None listed
Conditions
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.
Interventions
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 the intervention arm in accordance with the care team's cluster random allocation, the patient's primary nurse will provide the patient with a study Participant Information Sheet and multilayer silicone dressing product information brochure. Once a patient has indicated their willingness to participate in the study, t
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 the intervention arm in accordance with the care team's cluster random allocation, the patient's primary nurse will provide the patient with a study Participant Information Sheet and multilayer silicone dressing product information brochure. Once a patient has indicated their willingness to participate in the study, the principal researcher will be informed by the primary nurse and will contact the patient to organise a visit to obtain consent for participation and complete the skin inspection. The applicable prophylactic MLSD will be applied, and a care plan will be instigated. However, as patients will be recruited towards the end-of-life care, if they prefer their primary nurse will be able to obtain consent, complete a skin inspection and apply the randomised prophylactic MLSD, the research nurse will be informed of the recruitment. This was approved by HREC and implemented prior to the commencement of data collection. The primary nurse will send a patient linked message through the organisation’s electronic communication platform to the research nurse who will then review the electronic medical record and collect the study data 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.
Sponsors
Silver Chain Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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 verbal consent
Outcome results
None listed