Pressure UlcerNCT04890678
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
A study testing 22 residentsat risk for PU development and 18 residents at least one PU category III-IV in the sacral area in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 1 site in Belgium.
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 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Pressure Injury, Pressure Sore
- What is being tested?
- 22 residentsat risk for PU development and 18 residents at least one PU category III-IV in the sacral area
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Feb 2019to 30 Oct 2019
- 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 to 110 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
- Bedbound or chair bound
- Aged ≥ 65
Who cannot join
- Short-stay residents (expected length of stay ≤14 days)
- End of life care
- Medical contraindication for patient repositioning/turning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes
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. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.
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 analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
- Being tested
- 22 residentsat risk for PU development, 18 residents at least one PU category III-IV in the sacral area
- Keywords
- support surface, Elderly, Nursing home, prevention, treatment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
22 residentsat risk for PU developmentDevice
mattress in bed
The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.
18 residents at least one PU category III-IV in the sacral areaDevice
mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.
In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed.
| Study group | Role | What they receive |
|---|---|---|
| 22 residentsat risk for PU development | Experimental | 22 residents at risk for PU development, defined by a Braden score < 12 and/or a Braden subscale 'Mobility' score ≤ 2 and/or the presence of non-blanchable erythema in the sacral area.
aged 65 years or over Receives: Device: 22 residentsat risk for PU development |
| 18 residents at least one PU category III-IV in the sacral area | Experimental | 18 residents at least one PU category III-IV in the sacral area aged 65 years or over Receives: Device: 18 residents at least one PU category III-IV in the sacral area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer incidence
Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
Measured: 30 days
Pressure ulcer healing
Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)
Measured: 30 days
Secondary outcomes (1)
Comfort
perceived comfort and experiences of users of the mattress - using self-developed questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start20 Feb 2019
- Primary completion12 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Care of Sweden AB
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, Phd, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890678
- Sponsor's protocol ID
- EC/2018/1291
- Status last verified
- Oct 2019
- First submitted
- 5 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. doi: 10.1186/s13063-016-1703-8.
PubMed 27993145
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes
- ClinicalTrials.gov ID
- NCT04890678
- Acronym / sponsor ID
- EC/2018/1291
- Keywords
- support surface, Elderly, Nursing home, prevention, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Care of Sweden AB
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 12 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.
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 analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22 residentsat risk for PU development | Experimental | Device: 22 residentsat risk for PU development22 residents at risk for PU development, defined by a Braden score < 12 and/or a Braden subscale 'Mobility' score ≤ 2 and/or the presence of non-blanchable erythema in the sacral area. aged 65 years or over |
| 18 residents at least one PU category III-IV in the sacral area | Experimental | Device: 18 residents at least one PU category III-IV in the sacral area18 residents at least one PU category III-IV in the sacral area aged 65 years or over |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
- Bedbound or chair bound
- Aged ≥ 65
Key exclusion criteria (3 listed)
- Short-stay residents (expected length of stay ≤14 days)
- End of life care
- Medical contraindication for patient repositioning/turning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 22 residentsat risk for PU developmentmattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning. | Device | 22 residentsat risk for PU development |
| 18 residents at least one PU category III-IV in the sacral areamattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning. In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed. | Device | 18 residents at least one PU category III-IV in the sacral area |
Primary outcome
Pressure ulcer incidence
Time frame: 30 days
Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
Pressure ulcer healing
Time frame: 30 days
Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)
1 secondary outcome
Comfort
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 27993145Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. doi: 10.1186/s13063-016-1703-8.
- Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Beeckman, Phd principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 22 residentsat risk for PU development and 18 residents at least one PU category III-IV in the sacral area in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 1 site 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 3 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890678, which also lists 1 linked publication.
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 18 May 2021.