [1] 276590 0
4 weeks post randomisation
Secondary outcome [2] 276591 0
presence of hypertrophic scars at 3 months post dressing using Vancouver Scar Scale and ultrasound to determine scar depth
Timepoint [2] 276591 0
3 months post randomisation
Secondary outcome [3] 276592 0
data linkage to patient medical records
Timepoint [3] 276592 0
3 months post randomisation
Secondary outcome [4] 276593 0
pain/psychological trauma at dressing change (objective/subjective) measured using the 'Faces' pain scale, a visual analogue scale
Timepoint [4] 276593 0
4 weeks post randomisation

Eligibility
Key inclusion criteria
paediatric mid dermal burns between 5 and 15% total body surface area, consent obtained
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
any burns to face, digits and perineum
any burn not confirmed to be mid-dermal on LDI scan on day two of presentation

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)
All patients with a 5-15% mid-dermal (as determined by LDI) burn requiring review and dressings at The Children’s Hospital at Westmead (CHW) presenting by day 2 of burn, will be eligible for the study. Prior to entry into the study, written consent will be obtained by all patients or their guardians. After consent has been obtained, participants will be randomised into two groups. Group one will be dressed with Biobrane and acticoat and Group two will be dressed with acticoat alone. allocation will be concealed by randomisation by computer . The person who is recruiting will no be aware which group the patient will be allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation will determine the allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267192 0
Hospital
Name [1] 267192 0
The Children's Hospital at Westmead
Country [1] 267192 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Corner of Hawkesbury and Hainsworth St
Westmead NSW
2145
Country
Australia
Secondary sponsor category [1] 266264 0
None
Name [1] 266264 0
Address [1] 266264 0
Country [1] 266264 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269185 0
Ethics committee address [1] 269185 0
Ethics committee country [1] 269185 0
Date submitted for ethics approval [1] 269185 0
25/05/2011
Approval date [1] 269185 0
Ethics approval number [1] 269185 0

Summary
Brief summary
This study will randomise all patients with 5-15% mid dermal burns attending the BPTC for first review with LDI confirmation of a mid-dermal burn into two groups; Group 1 will have Biobrane and Acticoat dressings to burn wounds and group 2 will have the regularly used acticoat dressings alone, in the conventional manner. Burns will undergo standard ward hydrodebridement or OT hydrodebridement (if necessary for analgesia). Biobrane will be secured with hypafix on the ward or rarely, if necessary in OT with staples. Both groups will then be reviewed at regular dressing changes according to the usual practise at CHW for whichever Acticoat is used. Biobrane will be removed at D14 and decision on healing made then clinically and with a Vapourometer. Scar outcome and need for grafting will be assessed as well as cost effectiveness, healing time and amount of pain at dressing changes. We feel that this study may improve clinical care by providing evidence to support the use of Biobrane and the benefits to its use will in the long term outweigh the extra costs involved.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32703 0
Address 32703 0
Country 32703 0
Phone 32703 0
Fax 32703 0
Email 32703 0
Contact person for public queries
Name 15950 0
Seema Menon
Address 15950 0
The Children's Hospital at Westmead
Cnr of Hawkesbury and Hainsworth St
Westmead
NSW 2145
Country 15950 0
Australia
Phone 15950 0
+61 2 9845 1029
Fax 15950 0
Email 15950 0
[email protected]
Contact person for scientific queries
Name 6878 0
Seema Menon
Address 6878 0
The Children's Hospital at Westmead
Cnr of Hawkesbury and Hainsworth St
Westmead
NSW 2145
Country 6878 0
Australia
Phone 6878 0
+61 2 9845 1029
Fax 6878 0
Email 6878 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
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