ANZCTR - Registration

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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

16/01/2023

Date data sharing statement initially provided

27/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Testing the effectiveness of pressure mattresses for people over 50 years residing in the community

Scientific title

Comparison of active and reactive pressure mattresses in the treatment of Stage 2, Unstageable pressure injuries and Suspected Deep Tissue Injuries for people over 50 years residing in the community

Secondary ID [1]

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

Unstageable Pressure Injuries

Suspected Deep Tissue Injuries

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Skin

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 (following list is not exhaustive):
- 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 air-floatation 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 pressure injury to a maximum of 8 weeks.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Prevention

Comparator / control treatment

Provision of an active pressure mattress chosen from a range of mattresses (following list is not exhaustive):
- 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 air-floatation 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 pressure injury to a maximum of 8 weeks.

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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]

Changes in sleeping habits as determined by a survey designed specifically for this study.

Timepoint [2]

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]

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]

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 50 years or older
2/ residing in a community setting ie in a private home
3/ existing Stage 2 pressure injury, Unstageable pressure injury of Suspected Deep Tissue 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

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1/ existing Stage 3,or Stage 4 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

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties
Other reasons/comments

Other reasons

Recruitment was impacted by Covid-19 and extended as a result. Participant confidence was impacted by being a vulnerable population and participation from the health providers was also impacted due to changes in workplace priorities. It was determined that the anticipated number would not be reached within the timeframes of the project, despite extensions so recruitment was ceased.

Date of first participant enrolment

Anticipated

12/03/2018

Actual

26/03/2018

Date of last participant enrolment

Anticipated

30/04/2022

Actual

28/04/2022

Date of last data collection

Anticipated

30/06/2022

Actual

24/05/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment postcode(s) [1]

2600 - Barton

Recruitment postcode(s) [2]

2600 - Canberra

Recruitment postcode(s) [3]

2600 - Deakin

Recruitment postcode(s) [4]

2600 - Deakin West

Recruitment postcode(s) [5]

2600 - Parkes

Recruitment postcode(s) [6]

2600 - Russell

Recruitment postcode(s) [7]

2600 - Yarralumla

Recruitment postcode(s) [8]

2601 - Acton

Recruitment postcode(s) [9]

2601 - Canberra

Recruitment postcode(s) [10]

2601 - City

Recruitment postcode(s) [11]

2602 - Ainslie

Recruitment postcode(s) [12]

2602 - Dickson

Recruitment postcode(s) [13]

2602 - Downer

Recruitment postcode(s) [14]

2602 - Hackett

Recruitment postcode(s) [15]

2602 - Lyneham

Recruitment postcode(s) [16]

2602 - O'connor

Recruitment postcode(s) [17]

2602 - Watson

Recruitment postcode(s) [18]

2603 - Forrest

Recruitment postcode(s) [19]

2603 - Griffith

Recruitment postcode(s) [20]

2603 - Manuka

Recruitment postcode(s) [21]

2603 - Red Hill

Recruitment postcode(s) [22]

2604 - Kingston

Recruitment postcode(s) [23]

2604 - Narrabundah

Recruitment postcode(s) [24]

2605 - Curtin

Recruitment postcode(s) [25]

2605 - Garran

Recruitment postcode(s) [26]

2605 - Hughes

Recruitment postcode(s) [27]

2606 - Chifley

Recruitment postcode(s) [28]

2606 - Lyons

Recruitment postcode(s) [29]

2606 - O'malley

Recruitment postcode(s) [30]

2606 - Phillip

Recruitment postcode(s) [31]

2606 - Swinger Hill

Recruitment postcode(s) [32]

2606 - Woden

Recruitment postcode(s) [33]

2607 - Farrer

Recruitment postcode(s) [34]

2607 - Isaacs

Recruitment postcode(s) [35]

2607 - Mawson

Recruitment postcode(s) [36]

2607 - Pearce

Recruitment postcode(s) [37]

2607 - Torrens

Recruitment postcode(s) [38]

2609 - Fyshwick

Recruitment postcode(s) [39]

2609 - Majura

Recruitment postcode(s) [40]

2609 - Pialligo

Recruitment postcode(s) [41]

2609 - Symonston

Recruitment postcode(s) [42]

2611 - Bimberi

Recruitment postcode(s) [43]

