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Trial registered on ANZCTR


Registration number
ACTRN12618000319279
Ethics application status
Approved
Date submitted
27/02/2018
Date registered
5/03/2018
Date last updated
5/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness of pressure mattresses for people over 65 years residing in the community
Scientific title
Comparison of active and reactive pressure mattresses in the treatment of Stage 2 pressure injuries for people over 65 years residing in the community
Secondary ID [1] 294169 0
Nil known
Universal Trial Number (UTN)
U1111-1209-9387
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage 2 pressure injury 306800 0
Condition category
Condition code
Injuries and Accidents 305906 305906 0 0
Other injuries and accidents
Skin 305942 305942 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a reactive pressure mattress chosen from a range of mattresses:
- ROHO overlay (3x ROHO sections and 1x foam section)
- Curocell AreaZone mattress replacement
- Curocell SAM mattress overlay
- Softform Premier mattress replacement
- Pressureguard CFT mattress replacement
- BetterLiving Triple layer mattress replacement

Participants will be provided mattresses from this list based primarily on the type of bed the mattress will be used on eg if being used on a bed shared with someone else or a double bed then they will be allocated an overlay but if they are being used on a single bed that can use a mattress replacement then one of these will be allocated. After this it will be based on the availability of the mattresses the stock for the study.

Other mattresses may be added to this list however all mattresses need to meet the definition of reactive mattress as per the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline"" (NPUAP, EPUAP & PPPPIA, 2014). Mattresses with dual functionality will be excluded.

Mattresses are to be used based on the participants' normal bed patterns.

All participants, regardless of allocation will be provided with:
- face-to-face wound care by community nurses (either in their homes or in the ambulatory clinic as per standard practice). These community nurses complete this type of wound care as part of their core business. Wound care frequency will vary depending on the severity and healing of the wound, based on current clinical practice.
- pressure injury education provided by the research team (either in the home or in the ambulatory clinic as per standard practice), occupational therapists with over 10 years experience. This will occur once immediately prior to mattress provision.
- provision of a high profile ROHO cushion for use when sitting out of bed
- occupational therapy assessment, completed by the research team (either in the home or in the ambulatory clinic as per standard practice), occupational therapists with over 10 years experience. This will occur once immediately prior to mattress provision.

Interventions will be provided on an individual basis. Participants will remain using the provided mattress and cushion for two weeks following the healing of the Stage 2 pressure injury to a maximum of 8 weeks.
Intervention code [1] 300458 0
Treatment: Devices
Intervention code [2] 300459 0
Prevention
Comparator / control treatment
Provision of an active pressure mattress chosen from a range of mattresses:
- Curocell Uno mattress replacement
- Viruoso mattress replacement
- Salsbury mattress overlay
- Premium Digital 9 mattress replacement
- Premium Digital 5 mattress overlay

Participants will be provided mattresses from this list based primarily on the type of bed the mattress will be used on eg if being used on a bed shared with someone else or a double bed then they will be allocated an overlay but if they are being used on a single bed that can use a mattress replacement then one of these will be allocated. After this it will be based on the availability of the mattresses the stock for the study.

Other mattresses may be added to this list however all mattresses need to meet the definition of active mattress as per the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline"" (NPUAP, EPUAP & PPPPIA, 2014). Mattresses with dual functionality will be excluded.

Mattresses are to be used based on the participants' normal bed patterns.

All participants, regardless of allocation will be provided with:
- face-to-face wound care by community nurses (either in their homes or in the ambulatory clinic as per standard practice). These community nurses complete this type of wound care as part of their core business. Wound care frequency will vary depending on the severity and healing of the wound, based on current clinical practice.
- pressure injury education provided by the research team (either in the home or in the ambulatory clinic as per standard practice), occupational therapists with over 10 years experience. This will occur once immediately prior to mattress provision.
- provision of a high profile ROHO cushion for use when sitting out of bed
- occupational therapy assessment, completed by the research team (either in the home or in the ambulatory clinic as per standard practice), occupational therapists with over 10 years experience. This will occur once immediately prior to mattress provision.

Interventions will be provided on an individual basis. Participants will remain using the provided mattress and cushion for two weeks following the healing of the Stage 2 pressure injury to a maximum of 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 304945 0
Time to complete healing of the primary pressure injury as determined by the Revised Photographic Wound Assessment Tool (RevPWAT). A wound will be considered healed when it has a score of 0 for sub-sections 1-7 and a score of <2 for sub-section 8.
Timepoint [1] 304945 0
Photographs for the RevPWAT will be completed at every wound care session.
Timepoints will be:
- baseline (at provision of mattress)
- weekly
- at complete wound healing (primary timepoint)
Primary outcome [2] 304946 0
Where complete healing does not occur within 8 weeks, rate of healing will be used as determined by changes in RevPWAT points over time (RevPWAT baseline score - RevPWAT 8 week score)/8 (no of weeks in study).
Timepoint [2] 304946 0
Photographs for the RevPWAT will be completed at every wound care session.
Timepoints will be:
- baseline (at provision of mattress)
- weekly
- at 8 weeks from provision of mattress (primary timepoint)
Secondary outcome [1] 343679 0
User acceptability of the provided mattress as determined by a survey designed specifically for this study, investigating subjective factors regarding thoughts and perceptions about the use of the mattress.
Timepoint [1] 343679 0
Survey provided at baseline (provision of mattress) for information relating to current mattress and thoughts/perceptions. second survey provided 10-14 days after provision of mattress to capture experiences and individual subjective comparison.
Secondary outcome [2] 343808 0
Changes in sleeping habits as determined by a survey designed specifically for this study.
Timepoint [2] 343808 0
This survey will be completed at baseline (provision of mattress) for information relating to current sleeping habits and 10-14 days after mattress provision to capture experiences and changes in habits.
Secondary outcome [3] 343809 0
Changes in pain levels as determined by a 10-point pain scale and subjective comments from a survey designed specifically for this study.
Timepoint [3] 343809 0
This survey will be completed at baseline (provision of mattress) for information relating to current pain level and 10-14 days after mattress provision to capture experiences and changes in pain.

Eligibility
Key inclusion criteria
1/ aged 65 years or older
2/ residing in a community setting ie in a private home
3/ existing Stage 2 pressure injury - any location or aetiology
4/ have a bed that is appropriate for the support surfaces
5/ inability to re-position off the pressure injury
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1/ existing Stage 3, Stage 4, Suspected Deep Tissue Injury or Unstageable pressure injury
2/ Participation in the study during a previous episode of care.

CONSIDERED FOR INCLUSION:
Participants with a Stage 1 pressure injury will be considered for eligibility if they also have a Stage 2 pressure injury, with the Stage 2 pressure injury being considered the primary pressure injury for the purposes of the study. If participants only have a Stage 1 pressure injury then they will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be allocated to groups by an online random number generator between 1 and 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
SAMPLE SIZE:
Power calculations were not able to be completed due to unavailable data regarding standard deviations in previous literature. A priori sample was determined for a total sample of n=80 to aim for a minimum final total sample of n=60 (n=30 for each group, utilising the central limit theorem) after allowing for withdrawals. Power calculations, including Cohen's d for effect size, will need to be completed following the data collection phase.

STATISTICAL ANALYSIS:
Due to the non-inferiority design of the study, data analysis will be completed twice and compared: once as a Per Protocol analysis and once as an Intention to Treat analysis.
Provided assumptions are met the following statistical tests will be completed:
- Comparing wound healing times -> Independent t-test (average healing time reactive surfaces vs average healing time active surfaces)
- Comparing number of new pressure injuries developed -> Independent t-test (total number of new pressure injuries reactive surfaces vs total number of new pressure injuries active surfaces)
- Comparing number of pressure injuries not healed at 8 weeks -> Independent t-test (number of pressure injuries not healed at 8 weeks for reactive surfaces vs active surfaces)
- Changes in Pain scores -> 2-way Mixed ANOVA (between group analysis to compare pre- and post-pain scores for each mattress type, independent group analysis to compare the mattress types)
- Changes in time spent in bed -> 2-way Mixed ANOVA (between group analysis to compare pre- and post-time for each mattress type, independent group analysis to compare the mattress types)
- Changes in frequency of repositioning -> 2-way Mixed ANOVA (between group analysis to compare pre- and post-frequencies for each mattress type, independent group analysis to compare the mattress types)

If the assumptions cannot be met, despite data transformation, then the relevant non-parametric tests will be completed.

