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Trial registered on ANZCTR


Registration number
ACTRN12622000728730
Ethics application status
Approved
Date submitted
5/05/2022
Date registered
20/05/2022
Date last updated
20/05/2022
Date data sharing statement initially provided
20/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Multilayer Silicone Dressings as Compared with Standard Care for Prevention of Sacral Pressure Injuries in Community Cancer Patients: A Cluster Randomised Control Trial
Scientific title
Multilayer Silicone Dressings as Compared with Standard Care for Prevention of Sacral Pressure Injuries in Community Cancer Patients: A Cluster Randomised Control Trial
Secondary ID [1] 307045 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injury 326189 0
Cancer 326190 0
Palliative care 326191 0
Condition category
Condition code
Skin 323494 323494 0 0
Other skin conditions
Cancer 323583 323583 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pragmatic, open-label, three-arm cluster randomised control (CRCT) study will be conducted in a community hospice population.
When a patient becomes eligible for recruitment to one of the intervention arms, the patient’s primary nurse will provide the patient with a study Information Sheet in accordance with the cluster random allocation. If the patient agrees to participate, the principal researcher will be informed and will visit to obtain written consent for participation and recruit the patient. The patients randomised to either prophylactic multilayer silicon dressing intervention arm will have a skin inspection and assessment completed. A wound care plan will be instigated specifying the selected multilayer silicone dressing and the applicable dressing applied. Subsequent dressing changes will be completed by the usual hospice nurse during the patients’ scheduled visits.
Intervention dressing number one (Brand 1) has demonstrated efficacy in reducing PI incidence in ICU and residential aged care settings and will provide comparability for the hospice population.
Intervention dressing number two (Brand 2) is the current standard dressing used within the community organisation and offers a pragmatic choice of sacral dressing for comparison purposes which has evidence for pressure injury prevention.
Both are five-layer silicone dressings similar in structure but each company has their claimed specific patents within the materials.
All patients in the study will receive standard care.
Arm 1: In addition to the standard care, patients randomised to intervention arm 1: will have a prophylactic multilayer silicone dressing (Brand 1) size 16 x 20 or 22 x 24cm as appropriate applied to the sacrum. The sacral dressing will be changed three times a week during the usual hospice nurse visit as scheduled for at-risk hospice care patients or sooner if the dressing becomes dislodged and will take approximately 5 minutes to apply.
Arm 2: In addition to standard care, patients randomised to intervention arm 2: will have a prophylactic multilayer silicone dressing (Brand 2) 17.2 x 17.5cm or 21.6 x 23cm as appropriate applied to the sacrum. The sacral dressing will be changed three times a week at the usual hospice nurse visit schedule for at-risk hospice care clients or sooner if the dressing becomes dislodged and will take approximately 5 minutes to apply.

Data will be collected for 4 weeks or sooner should the patient: decease, develop a pressure injury, transfer to a hospital-based or other service or withdraw for any reason.
The health organisation uses an electronic wound record for all assessments, care plans and treatments for the wound admitted to their service. This includes time taken to complete the wound care.
Data collection will be from this electronic system which the nurses use as part of usual business. No extra data collection methods are required for analysis of this study. This electronic system is reported on daily as part of usual business for the organisation.
Intervention code [1] 323515 0
Prevention
Comparator / control treatment
If a patient is randomised to the control arm, they will be monitored for the development of a pressure injury with standard care. Nursing visits for at risk patients are scheduled routinely three times a week or sooner should the patients’ needs require. Skin assessment and education is provided at each nursing visit as standard practice.
Standard care is the recommended pressure injury prevention strategies (PIPS) implemented to standardise the care across the health service . The PIPS recommendations outlined in the Prevention and treatment of pressure ulcers/injuries: Clinical practice guideline: The international guideline (EPUAP, NPIAP & PPPIA., 2019) inform standard care. These include: risk assessment, skin inspection and the implementation of appropriate support surfaces (bed and chair seating devices) and repositioning equipment (hoist or slide sheet). It also involves the provision of patient and caregiver/family pressure injury prevention education, including equipment use and maintenance, the need for regular repositioning, skincare and advice to optimise nutrition for the hospice patient. The organisation currently has pressure injury prevention brochures in use and provided to all patients. The health organisation provides support surfaces and equipment and regular maintenance at no cost to the patient.
Control group
Active

