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Trial registered on ANZCTR


Registration number
ACTRN12615000317594
Ethics application status
Approved
Date submitted
23/03/2015
Date registered
8/04/2015
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Date results information initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study: Evaluation of a silicone gel adhesive hydrocellular foam dressing for the prevention of sacral pressure injuries in hospitalised elderly patients
Scientific title
Evaluation of a silicone gel adhesive hydrocellular foam dressing in comparison to standard care for the use in sacral pressure injuries in hospitalised elderly patients'

Secondary ID [1] 286283 0
Nil Known
Universal Trial Number (UTN)
U1111-1167-7188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injury 294356 0
Pressure ulcer/decubitus ulcer 294638 0
Bedsores 294639 0
Condition category
Condition code
Skin 294676 294676 0 0
Other skin conditions
Skin 294937 294937 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group patients will have the Allevyn Life Sacrum foam dressing applied to their sacrum for a maximum of 4 weeks. These dressings will be lifted and the skin beneath inspected daily by nursing staff, then the same dressing will be reapplied, unless the integrity of the dressing is compromised in which case it will be replaced. A new dressing will be applied in all cases, after 7 days in situ. Dressing changes will be monitored daily and recorded on a standardised data collection form.
Intervention code [1] 291308 0
Treatment: Devices
Intervention code [2] 291538 0
Prevention
Comparator / control treatment
All patients will receive standard pressure injury prevention strategies from the multidisciplinary hospital team, which includes (but are not limited to) ongoing risk assessment, regular repositioning (self encouraged or staff assist) and skin care. As well as appropriate pressure redistribution devices based on patient needs and risk. patients will be monitored by nursing staff for a duration of 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294426 0
The proportion of patients who develop sacral pressure injury, as assessed by diagnosis of specialist wound care nurses.
Timepoint [1] 294426 0
Baseline data will be collected on recruitment to the study. This will then be followed up with daily assessments by the ward research nurses until participants are discharged from the unit (or up to a maximum of 4 weeks). data will be recorded on standardised data collection forms
Secondary outcome [1] 313283 0
Dressing comfort from the patient’s perspective
Timepoint [1] 313283 0
Baseline data will be collected on recruitment to the study. This will then be followed up with daily assessments by the ward research nurses until participants are discharged from the unit (or up to a maximum of 4 weeks). Data will be collected by a 5 point likert scale, assessing patient comfort for: new dressing/dressing inspection, sleeping, sitting, mobilising and hygiene.
Secondary outcome [2] 313284 0
To evaluate dressing utility from the nurse’s perspective
Timepoint [2] 313284 0
Baseline data will be collected on recruitment to the study. This will then be followed up with daily assessments by the ward research nurses until participants are discharged from the unit (or up to a maximum of 4 weeks). Data will be collected using a likert type scale
Secondary outcome [3] 313285 0
To quantify the direct costs associated with use of the foam dressing.
Timepoint [3] 313285 0
Baseline data will be collected on recruitment to the study. This will then be followed up with daily assessments by the ward research nurses until participants are discharge from the unit (or up to a maximum of 4 weeks). Resources to be costed include: PI interventions (e.g. mattresses, dressings etc.); length of hospital stay; Treatment for PI where this occurs (e.g. dressings, medications, surgery etc.).

Eligibility
Key inclusion criteria
1) >/= 65 years of age.
2) Patients assessed to be at risk of pressure injury development i.e. Waterlow Score > 10.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Pre-existing sacral pressure injury.
2) Evidence of incontinence associated dermatitis (IAD).
3) Skin disease or trauma/skin damage to sacral region.
4) Documented allergy to adhesives.
5) Patients previously recruited to the study.

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 patients admitted to the Geriatric Evaluation and Management (GEM) unit will be screened by the research nurse to determine if they meet the inclusion criteria. Each potential participant will then be provided with an information letter explaining the study. Those who agree to participate will be required to provide written consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online random number generator will be used to allocate participants (1:1) to either the intervention or control group. Allocation will initially be concealed by using sealed opaque envelopes.
1) Intervention group: application of foam dressing.
2) Control group: standard care.



Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data were entered into SPSS Version 25 for analysis. Descriptive statistics were used to describe the sample and inferential statistics used to analyse differences and relationships in the data. Significance set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3528 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 9292 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 290842 0
Commercial sector/Industry
Name [1] 290842 0
Smith & Nephew Pty Limited
Address [1] 290842 0
Level 3, 225 Montague Road

West End
Queensland 4101
Australia
Country [1] 290842 0
Australia
Primary sponsor type
Hospital
Name
Nursing Research and Practice Development centre
Address
The Prince Charles Hospital
Rode Road
Chermside Queensland 4032
Country
Australia
Secondary sponsor category [1] 289579 0
University
Name [1] 289579 0
Australian Catholic University
Address [1] 289579 0
1100 Nudgee Road Banyo Queensland 4014

Postal: PO Box 456 Virginia Queensland 4014
Country [1] 289579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292463 0
Research, Ethics and Governance Unit
Ethics committee address [1] 292463 0
The Prince Charles Hospital
Rode Road
Chermside Queensland 4032
Ethics committee country [1] 292463 0
Australia
Date submitted for ethics approval [1] 292463 0
Approval date [1] 292463 0
12/12/2014
Ethics approval number [1] 292463 0
HREC/14/QPCH/256

Summary
Brief summary
The aim of this study is to gather information about the effectiveness of a foam dressing to prevent the development of sacral pressure injuries (PI). Currently, preventative dressings are not used routinely. In this study,of adult patients who are at high risk of developing a PI, half of the sample of 126 patients will be randomly allocated to receive the sacral foam dressing and half will receive standard care i.e. no sacral dressing. The dressing will remain in place for the duration of each participant's hospital stay. It will be replaced routinely after 7 days, or before if needed. In all patients, the sacral skin will be inspected on a daily basis to observe for the presence of PI, for a maximum period of 4 weeks. The main outcome measure will be the occurrence of sacral PI. Dressing comfort will be evaluated from the patient's perspective, and its utility will be evaluated by nurses. A cost analysis will also be undertaken.

It is anticipated that patients treated with the foam dressing will have a lower incidence of pressure injuries than those receiving standard care.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 55410 0
Prof Paul Fulbrook
Address 55410 0
Nursing Research and Practice Development Centre
The Prince Charles Hospital
Rode Road
Chermside Queensland 4032
Country 55410 0
Australia
Phone 55410 0
+61 7 3139 4087
Fax 55410 0
+61 7 3139 6017
Email 55410 0
paul.fulbrook@acu.edu.au
Contact person for public queries
Name 55411 0
Mr Damian Williams
Address 55411 0
The Prince Charles Hospital
Rode Road
Chermside Queensland 4032
Country 55411 0
Australia
Phone 55411 0
+61 7 3139 5646
Fax 55411 0
Email 55411 0
damian.williams@health.qld.gov.au
Contact person for scientific queries
Name 55412 0
Dr Roger Lord
Address 55412 0
Australian Catholic University
PO Box 456 Virginia Queensland 4014
Country 55412 0
Australia
Phone 55412 0
+61 7 3623 7240
Fax 55412 0
Email 55412 0
roger.lord@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality according to hospital ethics committee approval
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary