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Trial registered on ANZCTR


Registration number
ACTRN12614000886684
Ethics application status
Approved
Date submitted
30/06/2014
Date registered
20/08/2014
Date last updated
20/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Skin Tear Project: The effectiveness of a skin moisturising cleanser as compared to usual skin care cleansing interventions, for reducing skin tear incidence
Scientific title
In residential aged care facility patients, does a skin moisturising cleanser when used during regular bathing and in addition to either twice daily moisturiser or usual care reduce the incidence of skin tears
Secondary ID [1] 284881 0
NIL
Universal Trial Number (UTN)
U1111-1158-4481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin tears 292261 0
Condition category
Condition code
Injuries and Accidents 292615 292615 0 0
Other injuries and accidents
Skin 292616 292616 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A generic brand of skin moisturising cleanser will be used during regular bathing. The ingredients in the commercially available moisturising cleanser are as follows:
GLYCERIN
AQUA
(WATER)
SODIUM LAUROYL
SARCOSINATE
LAURYL
BETAINE
DISODIUM
COCOAMPHODIACETATE
SODIUM COCOYL
ISETHIONATE
ACRYLATES / C10-30 ALKYL ACRYLATE
CROSSPOLYMER
STYRENE/ACRYLATES
COPOLYMER
AMINOMETHYL PROPANOL
The percentage of these ingredients in this product is commercial in confidence and as this is an over the counter cosmetic product rather than a drug with actives, it is considered not applicable.

The moisturising cleanser will be used during regular bathing of consenting residents in the intervention facilities. The product will be rinsed from the skin. Residents will either be assisted by nurses or care staff with bathing and those who can bath independently will be instructed in the use of the cleanser.

Residents’ preference for bathing frequency will be adhered to, and some residents prefer to be bathed daily and some second daily. The cleanser will be used for 6 months.

The use of the product will be monitored by the care staff and project coordinator. The cleanser will be provided at no cost.
Intervention code [1] 289665 0
Prevention
Intervention code [2] 289666 0
Treatment: Other
Comparator / control treatment
Routine skin care practices as assessed from a pre intervention observational period of 6 months.
Routine skin care practices for residents’ bathing across all facilities will be recorded during the month prior to the intervention. Currently there is no standardised cleanser or soap used for bathing in the facilities. It is anticipated that a variety of soaps and cleansers will be found to be comprise routine skin care across all facilities prior to the intervention. The residents’ preference for bathing frequency will be adhered to and this is anticipated to be daily, second daily or other. Residents in the control sites will continue to use their usual soap or cleanser. Monitoring of the usual skin care practices (soap or cleanser) across the control sites will be ongoing.
The consenting residents in the intervention group will be bathed or bath independently using the skin moisturising cleanser. The residents in the control group will continue to adhere to their usual practice and products for bathing.
Control group
Active

Outcomes
Primary outcome [1] 292455 0
Skin tear incidence will be determined monthly and averaged over 6 months the monthly incidence will be: [total skin tears / (number days / months) by 1000]
Timepoint [1] 292455 0
At baseline and 6 months
Primary outcome [2] 292456 0
Skin tears will be identified and classified using the STAR Skin Tear Classification and the anatomical location and activities associated with the skin tear occurrence will be monitored.
Timepoint [2] 292456 0
At baseline and 6 months
Secondary outcome [1] 308988 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] 308988 0
At baseline and 6 months
Secondary outcome [2] 308989 0
Cost effectiveness of the intervention

The cost analysis component of the economic evaluation will include identifying (i) the quantity and cost of the cleanser lotion used and (ii) staff time spent in performing the intervention bathing procedures and (iii) the costs associated with skin tear management (care time and medical consumables). Total costs for the cleanser intervention groups will be compared with total costs for the control groups, to determine the potential cost savings generated by a reduction in skin tear incidence rate. The outcome used to measure the clinical effectiveness of the intervention will be the number of skin-tear-free days of residents over the study period. This will be measured by prospectively monitoring the time to healing of skin tears and applying the number of days retrospectively to the skin tear incidence rate for each group. Average cost-effectiveness, measured as the cost per skin-tear-free day, will be calculated for all groups.
Timepoint [2] 308989 0
Pre intervention and post intervention (6 months)