2611 - Brindabella

Recruitment postcode(s) [44]

2611 - Chapman

Recruitment postcode(s) [45]

2611 - Duffy

Recruitment postcode(s) [46]

2611 - Uriarra

Recruitment postcode(s) [47]

2611 - Fisher

Recruitment postcode(s) [48]

2611 - Holder

Recruitment postcode(s) [49]

2611 - Rivett

Recruitment postcode(s) [50]

2611 - Stirling

Recruitment postcode(s) [51]

2611 - Uriarra Village

Recruitment postcode(s) [52]

2611 - Waramanga

Recruitment postcode(s) [53]

2611 - Weston Creek

Recruitment postcode(s) [54]

2611 - Wright

Recruitment postcode(s) [55]

2612 - Braddon

Recruitment postcode(s) [56]

2612 - Campbell

Recruitment postcode(s) [57]

2612 - Reid

Recruitment postcode(s) [58]

2612 - Turner

Recruitment postcode(s) [59]

2614 - Aranda

Recruitment postcode(s) [60]

2614 - Cook

Recruitment postcode(s) [61]

2614 - Hawker

Recruitment postcode(s) [62]

2614 - Macquarie

Recruitment postcode(s) [63]

2614 - Page

Recruitment postcode(s) [64]

2614 - Scullin

Recruitment postcode(s) [65]

2614 - Weetangera

Recruitment postcode(s) [66]

2616 - Belconnen

Recruitment postcode(s) [67]

2615 - Charnwood

Recruitment postcode(s) [68]

2615 - Dunlop

Recruitment postcode(s) [69]

2615 - Florey

Recruitment postcode(s) [70]

2615 - Flynn

Recruitment postcode(s) [71]

2615 - Fraser

Recruitment postcode(s) [72]

2615 - Higgins

Recruitment postcode(s) [73]

2615 - Holt

Recruitment postcode(s) [74]

2615 - Kippax

Recruitment postcode(s) [75]

2615 - Latham

Recruitment postcode(s) [76]

2615 - Macgregor

Recruitment postcode(s) [77]

2615 - Melba

Recruitment postcode(s) [78]

2615 - Spence

Recruitment postcode(s) [79]

2617 - Belconnen

Recruitment postcode(s) [80]

2617 - Bruce

Recruitment postcode(s) [81]

2617 - Evatt

Recruitment postcode(s) [82]

2617 - Giralang

Recruitment postcode(s) [83]

2617 - Kaleen

Recruitment postcode(s) [84]

2617 - Lawson

Recruitment postcode(s) [85]

2617 - Mckellar

Recruitment postcode(s) [86]

2617 - University Of Canberra

Recruitment postcode(s) [87]

2618 - Hall

Recruitment postcode(s) [88]

2900 - Greenway

Recruitment postcode(s) [89]

2900 - Tuggeranong

Recruitment postcode(s) [90]

2902 - Kambah

Recruitment postcode(s) [91]

2903 - Oxley

Recruitment postcode(s) [92]

2903 - Wanniassa

Recruitment postcode(s) [93]

2904 - Fadden

Recruitment postcode(s) [94]

2904 - Gowrie

Recruitment postcode(s) [95]

2904 - Macarthur

Recruitment postcode(s) [96]

2904 - Monash

Recruitment postcode(s) [97]

2905 - Bonython

Recruitment postcode(s) [98]

2905 - Calwell

Recruitment postcode(s) [99]

2905 - Chisholm

Recruitment postcode(s) [100]

2905 - Gilmore

Recruitment postcode(s) [101]

2905 - Theodore

Recruitment postcode(s) [102]

2906 - Banks

Recruitment postcode(s) [103]

2906 - Conder

Recruitment postcode(s) [104]

2906 - Gordon

Recruitment postcode(s) [105]

2911 - Crace

Recruitment postcode(s) [106]

2911 - Mitchell

Recruitment postcode(s) [107]

2913 - Casey

Recruitment postcode(s) [108]

2913 - Franklin

Recruitment postcode(s) [109]

2913 - Kinlyside

Recruitment postcode(s) [110]

2913 - Ngunnawal

Recruitment postcode(s) [111]

2913 - Nicholls

Recruitment postcode(s) [112]

2913 - Palmerston

Recruitment postcode(s) [113]

