Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000142831
Ethics application status
Not yet submitted
Date submitted
30/01/2012
Date registered
1/02/2012
Date last updated
8/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Clobetasol Propionate ointment application to grafted burn wound
Scientific title
A pilot randomised double blind, longitudinal placebo control trial to investigate the effects of Clobetasol Propionate ointment on skin grafts for burn wounds.
Secondary ID [1] 279808 0
None
Universal Trial Number (UTN)
U1111-1127-4919
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn wound(s) 285691 0
Grafted burn wounds 285692 0
Condition category
Condition code
Skin 285877 285877 0 0
Other skin conditions
Skin 285878 285878 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
use of a super potent corticosteroid ointment (Clobetasol Propionate 0.05%) on grafted burn wounds.
Clobetasol Propionate ointment applied as the treatment and a common moisturizing ointment as the control.
Dosage of treatment is half fingertip unit i.e.0.25g once daily for 8 weeks, self-administered by participants.
Each patient acts as their own control, by applying the treatment or placebo to a randomized site 1 or 2(crossover). Participants being asked to wash their hands between application of the two ointments to avoid mixing the effect of the two ointments.
The investigator will decide anatomical location of two comparable areas of 3cmx3cm that are accessible for self application of ointment and will mark them as site 1 and site 2.
The jars marked A and B, will be prepared by company and the content is unknown to the investigator and the participant. The investigator then randomly allocate which jar on which site using procedure such as coin-tossing . Then the record for each participant will be made giving code number to the participant. (e.g. 001, jar A- site 1, jar B- site 2).
There is no break in-between application of two ointments during the 8 weeks trial. The two ointments will be applied at the same time for 8 weeks on their allocated sites for comparison record.
Intervention code [1] 284131 0
Treatment: Other
Intervention code [2] 284153 0
Treatment: Drugs
Comparator / control treatment
Common moisturising ointment as called Dermaveen ointment.
it is an active treatment of the burns wound. It doesn't have Clobetasol Propionate base.Dermaveen Moisturizing ointment has a formulation containing natural colloidal oatmeal that gently soothes, protects and hydrates the skin.
Control group
Placebo

Outcomes
Primary outcome [1] 286374 0
>75% reduction in thickening and contracture of scar tissue following grafting of burn wounds.
Demographic data of participants will be collected by co-investigators at the time of recruitment.
Principal investigator will document, assess, and photograph the grafted area on a weekly basis for 8 weeks. Changes to the tested and control areas will be assessed by:
1.Modified Vancouver scale which includes
-Vascularity
-Surface area
-Color
-Contour
-Height
2.Visual analogue scale (VAS) for assessment of the pain and itching
3.Photography: The grafted wound will be photographed every week with bluish background and distance of 20cm.
4.Ultrasound imaging will be conducted before the application on Day 7 and on week 8 visit
Timepoint [1] 286374 0
At six months after randomization
Primary outcome [2] 286375 0
>75% reduction in formation of hypertrophic scarring following grafting of burn wounds
Demographic data of participants will be collected by co-investigators at the time of recruitment
Principal investigator will document, assess, and photograph the grafted area on a weekly basis for 8 weeks. Changes to the tested and control areas will be assessed by:
1.Modified Vancouver scale which includes.
-Vascularity
-Surface area
-Color
-Contour
-Height
2.Visual analogue scale (VAS) for assessment of the pain and itching
3.Photography: The grafted wound will be photographed every week with bluish background and distance of 20cm.
4.Ultrasound imaging will be conducted before the application on Day 7 and on week 8 visit
Timepoint [2] 286375 0
At six months after randomization
Secondary outcome [1] 295710 0
>75% reduction in secondary symptoms such as itch and pain

This is done by an expert assessor each week for 8 weeks after recruitment using Visual analogue scale (VAS) for assessment of the pain and itching.
Timepoint [1] 295710 0
At six months after randomization

Eligibility
Key inclusion criteria
1. Full thickness burn wound with grafted skin
2. Anatomical location of two areas of 3cm x 3cm that is comparable and accessible for self application of ointment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Co morbidity such as Type 1 and 2 Diabetes
2. Age limit <18 and >65
3. Inability to provide consent
4. Non-English speaking
5. Mental health and reduced cognizance
6. Inability to attend clinic or review process
7. Greater than 25% total body surface area (TBSA)

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)
1.Identify eligible patient (check inclusion/exclusion criteria) on initial presentation to the burns clinic or burns unit.
2.Obtain written informed consent
3.Allocate Subject Trial Number by co-investigator
4.The investigator will allocate two sites of 3cm×3 cm of grafted skin wounds and decide which one is 1 or 2.
5.The participant will receive two jars of ointment labeled A and B. These jars will be prepared by the pharmacist and will be allocated as jar A and B. Only The independent assessor who is involved in this study will have a concealed envelope from the pharmacy naming the content of jar A and jar B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method to be used to create the random order for the allocation of subjects into different groups is simple randomisation by using procedures such as coin-tossing and dice-rolling.
1.All patients in the trial will have burns that require a skin graft as part of their treatment. Two sites of 3cm×3 cm of grafted skin wounds called site 1 and 2 will be identified by the investigators.
2.The participant will receive two jars of ointment labeled A and B.
3.The participant will apply ointment labeled A on site 1, and ointment labeled B on site 2.
4.The investigator will allocate the sites and decide which one is 1 or 2.
5.Neither the participant nor the assessor will know which ointment is the Clobetasol and which is the moisturiser.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284593 0
Hospital
Name [1] 284593 0
Concord Repatriation General Hospital
Country [1] 284593 0
Australia
Primary sponsor type
Hospital
Name
Burns Unit
Address
Concord Hospital
Concord rd, Hospital st.
Concord, NSW 2139
Country
Australia
Secondary sponsor category [1] 283512 0
None
Name [1] 283512 0
Address [1] 283512 0
Country [1] 283512 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286579 0
Human Research Ethics Committee
CRGH Sydney Local Health District
Ethics committee address [1] 286579 0
Concord road,
Hospital street,
Concord Hospital
Concord, NSW 2139
Ethics committee country [1] 286579 0
Australia
Date submitted for ethics approval [1] 286579 0
24/01/2012
Approval date [1] 286579 0
Ethics approval number [1] 286579 0
HREC/11/CRGH/252

Summary
Brief summary
Burn injuries result in pain, inflammation and destruction of skin cells. Skin grafting will be required when the depth of the injury destroys the deeper skin layers. Despite grafting, the burn injury continues to produce inflammatory chemicals or mediators. These mediators result in a thickened and raised scar with increased sensitivity and itching.
The purpose of this research is to see if Clobetasol propionate can reduce the inflammatory mediators thereby reducing active scar tissue formation.
Trial website
None
Trial related presentations / publications
Presentation for master thesis at University of Sydney.
Presentation at conferences and publication in journals.
Public notes

Contacts
Principal investigator
Name 33691 0
Address 33691 0
Country 33691 0
Phone 33691 0
Fax 33691 0
Email 33691 0
Contact person for public queries
Name 16938 0
Rae Johnson
Address 16938 0
Burns Unit
Concord Hospital
Concord rd, Hospital st.
Concord, NSW 2139
Country 16938 0
Australia
Phone 16938 0
+61 2 9767 7798
Fax 16938 0
Email 16938 0
[email protected]
Contact person for scientific queries
Name 7866 0
Prof.Peter Maitz
Address 7866 0
Burns Unit
Concord Hospital
Concord rd, Hospital st.
Concord, NSW 2139
Country 7866 0
Australia
Phone 7866 0
+61 2 9767 7775
Fax 7866 0
Email 7866 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.