Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001089921
Ethics application status
Approved
Date submitted
29/09/2011
Date registered
20/10/2011
Date last updated
3/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of a twice daily skin moisturising regimen as compared to usual skin care interventions, for reducing the incidence and severity of skin tear injuries in residential aged care facility patients.
Scientific title
In residential aged care facility patients, does a twice daily skin moisturising regimen reduce the severity and incidence of skin tears when compared to usual skin care practices?
Secondary ID [1] 262965 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin tears 270689 0
Condition category
Condition code
Injuries and Accidents 270863 270863 0 0
Other injuries and accidents
Skin 279164 279164 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A generic brand skin moisturising lotion will be applied twice daily to the limbs of consenting residents in aged care facilities for 6 months.
Intervention code [1] 269305 0
Prevention
Intervention code [2] 269557 0
Treatment: Other
Comparator / control treatment
Routine skin care practices as assessed from a pre intervention observational period of 6 months.
Control group
Active

Outcomes
Primary outcome [1] 279543 0
Skin Tear Incidence. Skin tears will be identified and classified using the STAR tool as well as having site of tear noted.
Timepoint [1] 279543 0
At baseline and 6 months
Primary outcome [2] 279544 0
Skin Tear Severity. Using the STAR tool.
Timepoint [2] 279544 0
At Baseline and six months
Secondary outcome [1] 287871 0
Skin tear location and management. A pre defined list on the data collection tool covers all potential skin tear locations. A treatment options list is included.
Timepoint [1] 287871 0
At baseline and six months
Secondary outcome [2] 287872 0
Identify the barriers and enablers to skin moisturising regimens in residential aged care facilities. This will be assessed through a series of pre and post intervention focus groups and reviews of site documentation.
Timepoint [2] 287872 0
Pre intervention and post intervention (6 months)

Eligibility
Key inclusion criteria
Resident of aged care facility
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-exisitng dematalogoical condition
Current use of steriod creams or prescribed skim creams
GP refusal to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants at a randomised facility (block randomisation) who meet inclusion criteria will be approached to consent to have the intervention used. Participants at a non intervention site will have no change to routine practice. Staff applying the intervention work within the randomised site and don't crossover. Strictly speaking allocation concealment is not used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fourteen aged care sites will be matched for care dependency using nationally defined criteria then randomised to either the intervention or standard practice using simple randomisations procedures. Residents within each facility will then with consent receive the intervention, or continue in non intervention sites with standard care.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A 6 month retrospective review of resident skin tears in the participating facilities will be included as well as a pre-intervention review of skin care practices and a post intervention review of skin care practices.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/09/2011
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
31/03/2012
Date of last data collection
Anticipated
Actual
28/09/2012
Sample size
Target
840
Accrual to date
Final
984
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 4480 0
6163
Recruitment postcode(s) [2] 4481 0
6011
Recruitment postcode(s) [3] 4482 0
6012
Recruitment postcode(s) [4] 4483 0
6232
Recruitment postcode(s) [5] 4484 0
6024
Recruitment postcode(s) [6] 4485 0
6060

Funding & Sponsors
Funding source category [1] 269772 0
Other Collaborative groups
Name [1] 269772 0
Wound Management Innovation CRC
Country [1] 269772 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987, Perth
Western Australia. 6845
Country
Australia
Secondary sponsor category [1] 268812 0
Charities/Societies/Foundations
Name [1] 268812 0
Silver Chain
Address [1] 268812 0
Silver Chain House
6 Sundercombe Street
Osborne Park WA 6017
Country [1] 268812 0
Australia
Other collaborator category [1] 252241 0
Commercial sector/Industry
Name [1] 252241 0
Bethanie AgedCare Inc
Address [1] 252241 0
PO Box 79, Claremont WA 6910
Country [1] 252241 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271797 0
Bethanie Inc
Ethics committee address [1] 271797 0
Ethics committee country [1] 271797 0
Australia
Date submitted for ethics approval [1] 271797 0
Approval date [1] 271797 0
03/05/2011
Ethics approval number [1] 271797 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33098 0
Prof Keryln Carville
Address 33098 0
Silver Chain House 6 Sundercombe Street Osborne Park WA 6017
Country 33098 0
Australia
Phone 33098 0
+61 8 9242 0242
Fax 33098 0
Email 33098 0
[email protected]
Contact person for public queries
Name 16345 0
Keryln Carville
Address 16345 0
Silver Chain House
6 Sundercombe Street
Osborne Park WA 6017
Country 16345 0
Australia
Phone 16345 0
+61 8 9242 0242
Fax 16345 0
Email 16345 0
[email protected]
Contact person for scientific queries
Name 7273 0
Gavin Leslie
Address 7273 0
School of Nursing & Midwifery
Curtin University
GPO Box U1987
Perth WA 6845
Country 7273 0
Australia
Phone 7273 0
+61 8 9266 2070
Fax 7273 0
Email 7273 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.