Recruitment
Recruitment status
Not yet recruiting
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)
ACT
Recruitment postcode(s) [1] 21759 0
2600 - Barton
Recruitment postcode(s) [2] 21760 0
2600 - Canberra
Recruitment postcode(s) [3] 21762 0
2600 - Deakin
Recruitment postcode(s) [4] 21763 0
2600 - Deakin West
Recruitment postcode(s) [5] 21766 0
2600 - Parkes
Recruitment postcode(s) [6] 21767 0
2600 - Russell
Recruitment postcode(s) [7] 21769 0
2600 - Yarralumla
Recruitment postcode(s) [8] 21770 0
2601 - Acton
Recruitment postcode(s) [9] 21771 0
2601 - Canberra
Recruitment postcode(s) [10] 21772 0
2601 - City
Recruitment postcode(s) [11] 21773 0
2602 - Ainslie
Recruitment postcode(s) [12] 21774 0
2602 - Dickson
Recruitment postcode(s) [13] 21775 0
2602 - Downer
Recruitment postcode(s) [14] 21776 0
2602 - Hackett
Recruitment postcode(s) [15] 21777 0
2602 - Lyneham
Recruitment postcode(s) [16] 21778 0
2602 - O'connor
Recruitment postcode(s) [17] 21779 0
2602 - Watson
Recruitment postcode(s) [18] 21780 0
2603 - Forrest
Recruitment postcode(s) [19] 21781 0
2603 - Griffith
Recruitment postcode(s) [20] 21782 0
2603 - Manuka
Recruitment postcode(s) [21] 21783 0
2603 - Red Hill
Recruitment postcode(s) [22] 21784 0
2604 - Kingston
Recruitment postcode(s) [23] 21785 0
2604 - Narrabundah
Recruitment postcode(s) [24] 21786 0
2605 - Curtin
Recruitment postcode(s) [25] 21787 0
2605 - Garran
Recruitment postcode(s) [26] 21788 0
2605 - Hughes
Recruitment postcode(s) [27] 21789 0
2606 - Chifley
Recruitment postcode(s) [28] 21790 0
2606 - Lyons
Recruitment postcode(s) [29] 21791 0
2606 - O'malley
Recruitment postcode(s) [30] 21792 0
2606 - Phillip
Recruitment postcode(s) [31] 21793 0
2606 - Swinger Hill
Recruitment postcode(s) [32] 21794 0
2606 - Woden
Recruitment postcode(s) [33] 21795 0
2607 - Farrer
Recruitment postcode(s) [34] 21796 0
2607 - Isaacs
Recruitment postcode(s) [35] 21797 0
2607 - Mawson
Recruitment postcode(s) [36] 21798 0
2607 - Pearce
Recruitment postcode(s) [37] 21799 0
2607 - Torrens
Recruitment postcode(s) [38] 21800 0
2609 - Fyshwick
Recruitment postcode(s) [39] 21801 0
2609 - Majura
Recruitment postcode(s) [40] 21802 0
2609 - Pialligo
Recruitment postcode(s) [41] 21803 0
2609 - Symonston
Recruitment postcode(s) [42] 21804 0
2611 - Bimberi
Recruitment postcode(s) [43] 21805 0
2611 - Brindabella
Recruitment postcode(s) [44] 21806 0
2611 - Chapman
Recruitment postcode(s) [45] 21808 0
2611 - Duffy
Recruitment postcode(s) [46] 21809 0
2611 - Uriarra
Recruitment postcode(s) [47] 21810 0
2611 - Fisher
Recruitment postcode(s) [48] 21811 0
2611 - Holder
Recruitment postcode(s) [49] 21812 0
2611 - Rivett
Recruitment postcode(s) [50] 21813 0
2611 - Stirling
Recruitment postcode(s) [51] 21814 0
2611 - Uriarra Village
Recruitment postcode(s) [52] 21815 0
2611 - Waramanga
Recruitment postcode(s) [53] 21816 0
2611 - Weston Creek
Recruitment postcode(s) [54] 21817 0
2611 - Wright
Recruitment postcode(s) [55] 21818 0
2612 - Braddon
Recruitment postcode(s) [56] 21819 0
2612 - Campbell
Recruitment postcode(s) [57] 21820 0
2612 - Reid
Recruitment postcode(s) [58] 21821 0
2612 - Turner
Recruitment postcode(s) [59] 21822 0
2614 - Aranda
Recruitment postcode(s) [60] 21823 0
2614 - Cook
Recruitment postcode(s) [61] 21824 0
2614 - Hawker
Recruitment postcode(s) [62] 21825 0
2614 - Macquarie
Recruitment postcode(s) [63] 21826 0
2614 - Page
Recruitment postcode(s) [64] 21827 0
2614 - Scullin
Recruitment postcode(s) [65] 21828 0
2614 - Weetangera
Recruitment postcode(s) [66] 21829 0
2616 - Belconnen
Recruitment postcode(s) [67] 21830 0
2615 - Charnwood
Recruitment postcode(s) [68] 21831 0
2615 - Dunlop
Recruitment postcode(s) [69] 21832 0
2615 - Florey
Recruitment postcode(s) [70] 21833 0
2615 - Flynn
Recruitment postcode(s) [71] 21834 0
2615 - Fraser
Recruitment postcode(s) [72] 21835 0
2615 - Higgins
Recruitment postcode(s) [73] 21836 0
2615 - Holt
Recruitment postcode(s) [74] 21837 0
2615 - Kippax
Recruitment postcode(s) [75] 21838 0
2615 - Latham
Recruitment postcode(s) [76] 21839 0
2615 - Macgregor
Recruitment postcode(s) [77] 21840 0
2615 - Melba
Recruitment postcode(s) [78] 21841 0
2615 - Spence
Recruitment postcode(s) [79] 21842 0
2617 - Belconnen
Recruitment postcode(s) [80] 21843 0
2617 - Bruce
Recruitment postcode(s) [81] 21844 0
2617 - Evatt
Recruitment postcode(s) [82] 21845 0
2617 - Giralang
Recruitment postcode(s) [83] 21846 0
2617 - Kaleen
Recruitment postcode(s) [84] 21847 0
2617 - Lawson
Recruitment postcode(s) [85] 21848 0
2617 - Mckellar
Recruitment postcode(s) [86] 21849 0
2617 - University Of Canberra
Recruitment postcode(s) [87] 21850 0
2618 - Hall
Recruitment postcode(s) [88] 21851 0
2900 - Greenway
Recruitment postcode(s) [89] 21852 0
2900 - Tuggeranong
Recruitment postcode(s) [90] 21853 0
2902 - Kambah
Recruitment postcode(s) [91] 21854 0
2903 - Oxley
Recruitment postcode(s) [92] 21855 0
2903 - Wanniassa
Recruitment postcode(s) [93] 21856 0
2904 - Fadden
Recruitment postcode(s) [94] 21857 0
2904 - Gowrie
Recruitment postcode(s) [95] 21858 0
2904 - Macarthur
Recruitment postcode(s) [96] 21859 0
2904 - Monash
Recruitment postcode(s) [97] 21860 0
2905 - Bonython
Recruitment postcode(s) [98] 21861 0
2905 - Calwell
Recruitment postcode(s) [99] 21862 0
2905 - Chisholm
Recruitment postcode(s) [100] 21863 0
2905 - Gilmore
Recruitment postcode(s) [101] 21866 0
2905 - Theodore
Recruitment postcode(s) [102] 21867 0
2906 - Banks
Recruitment postcode(s) [103] 21868 0
2906 - Conder
Recruitment postcode(s) [104] 21869 0
2906 - Gordon
Recruitment postcode(s) [105] 21870 0
2911 - Crace
Recruitment postcode(s) [106] 21871 0
2911 - Mitchell
Recruitment postcode(s) [107] 21872 0
2913 - Casey
Recruitment postcode(s) [108] 21873 0
2913 - Franklin
Recruitment postcode(s) [109] 21874 0
2913 - Kinlyside
Recruitment postcode(s) [110] 21875 0
2913 - Ngunnawal
Recruitment postcode(s) [111] 21876 0
2913 - Nicholls
Recruitment postcode(s) [112] 21877 0
2913 - Palmerston
Recruitment postcode(s) [113] 21878 0
2913 - Taylor
Recruitment postcode(s) [114] 21879 0
2914 - Amaroo
Recruitment postcode(s) [115] 21880 0
2914 - Bonner
Recruitment postcode(s) [116] 21881 0
2914 - Forde
Recruitment postcode(s) [117] 21882 0
2914 - Harrison
Recruitment postcode(s) [118] 21883 0
2914 - Moncrieff
Recruitment postcode(s) [119] 21884 0
2620 - Tharwa
Recruitment postcode(s) [120] 21885 0
2620 - Hume
Recruitment postcode(s) [121] 21886 0
2620 - Oaks Estate