Eligibility
Key inclusion criteria
Resident of aged care facility who consent to participate
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing dermatological condition - Current use of steroid creams or prescribed skin creams - GP refusal to participate or respite participant

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 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 usual care. 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)
The twenty six facilities will be sorted into pairs matched in terms of high or low care and as closely as possible in terms of bed numbers. One member of each of the thirteen matched pairs of facilities will then be randomised to the intervention.

Simple cluster randomisation of facilities was conducted. Randomisation was performed by an independent person employed by the aged care organisation. The facilities were matched for bed numbers and acuity (either high or low care). The names of a matched pair of facilities were written on a piece of paper and placed into a container, which was shaken. The first name of a facility from each matched pair, drawn from the container was randomised to the intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A 1 month retrospective review of resident skin tears in the participating facilities will be included.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
28/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
868
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8330 0
6163 - Bibra Lake
Recruitment postcode(s) [2] 8331 0
6011 - Cottesloe
Recruitment postcode(s) [3] 8332 0
6012 - Mosman Park
Recruitment postcode(s) [4] 8333 0
6232 - Eaton
Recruitment postcode(s) [5] 8334 0
6024 - Greenwood
Recruitment postcode(s) [6] 8337 0
6060 - Dog Swamp

Funding & Sponsors
Funding source category [1] 289476 0
Other Collaborative groups
Name [1] 289476 0
Wound Management Innovation CRC
Country [1] 289476 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987, Perth
Western Australia. 6845
Country
Australia
Secondary sponsor category [1] 288162 0
Charities/Societies/Foundations
Name [1] 288162 0
Silver Chain
Address [1] 288162 0
Silver Chain House
6 Sundercombe Street
Osborne Park WA 6017
Country [1] 288162 0
Australia
Other collaborator category [1] 278017 0
Commercial sector/Industry
Name [1] 278017 0
Bethanie AgedCare Inc
Address [1] 278017 0
PO Box 79, Claremont WA 6910
Country [1] 278017 0
Australia
Other collaborator category [2] 278018 0
Commercial sector/Industry
Name [2] 278018 0
Amana Living
Address [2] 278018 0
541 Hay Street, Subiaco WA 6008
Country [2] 278018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291234 0
Curtin University
Ethics committee address [1] 291234 0
Ethics committee country [1] 291234 0
Australia
Date submitted for ethics approval [1] 291234 0
23/02/2014
Approval date [1] 291234 0
05/03/2014
Ethics approval number [1] 291234 0
HR 28/2014

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

Contacts
Principal investigator
Name 49430 0
Prof Keryln Carville
Address 49430 0
School of Nursing & Midwifery Curtin University GPO Box U1987 Perth WA
6845
Country 49430 0
Australia
Phone 49430 0
+61 (0)402792324
Fax 49430 0
Email 49430 0
K.Carville@curtin.edu.au
Contact person for public queries
Name 49431 0
Keryln Carville
Address 49431 0
School of Nursing & Midwifery Curtin University GPO Box U1987 Perth WA
6845
Country 49431 0
Australia
Phone 49431 0
+61 (0)402792324
Fax 49431 0
Email 49431 0
K.Carville@curtin.edu.au
Contact person for scientific queries
Name 49432 0
Gavin Leslie
Address 49432 0
School of Nursing & Midwifery Curtin University GPO Box U1987 Perth WA
6845
Country 49432 0
Australia
Phone 49432 0
+61 8 9266 2070
Fax 49432 0
Email 49432 0
g.leslie@curtin.edu.au

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

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Documents added automatically
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