Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001360707p
Ethics application status
Not yet submitted
Date submitted
10/10/2022
Date registered
24/10/2022
Date last updated
24/10/2022
Date data sharing statement initially provided
24/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
To explore the effectiveness of barrier wipes on preventing pressure injuries (PI) for consumers in the residential aged care sector.
Scientific title
A single blinded, multi-centre randomised controlled trial (RCT) will be conducted to investigate the effectiveness of a twice-daily application of a barrier wipe (contiplan) on the incidence of pressure injuries (PI) in residential aged care facilities (RACF).
Secondary ID [1] 308036 0
Nil known
Universal Trial Number (UTN)
U1111-1282-9861
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injury 327720 0
Condition category
Condition code
Skin 324792 324792 0 0
Other skin conditions
Public Health 325015 325015 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of a twice daily barrier wipe to the heels , sacrum and buttocks of participants living in aged care homes. Application takes approximately 2 minutes to apply.

The intervention in this study is the use of a barrier wipe applied twice daily to the participants skin in conjunction with usual care. The barrier wipe will be applied to the heel, sacrum, and buttock areas after bathing in the morning and before retiring at night. These products will be distributed to the Residential Aged Care Facilities (RACFs) at the commencement of the study and monitored for re-stocking by the service managers weekly. The barrier wipe that has been selected is based on best fit for aged skin as per the listed ingredients and will be pH neutral as recommended for this age group.

Barrier wipes will have the following characteristics:
• Dermatologically tested
• Lanolin free
• Skin neutral pH
• Contain dimethicone
• Long lasting
• Hypoallergenic
• Non-cytotoxic
• Alcohol free, sting free.

Barrier wipes will be used with an aim to provide a standard and consistent approach to the minimum application of a twice daily use - 3 wipes will be used per participant, per application. The trial will continue for 8 months. Using barrier wipes assists in the assessment of compliance with the compliance (fidelity) as wipe usage can be easily measured by counting the amount used and distributed. The intervention trial has been informed by reviewing the available literature and noting a gap in the prevention of pressure injuries.
Education and training will be provided via Microsoft teams and face to face (20min sessions) to all facilities and their staff, as well as participants on the application of the product, what to do should any adverse reactions occur and who to contact for further questions. Care staff within each service will deliver the procedure as this is part of participant care as standard practice. Training will be provided monthly by the investigators.
Intervention code [1] 324489 0
Prevention
Comparator / control treatment
The control group will continue to be usual care. Providing support surfaces to participants and pressure area care. As deemed normal for that participant.

Pressure area care is described as repositioning every 2 hours or as indicated for the participant and providing support surfaces such as alternating mattresses and comfort chairs such as 'tub chairs' designed for offloading pressure.
Control group
Active

Outcomes
Primary outcome [1] 332628 0
The incidence of pressure injuries (PIs) to sacrum, buttocks, and heels per participant over 8 months. Each individual PI will be included. This will occur by the clinical staff who will record this on a skin assessment monthly or sooner if pressure injuries noted.
Timepoint [1] 332628 0
All participants' skin will be assessed on entering the trial and then monthly thereafter. The clinical team will attend to this using skin assessments. The care team will check skin at each encounter of showering and dressing and will report to the clinical team any skin changes.
Secondary outcome [1] 414114 0
The time in days to the first PI over 8 months will be assessed by the clinical staff
Timepoint [1] 414114 0
Daily assessment by care staff and reported to clinical staff will occur for 8 months post commencement of intervention

Eligibility
Key inclusion criteria
• 65 years or older at the time of consent
• Living in a RACF
• Limited mobility defined as being able to stand to pivot transfer or less
• Ability to provide informed consent or informed consent obtained from the legal person responsible
• Those defined at risk for pressure injuries based off Waterlow scores -a score of 10 or higher (pressure injury risk assessment tool).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Below 65 years old
• Any person with a current pressure injury to heels, buttocks, or sacrum. The reason for this is due to the inability to apply barrier wipes to a wound such as a PI.
• Not living in an enrolled RACF
• Those who are palliating and at end of life
• Those with sensitivities or allergies to any ingredients in the barrier wipe
• Those that are fully mobile or able to weight bear and mobilise and able to walk more than a metre. The rationale for this is that people who are fully mobile are at less risk for PIs.

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)
Each week, for all participants who have consented that week, participants will be randomised in a 1:1 ratio and allocated to either the control or intervention group by an offsite researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher will prepare a concealed allocation schedule by computer randomisation. The lead researcher will have no further access to participant data.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The incidence of PIs reported in the literature is 1.33 (95% CI =1.29–1.37) per 1000 consumer days, with a standard deviation of 1.65 (Jorgensen et al, 2018). This is re-calculated to be 0.49 PIs per year (SD 0.60), assuming 365 days per year. For an eight-month study, we assumed a baseline incidence of 0.33, reducing to 0.196 for the intervention group, based on a relative reduction of 40%. A sample of 330 in each arm, achieves 80% power, with a type one error of 5%. Attrition needs to be considered in the context of the participants and setting. Allowing for an attrition rate of 30%, a sample of 429 is required in both intervention and control arms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2022
Actual
Date of last participant enrolment
Anticipated
7/12/2022
Actual
Date of last data collection
Anticipated
15/07/2023
Actual
Sample size
Target
858
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 312296 0
Other
Name [1] 312296 0
Uniting
Country [1] 312296 0
Australia
Funding source category [2] 312404 0
University
Name [2] 312404 0
University of Newcastle
Country [2] 312404 0
Australia
Funding source category [3] 312405 0
Commercial sector/Industry
Name [3] 312405 0
GAMA Healthcare Australia
Country [3] 312405 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Faculty of Health and Medicine, School of Nursing and Midwifery
Level 9, 77a Holden St, Gosford Hospital, Gosford NSW 2250
Country
Australia
Secondary sponsor category [1] 313973 0
None
Name [1] 313973 0
Address [1] 313973 0
Country [1] 313973 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311665 0
University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 311665 0
Ethics committee country [1] 311665 0
Australia
Date submitted for ethics approval [1] 311665 0
17/11/2022
Approval date [1] 311665 0
Ethics approval number [1] 311665 0

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

Contacts
Principal investigator
Name 121914 0
Mrs Hayley Ryan
Address 121914 0
Hayley Ryan
Newcastle University
PO Box 3143, Glendale, 2285 NSW
Country 121914 0
Australia
Phone 121914 0
+61 0408547295
Fax 121914 0
Email 121914 0
[email protected]
Contact person for public queries
Name 121915 0
Hayley Ryan
Address 121915 0
Hayley Ryan
Newcastle University
PO Box 3143, Glendale, 2285 NSW
Country 121915 0
Australia
Phone 121915 0
+61 0408547295
Fax 121915 0
Email 121915 0
[email protected]
Contact person for scientific queries
Name 121916 0
Hayley Ryan
Address 121916 0
Hayley Ryan
Newcastle University
PO Box 3143, Glendale, 2285 NSW
Country 121916 0
Australia
Phone 121916 0
+61 0408547295
Fax 121916 0
Email 121916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, 5 years post publication
Available to whom?
anyone who wishes to access it will be reviewed on a case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17186Study protocol    384714-(Uploaded-26-09-2022-18-35-48)-Study-related document.pdf



Results publications and other study-related documents

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