Funding & Sponsors
Funding source category [1] 298804 0
University
Name [1] 298804 0
University of Canberra - Faculty of Health
Address [1] 298804 0
Faculty of Health
University of Canberra
University Dr
Bruce ACT 2617
Country [1] 298804 0
Australia
Funding source category [2] 298808 0
Hospital
Name [2] 298808 0
ACT Health
Address [2] 298808 0
ACT Health - Community Care Program
Phillip Health Centre
Corinna St
Woden ACT 2606
Country [2] 298808 0
Australia
Primary sponsor type
Individual
Name
Katherine Rae
Address
PhD Candidate - Faculty of Health
University of Canberra
University Dr
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 297995 0
Individual
Name [1] 297995 0
Judith Barker
Address [1] 297995 0
Wound Care Nurse Practitioner
ACT Health - Community Care Program
Phillip Health Centre
Corinna St
Woden ACT 2606
Country [1] 297995 0
Australia
Secondary sponsor category [2] 297999 0
Individual
Name [2] 297999 0
Asst Prof Stephen Isbel
Address [2] 297999 0
Faculty of Health
University of Canberra
University Dr
Bruce ACT 2617
Country [2] 297999 0
Australia
Other collaborator category [1] 279963 0
Commercial sector/Industry
Name [1] 279963 0
Astris Lifecare
Address [1] 279963 0
Astris Lifecare - contact Gavin Little
5 Millenium Ct
Silverwater NSW 2128
Country [1] 279963 0
Australia
Other collaborator category [2] 279964 0
Commercial sector/Industry
Name [2] 279964 0
Total Mobility
Address [2] 279964 0
Total Mobility - contact Tim Kapustin
3/21 Raws Cres
Hume ACT 2620
Country [2] 279964 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299750 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 299750 0
ACT Health - Canberra Hospital Campus
PO Box 11
Woden ACT 2606
Ethics committee country [1] 299750 0
Australia
Date submitted for ethics approval [1] 299750 0
11/10/2017
Approval date [1] 299750 0
09/02/2018
Ethics approval number [1] 299750 0
ETH.10.17.233
Ethics committee name [2] 299754 0
University of Canberra
Ethics committee address [2] 299754 0
University of Canberra
Univeristy Dr
Bruce ACT 2617
Ethics committee country [2] 299754 0
Australia
Date submitted for ethics approval [2] 299754 0
Approval date [2] 299754 0
16/02/2018
Ethics approval number [2] 299754 0
20180161