2913 - Taylor

Recruitment postcode(s) [114]

2914 - Amaroo

Recruitment postcode(s) [115]

2914 - Bonner

Recruitment postcode(s) [116]

2914 - Forde

Recruitment postcode(s) [117]

2914 - Harrison

Recruitment postcode(s) [118]

2914 - Moncrieff

Recruitment postcode(s) [119]

2620 - Tharwa

Recruitment postcode(s) [120]

2620 - Hume

Recruitment postcode(s) [121]

2620 - Oaks Estate

Recruitment postcode(s) [122]

2620 - Beard

Recruitment postcode(s) [123]

2905 - Isabella Plains

Recruitment postcode(s) [124]

2905 - Richardson

Recruitment postcode(s) [125]

2611 - Weston

Recruitment postcode(s) [126]

2611 - Cooleman

Recruitment postcode(s) [127]

2611 - Coree

Recruitment postcode(s) [128]

2611 - Mount Stromlo

Recruitment postcode(s) [129]

2611 - Pierces Creek

Recruitment postcode(s) [130]

2611 - Stromlo

Recruitment postcode(s) [131]

2611 - Uriarra Forest

Recruitment postcode(s) [132]

2912 - Gungahlin

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canberra - Faculty of Health

Address [1]

Faculty of Health
University of Canberra
University Dr
Bruce ACT 2617

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

ACT Health

Address [2]

ACT Health - Community Care Program
Phillip Health Centre
Corinna St
Woden ACT 2606

Country [2]

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]

Individual

Name [1]

Judith Barker

Address [1]

Wound Care Nurse Practitioner
ACT Health - Community Care Program
Phillip Health Centre
Corinna St
Woden ACT 2606

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Asst Prof Stephen Isbel

Address [2]

Faculty of Health
University of Canberra
University Dr
Bruce ACT 2617

Country [2]

Australia

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Astris Lifecare

Address [1]

Astris Lifecare - contact Gavin Little
5 Millenium Ct
Silverwater NSW 2128

Country [1]

Australia

Other collaborator category [2]

Commercial sector/Industry

Name [2]

Total Mobility

Address [2]

Total Mobility - contact Victor Setien 58 Maryborough St, Fyshwick ACT 2609

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee

Ethics committee address [1]

ACT Health - Canberra Hospital Campus
PO Box 11
Woden ACT 2606

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/10/2017

Approval date [1]

09/02/2018

Ethics approval number [1]

ETH.10.17.233

Ethics committee name [2]

University of Canberra

Ethics committee address [2]

University of Canberra
Univeristy Dr
Bruce ACT 2617

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

16/02/2018

Ethics approval number [2]

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 were part of the study for up to 8 weeks.

Data collection for this study has now been completed, with data being analysed and prepared for dissemination.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374599-Research Proposal Ethics V2 (FINAL).pdf (Protocol)

Attachments [2]

/AnzctrAttachments/374599-Consent Form.pdf (Participant information/consent)

Attachments [3]

/AnzctrAttachments/374599-Consent for Participation on Behalf of Another Person.pdf (Participant information/consent)

Attachments [4]

/AnzctrAttachments/374599-ACTH Ethics Approval.pdf (Ethics approval)

Attachments [5]

/AnzctrAttachments/374599-UC Cross-Institutional Ethics Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Mrs Katherine E Rae

Address

Occupational Therapist, ACT Health Directorate: Canberra, Australian
PhD Candidate, University of Canberra; Canberra, Australia
Village Creek Health Centre, 37 Kingsmill St, Kambah, ACT, 2905, Australia

Country

Australia

Phone

+61 2 5124 1057

Fax

[email protected]

Contact person for public queries

Name

Katherine Rae

Address

Country

Australia

Phone

+61 2 5124 1057

Fax

[email protected]

Contact person for scientific queries

Name

Katherine E Rae

Address

Country

Australia

Phone

+61 2 5124 1057

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Legislation within ACT jurisdiction requires information of a sensitive nature to be kept in secure locations (Privacy Act 1988, the Health Records (Privacy and Access) Act 1997 (republication No 27) and the APS Code of Conduct). Ethics approval for this study and participant consent does not include making the data available to the wide public.

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.

Trial Review

Documents added manually

Documents added automatically