Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000451202
Ethics application status
Approved
Date submitted
3/06/2009
Date registered
12/06/2009
Date last updated
21/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Burns And Silver In Children: A comparison of the silver based dressings Aquacell and Acticoat for paediatric burns.
Scientific title
A randomised controlled study of the effect of silver based burns dressings Aquacell and Acticoat on percentage epithelialisation in a paediatric emergency department.
Secondary ID [1] 283953 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BASIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn wounds 236912 0
Condition category
Condition code
Injuries and Accidents 237268 237268 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aquacel Ag will be applied to the wound bed with a 3cm overlap to allow for the dressing to shrink. Telfa (an absorbent cotton fabric bonded on both sides with perforated non-adherent film) will be placed over the Aquacel Ag and then Hypafix will be used to hold the dressing in place.
These patients will not be instructed to moisten the dressing at home.
Patients will be reviewed in 3 days after the initial dressing placement. The Hypafix will be removed, and areas of non-adherence will be trimmed and replaced if still considered to be partial thickness and appropriate for outpatient management. Hypafix will then be re-applied.
Patients will be reviewed at day 10 with dressing removal and photography to allow percentage epithelialisation to be assessed
Intervention code [1] 236701 0
Treatment: Other
Comparator / control treatment
Acticoat3 dressing is applied to the wound bed (blue side down) with a minimum of overlap. The dressing will be moistened with warm water (not saline), and overlapping Hypafix will be used to hold the dressing in place. These patients will be instructed to moisten the dressing three times daily at home with tap water via a spray bottle or shower head.
Patients will be reviewed in 3 days after the initial dressing placement and the Hypafix and Acticoat3 dressings will be removed. These wounds will be visualised, and the wound will be lightly cleaned with saline and re-dressed with Acticoat7 and Hypafix.
Patients will be reviewed at day 10 with dressing removal and photography to allow percentage epithelialisation to be assessed
Control group
Active

Outcomes
Primary outcome [1] 238082 0
Percentage epithelialisation
This will be assessed using comparison of photo at Day 0 and photo 10 days after initial dressing application by a burns surgeon
Timepoint [1] 238082 0
10 days following initial application of dressing
Secondary outcome [1] 242277 0
Number of dressing changes
Assessed using chart review
Timepoint [1] 242277 0
10 days following initial application of dressing

Eligibility
Key inclusion criteria
Partial Thickness Burn (blistering and with normal or increased capillary refill)
Present to Starship Emergency Department within 24 hours of the burn injury
Minimum age
No limit
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Superficial epidermal burn (no blistering)
Full-thickness burns and Deep Partial-thickness burns
Partial-thickness burns > 10% Body surface area
Burns to the perineum, genitalia, face, hands or feet (Aquacel Ag contraindicated)
Burns over major joints
Circumferential Burns
Chemical or Electrical burns
Allergy to silver
Patients referred for evaluation of Non-Accidental-Injury
Patients expecting to reside outside Auckland during the 10 day follow-up period.

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)
Enrollment will occur in the Emergency Department (ED). Once consent has been obtained, sequentially numbered opaque envelopes will be selected that contain treatment allocation information
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study numbers will be assigned sequentially, and randomization will be achieved by generating numerical codes in random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
31/10/2009
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 1825 0
New Zealand
State/province [1] 1825 0
Auckland

Funding & Sponsors
Funding source category [1] 237091 0
Self funded/Unfunded
Name [1] 237091 0
Michael Shepherd
Country [1] 237091 0
New Zealand
Primary sponsor type
Individual
Name
Michael Shepherd
Address
Children's Emergency Department
Starship Children's Hospital
Auckland District Health Board
Private Bag 92024
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 4597 0
None
Name [1] 4597 0
Address [1] 4597 0
Country [1] 4597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239192 0
Northern X or Y Regional Ethics Committee
Ethics committee address [1] 239192 0
Ethics committee country [1] 239192 0
New Zealand
Date submitted for ethics approval [1] 239192 0
15/06/2009
Approval date [1] 239192 0
28/07/2009
Ethics approval number [1] 239192 0
NTX/09/07/061

Summary
Brief summary
This study aims to determine whether Aquacell is a superior silver based dressing compared to Acticoat for paediatric burns managed as an outpatient .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29690 0
Dr Michael Shepherd
Address 29690 0
Children's Emergency Department Starship Children's Hospital Auckland District Health Board Private Bag 92024 Auckland 1142, New Zealand
Country 29690 0
New Zealand
Phone 29690 0
+64 9 3074902
Fax 29690 0
Email 29690 0
[email protected]
Contact person for public queries
Name 12937 0
Michael Shepherd
Address 12937 0
Children's Emergency Department
Starship Children's Hospital
Auckland District Health Board
Private Bag 92024
Auckland 1142, New Zealand
Country 12937 0
New Zealand
Phone 12937 0
+64 9 3074902
Fax 12937 0
Email 12937 0
[email protected]
Contact person for scientific queries
Name 3865 0
Michael Shepherd
Address 3865 0
Children's Emergency Department
Starship Children's Hospital
Auckland District Health Board
Private Bag 92024
Auckland 1142, New Zealand
Country 3865 0
New Zealand
Phone 3865 0
+64 9 3074902
Fax 3865 0
Email 3865 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.