Summary
Brief summary
The aim of this study is to compare how effective different types of specialised mattresses are at healing pressure injuries. We are investigating if one type mattress helps these kinds of wounds heal faster than the other type of mattress.

This study has been based on current practice within ACT Health Community Care services for management of this kind of injury. Participation in the study will include:
- allocation of a pressure mattress, either an active or reactive mattress
- provision of a pressure cushion for use when not resting in bed
- standard wound care provided by the Community Care Nurses, including photographs of the wounds, which will be assessed for healing
- occupational therapy assessment, including pressure injury prevention education
- completion of two online surveys

Participants will be part of the study for up to 8 weeks.
Trial website
Trial related presentations / publications
Public notes
Attachments [2] 2456 2456 0 0
http://www.anzctr.org.au/AnzctrAttachments/374599-Consent Form.pdf (Participant information/consent)
Attachments [3] 2457 2457 0 0
Attachments [4] 2458 2458 0 0
Attachments [5] 2459 2459 0 0

Contacts
Principal investigator
Name 81454 0
Mrs Katherine E Rae
Address 81454 0
Occupational Therapist, ACT Health Directorate: Canberra, Australian
PhD Candidate, University of Canberra; Canberra, Australia

Phillip Health Centre,
Keltie St,
Woden, ACT, 2606
Country 81454 0
Australia
Phone 81454 0
+61 2 6205 1487
Fax 81454 0
Email 81454 0
katherine.rae@act.gov.au
Contact person for public queries
Name 81455 0
Mrs Katherine Rae
Address 81455 0
Occupational Therapist, ACT Health Directorate: Canberra, Australian
PhD Candidate, University of Canberra; Canberra, Australia

Phillip Health Centre,
Keltie St,
Woden, ACT, 2606
Country 81455 0
Australia
Phone 81455 0
+61 2 6205 1487
Fax 81455 0
Email 81455 0
katherine.rae@act.gov.au
Contact person for scientific queries
Name 81456 0
Mrs Katherine E Rae
Address 81456 0
Occupational Therapist, ACT Health Directorate: Canberra, Australian
PhD Candidate, University of Canberra; Canberra, Australia

Phillip Health Centre,
Keltie St,
Woden, ACT, 2606
Country 81456 0
Australia
Phone 81456 0
+61 2 6205 1487
Fax 81456 0
Email 81456 0
katherine.rae@canberra.edu.au

No information has been provided regarding IPD availability
Summary results
No Results