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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000319279
Enrollment
16
Registered
2018-03-05
Start date
2018-03-26
Completion date
2022-04-28
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 bein

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.

Sponsors

Katherine Rae
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026