Outcomes
Primary outcome [1] 331264 0
The incidence and severity of sacral pressure injuries as assessed the European Pressure Ulcer Advisory Panel & National Pressure Injury Advisory Panel staging classification as a composite primary outcome.
Timepoint [1] 331264 0
Monitored for development at each nursing visit. for 4 weeks or sooner should the patient: decease, develop an adverse event , transfer to a hospital-based or other service, or withdraw for any reason.
Primary outcome [2] 331265 0
Cost of using prophylactic multilayer silicone dressings as part of a prevention plan. Costing will include all wound treatment consumables and nursing time for visits and application of prophylactic dressings collected in the health organisations' electronic wound care record
Timepoint [2] 331265 0
Collected at each patient visit for 4 weeks or sooner should the patient: decease, develop a pressure injury or other adverse event , transfer to a hospital-based or other service, or withdraw for any reason.
Secondary outcome [1] 409360 0
Palliative Care Outcome Collaboration (PCOC) Tools:
a) Resource Utilisation Groups—Activities of Daily Living
Timepoint [1] 409360 0
Collected at each patient visit for 4 weeks or sooner should the patient: decease, develop a pressure injury or other adverse event , transfer to a hospital-based or other service, or withdraw for any reason.
Secondary outcome [2] 409567 0
Palliative Care Outcome Collaboration (PCOC) Tools:
b) Karnofsky Score
Timepoint [2] 409567 0
Collected at each patient visit for 4 weeks or sooner should the patient: decease, develop a pressure injury or other adverse event , transfer to a hospital-based or other service, or withdraw for any reason.
Secondary outcome [3] 409568 0
Palliative Care Outcome Collaboration (PCOC) Tools:
c) Palliative Problem Care Severity Score
Timepoint [3] 409568 0
Collected at each patient visit for 4 weeks or sooner should the patient: decease, develop a pressure injury or other adverse event , transfer to a hospital-based or other service, or withdraw for any reason.
Secondary outcome [4] 409569 0
Palliative Care Outcome Collaboration (PCOC) Tools:
d) Symptom Assessment Scales
Timepoint [4] 409569 0
Collected at each patient visit for 4 weeks or sooner should the patient: decease, develop a pressure injury or other adverse event , transfer to a hospital-based or other service, or withdraw for any reason.
Secondary outcome [5] 409570 0
Palliative Care Outcome Collaboration (PCOC) Tools:
e) Palliative Care Phase
Timepoint [5] 409570 0
Collected at each patient visit for 4 weeks or sooner should the patient: decease, develop a pressure injury or other adverse event , transfer to a hospital-based or other service, or withdraw for any reason.

Eligibility
Key inclusion criteria
• A primary diagnosis of a cancer
• Over 18 years of age
• Resource Utilisation Groups—Activities of Daily Living (RUG-ADL) score greater than or equal to 3
• Able to provide written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The primary diagnosis is a non-malignant condition requiring palliative/hospice care
• Pre-existing Pressure Injury to the sacrum
• Sacral wounds of other aetiologies
• Declined or unable to provide written consent

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clustering groups of individuals into intervention or control helps evaluate the open-label non-pharmaceutical interventions in randomised studies more efficiently. This study will stratify clusters using geographical locations. The health organisation has three service centres located in the north, east and south metropolitan area. Three nursing teams are located in each service centre and consist of a nurse coordinator and four registered nurses who are allocated specific suburbs to manage. Cluster randomisation will occur within each of the three service centres and within the three nursing teams, providing nine groups or clusters across the health organisation. A computer-generated randomised allocation of the interventions and control arms to each nursing teams within each service centre will be undertaken to ensure equal numbers of patients within each cluster and across the geographical regions. Allocation will occur prior to the recruitment. As a patient enters the palliative service they are allocated to the team assigned in the area they live to manage their care and will be recruited to the intervention or control arm the managing nursing team is allocated to .
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The organisation’s pressure injury incidence data from 2019 for the hospice patients was between 11 to 24% across the service centres. Identified in the literature for similar studies was an absolute risk reduction (ARR) of 9% with a hazard ratio of 0.19 which was used to calculate a sample size for a three-arm cluster RCT, randomising individuals into treatment or control. Parameters used by the consulting statistician were power at 0.8, alpha at 0.05, probability of failure in the control group at 11% (low end of incidence in our population), probability of failure in the treatment group at 2% (absolute risk reduction of 9%), and hazard ratio of 0.19. Incidence data was available for the proposed experiment, and indicated a range of between 8 to 26% across teams which is consistent the literature. In addition, data by teams (3 per service centre) and within each service centre (3 sites) were available, allowing the calculation of cluster coefficients for power analysis given as an estimate of about 0.02 – 0.03.

