Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000677909
Ethics application status
Approved
Date submitted
4/07/2011
Date registered
5/07/2011
Date last updated
18/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Australian Study assessing the effects of Avene Thermal Water Spray in patients with recessive dystrophic epidermolysis bullosa
Scientific title
An Australian Study assessing the effects of Avene Thermal Water Spray in patients with recessive dystrophic epidermolysis bullosa
Secondary ID [1] 262550 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidermolysis Bullosa 268215 0
Condition category
Condition code
Skin 268343 268343 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Avene thermal water spray is used to clean all wounds and to clean the skin. This is applied by the patient/carer instead of normal bathing techniques. The frequency will depend on the frequency of bathing and is at the discretion of the patient or carer. Duration of treatment is 6 months.
Intervention code [1] 266895 0
Lifestyle
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269117 0
change in size of the selected wounds
Timepoint [1] 269117 0
6 months: Visitrak machine to measure size of wounds
Primary outcome [2] 269118 0
colonisation of wounds: clincial assessment in addition to microbiological methods
Timepoint [2] 269118 0
6 months
Primary outcome [3] 269119 0
development of new erosions: clinical assessments
Timepoint [3] 269119 0
6 months
Secondary outcome [1] 276957 0
improved quality of life: QOLEB qustionnaire at regular intervals (baseline, weeks 12 and 24)
Timepoint [1] 276957 0
baseline, weeks 12 and 24
Secondary outcome [2] 276958 0
decrease in pain scores: which are assessed at regular intervals (baseline, weeks 12 and 24)
Timepoint [2] 276958 0
baseline, weeks 12 and 24
Secondary outcome [3] 276959 0
reduction in antibiotic use: this will be assessed at regular intervals (baseline, weeks 12 and 24)
Timepoint [3] 276959 0
baseline, weeks 12 and 24
Secondary outcome [4] 276960 0
decrease in new wound formation rate compared to previous 3 months: using questionnaires, Vistrak machine and clinical photographs
Timepoint [4] 276960 0
6 months
Secondary outcome [5] 276961 0
safety and adverse events: eg. infection- assessed clinically as well as microbiological means
Timepoint [5] 276961 0
6 months
Secondary outcome [6] 276962 0
change in EB severity score: this will be assessed at regular intervals
(baseline, weeks 12 and 24)
Timepoint [6] 276962 0
baseline, weeks 12 and 24
Secondary outcome [7] 276963 0
reduction in hospitalisations: this will be assessed at regular intervals
(baseline, weeks 12 and 24)
Timepoint [7] 276963 0
baseline, weeks 12 and 24

Eligibility
Key inclusion criteria
Diagnosis of RDEB confirmed by IFM/EM
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to provide consent
pregnant; breastfeeding
current participation in another study or trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267363 0
Self funded/Unfunded
Name [1] 267363 0
Premier Dermatology
Country [1] 267363 0
Australia
Primary sponsor type
Individual
Name
Professor Dedee Murrell
Address
17 Kensington Street
Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 266430 0
None
Name [1] 266430 0
Address [1] 266430 0
Country [1] 266430 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To determine the efficacy and safety of the Avene Thermal Spring Water (ATSW) in wound healing in patients with recessive dystrophic epidermolysis bullosa. The hypothesis is that the ATSW, instead of bathing, will result in reduced number of infections and improved wound healing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32818 0
Address 32818 0
Country 32818 0
Phone 32818 0
Fax 32818 0
Email 32818 0
Contact person for public queries
Name 16065 0
Dr Benjamin Daniel
Address 16065 0
17 Kensington Street
Kogarah
NSW 2217
Country 16065 0
Australia
Phone 16065 0
+61291132543
Fax 16065 0
Email 16065 0
[email protected]
Contact person for scientific queries
Name 6993 0
Professor Dedee Murrell
Address 6993 0
17 Kensington Street
Kogarah
NSW 2217
Country 6993 0
Australia
Phone 6993 0
+61291132543
Fax 6993 0
Email 6993 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.