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Pressure UlcerNCT05142878

What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?

A study testing Ultracore Repose® mattress in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 5 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pressure ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 20 community patients. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Pressure Ulcer, Pressure Injury, Pressure Sore
What is being tested?
Ultracore Repose® mattress
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesBelgium
Study dates
15 Jul 2020to 1 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • High risk of pressure ulcers (Braden score < 12) and/or pressure ulcer category 1,
  • Bedbound (> 8 hours in bed) or chair bound (> 8 hours in chair),
  • Aged > 65 years,

Who cannot join

  • Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer,
  • Expected length of stay < 2 weeks,
  • End of life care,
  • Medical contraindication for use of static air support devices
  • Caretakers:
  • Caretakers will be included in the focus group interviews if they have experience with the use of both the Ultracore Repose® mattress and the Repose overlay mattress®

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites
  • Woonzorgcentrum Ter Potterie

    Bruges, West-Vlaanderen

  • Huize Zonnelied

    Ieper, West-Vlaanderen

  • De Plataan

    Izegem, West-Vlaanderen

  • WZC Heilig Hart

    Oudenaarde, Osst-Vlaanderen

  • WZC Egmont

    Zottegem, Oost-Vlaanderen

Other trials in Belgium

About this study

Official title: Pressure Ulcer Prevention Using Static Air Foam Hybrid Mattress (Ultracore Repose®) in a High Risk Population in Nursing Homes: A Multi-Center Cohort and Qualitative Study

Pressure ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 20 community patients. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare.

International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals.

Read more

A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.

Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions.

A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). Static or reactive overlay mattresses are an example of a low-tech constant low pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium.

A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population.

This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.

Being tested
Ultracore Repose® mattress
Keywords
static air support devices, High risk population, Elderly, Prevention, Pressure Ulcer
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultracore Repose® mattressDevice

    Residents will be placed on the Ultracore Repose® mattress during 14 days

Study groups in NCT05142878
Study groupRoleWhat they receive
Experimental: Static air support devices (Ultracore Repose®)ExperimentalResidents will be placed on a static air foam hybrid mattress during 14 days: • Ultracore Repose® Mattress
Receives: Device: Ultracore Repose® mattress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure ulcer incidence (Cat. II+)

    Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices

    Measured: 14 days

Secondary outcomes (1)
  1. Insight in caretakers' experiences and perceptions

    Insight in caretakers' experiences and perceptions (outcome of the focus group interviews) after using Static Air Foam Hybrid Mattress

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start15 Jul 2020
  3. Primary completion1 Sep 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142878
Sponsor's protocol ID
EC/2020/BC-06758
Other IDs
EC/2020/BC-06758
Status last verified
Nov 2021
First submitted
19 Nov 2021
Last updated
29 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultracore Repose® mattress in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 5 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure ulcer incidence (Cat. II+) (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.

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