An intention to treat analysis will be employed to preserve the randomisation process and account for all participants recruited. Pressure injury staging will employ a semi-parametric mixed-effects ordinal logistic regression model, and the three arms of the study will be treated as fixed effects. Mixed-effects Cox proportional hazards regressions will use time to presence of the PI as the dependent variable and incorporate cluster-specific random effects. The cluster-level summary analyses will compare the proportions using unpaired t-tests. Descriptive statistical analysis will determine the cost of preventing and treating PIs to 4-weeks or discharge.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
378
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311356 0
Other
Name [1] 311356 0
Silver Chain Group
Country [1] 311356 0
Australia
Primary sponsor type
Other
Name
Silver Chain Group
Address
6 Sundercombe Street, Osborne Park, WA, 6017
Country
Australia
Secondary sponsor category [1] 312742 0
None
Name [1] 312742 0
Address [1] 312742 0
Country [1] 312742 0
Other collaborator category [1] 282287 0
University
Name [1] 282287 0
Curtin University
Address [1] 282287 0
Kent Street, Bentley, WA, 6102
Country [1] 282287 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310848 0
Curtin University HREC
Ethics committee address [1] 310848 0
Kent Street, Bentley, WA, 6102
Ethics committee country [1] 310848 0
Australia
Date submitted for ethics approval [1] 310848 0
25/11/2021
Approval date [1] 310848 0
24/01/2022
Ethics approval number [1] 310848 0
HRE2022-0034

Summary
Brief summary
Pressure injuries, also commonly known as pressure ulcers or bedsores, are wounds considered adverse events when acquired in care. Pressure injuries are a burden to patients and their carers, due to pain and distress and can decrease the quality of life. This study aims to determine the usefulness and cost-efficiency of two different silicone dressings compared to usual care for the prevention of pressure injuries in cancer patients who are in palliative care.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have a primary diagnosis of any cancer, and you score three or over on the Resource Utilisation Groups – Activities of Daily Living (RUG-ADL) questionnaire.

Study details
All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. All three groups will receive standard care for the prevention of pressure injuries, which includes risk assessment, skin inspection and the implementation of appropriate support surfaces (bed and chair seating devices) and repositioning equipment (hoist or slide sheet). It also involves the provision of patient and caregiver/family prevention education, including equipment use and maintenance, the need for regular repositioning, skincare and advice to optimise nutrition for the hospice patient.
Participants allocated to group 1 will also have multilayer silicone dressing Brand 1 applied to the sacrum (lower back near buttocks). The dressing will be changed three times a week during the usual nurse visit schedule for at-risk palliative care patients or sooner if the dressing becomes dislodged.
Participants allocated to group 2 will also have multilayer silicone dressing Brand 2 applied to the sacrum (lower back near buttocks). The dressing will be changed three times a week during the usual nurse visit schedule for at-risk palliative care patients or sooner if the dressing becomes dislodged.
Participants allocated to group 3 will not receive any additional dressings and will be managed via standard care practices only. All participants will receive this care for up to 4 weeks following enrolment, unless they deteriorate, develop a pressure injury or need to be transferred to a hospital or other care facility.

It is hoped this research will determine whether the use of silicone dressings is practical and has any impact on the prevention of pressure injuries compared to usual care practices. If the silicone dressings are more effective than usual care, they may be implemented across other care facilities to improve the quality of life for future cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119082 0
Mrs Gordana Petkovska
Address 119082 0
Silver Chain Group
6 Sundercombe Street, Osborne Park, WA, 6017
Country 119082 0
Australia
Phone 119082 0
+61 410222101
Fax 119082 0
Email 119082 0
Gordana.Petkovska@silverchain.org.au
Contact person for public queries
Name 119083 0
Mrs Gordana Petkovska
Address 119083 0
Silver Chain Group
6 Sundercombe Street, Osborne Park, WA, 6017
Country 119083 0
Australia
Phone 119083 0
+61 410222101
Fax 119083 0
Email 119083 0
Gordana.Petkovska@silverchain.org.au
Contact person for scientific queries
Name 119084 0
Mrs Gordana Petkovska
Address 119084 0
Silver Chain Group
6 Sundercombe Street, Osborne Park, WA, 6017
Country 119084 0
Australia
Phone 119084 0
+61 410222101
Fax 119084 0
Email 119084 0
Gordana.Petkovska@silverchain.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.