Pressure UlcerNCT04625348
A Multicentre Clinical Test of the Ultracore Repose® Mattress to Prevent Pressure Ulcers Cat. II-IV in Nursing Homes
A study testing Ultracore Repose® mattress and experiences and perceptions of healthcare workers in people with Pressure Ulcer, run by University Ghent at 5 sites in Belgium.
Trial summary
A mixed method desgin study will be conducted to study pressure ulcer incidence Cat. II-IV (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the Ultracore Repose® mattress (Frontier therapeutics Ltd) and to study differences in caretakers' experiences and perceptions when… Read more about this study
- Who is it for?
- Ages 66 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Ultracore Repose® mattress and experiences and perceptions of healthcare workers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesBelgium
- Study dates
- 15 Feb 2020to 5 Nov 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 66 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Bocasa
Heusden-Zolder, Limburg, 3550
Huize Zonnelied
Ieper, West-Vlaanderen
Residentie Kartuizerhof - Vulpia
Lierde, Oost-Vlaanderen, 9572
Woonzorgcentrum Heilig Hart
Oudenaarde, Oost-Vlaanderen
Woonzorgcentrum Egmont
Zottegem, Oost-Vlaanderen
About this study
Official title: A Multicentre Clinical Test of the Ultracore Repose® Mattress (Frontier Therapeutics Ltd) to Prevent Pressure Ulcers Cat. II-IV in Belgian Nursing Homes
A mixed method desgin study will be conducted to study pressure ulcer incidence Cat. II-IV (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the Ultracore Repose® mattress (Frontier therapeutics Ltd) and to study differences in caretakers' experiences and perceptions when using the Ultracore Repose® mattress versus the Repose overlay mattress®
Read the detailed description
Quantitative part:
Before the start of the study, nurses on the participating wards will be educated by the researcher about skin observation, pressure ulcer classification, risk assessment, risk assessment, and use of the Ultracore Repose® mattress (Frontier therapeutics Ltd).
Skin assessment and risk assessment are performed on a daily basis by the staff nurses. Reliability testing will be done by the researcher on a weekly basis and without pre-announcement. Reliability checks and compliance with the protocol will be completed by the researcher as well as the collection of additional data.
Qualitative part
Three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress).The researcher will encourage group interactions to capture the data and to provide a more comprehensive understanding of experiences and perceptions of using the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress). Non-verbal communication will also be captured in each focus group.
- Conditions
- Pressure Ulcer
- Being tested
- Ultracore Repose® mattress, experiences and perceptions of healthcare workers
- Keywords
- pressure ulcer, Static air mattress, prevention
- 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 for the daily care during 14 days
experiences and perceptions of healthcare workersOther
Three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress)
| Study group | Role | What they receive |
|---|---|---|
| residents | Experimental | daily care of 40 residents will be provided on the Ultracore Repose® mattress Receives: Device: Ultracore Repose® mattress; Other: experiences and perceptions of healthcare workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of pressure ulcers Cat. II-IV
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)
caretakers' experiences and perceptions
Insight in caretakers' experiences and perceptions (outcome of the focus group interviews)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start15 Feb 2020
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- 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
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625348
- Sponsor's protocol ID
- BC-06758
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Clinical Test of the Ultracore Repose® Mattress (Frontier Therapeutics Ltd) to Prevent Pressure Ulcers Cat. II-IV in Belgian Nursing Homes
- ClinicalTrials.gov ID
- NCT04625348
- Acronym / sponsor ID
- BC-06758
- Conditions
- Pressure Ulcer
- Keywords
- pressure ulcer, Static air mattress, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 12 Nov 2020 (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.
A mixed method desgin study will be conducted to study pressure ulcer incidence Cat. II-IV (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the Ultracore Repose® mattress (Frontier therapeutics Ltd) and to study differences in caretakers' experiences and perceptions when using the Ultracore Repose® mattress versus the Repose overlay mattress®
Detailed description
Quantitative part:
Before the start of the study, nurses on the participating wards will be educated by the researcher about skin observation, pressure ulcer classification, risk assessment, risk assessment, and use of the Ultracore Repose® mattress (Frontier therapeutics Ltd).
Skin assessment and risk assessment are performed on a daily basis by the staff nurses. Reliability testing will be done by the researcher on a weekly basis and without pre-announcement. Reliability checks and compliance with the protocol will be completed by the researcher as well as the collection of additional data.
Qualitative part
Three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress).The researcher will encourage group interactions to capture the data and to provide a more comprehensive understanding of experiences and perceptions of using the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress). Non-verbal communication will also be captured in each focus group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| residents | Experimental | Device: Ultracore Repose® mattress, Other: experiences and perceptions of healthcare workersdaily care of 40 residents will be provided on the Ultracore Repose® mattress |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Ultracore Repose® mattressresidents will be placed on the Ultracore Repose® mattress for the daily care during 14 days | Device | residents |
| experiences and perceptions of healthcare workersThree focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress) | Other | residents |
Primary outcome
Incidence rate of pressure ulcers Cat. II-IV
Time frame: 14 days
Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices
1 secondary outcome
caretakers' experiences and perceptions
Time frame: 7 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 Nov 2020.
- Individual participant dataSharing planned: Yes. data will be available upon request
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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 principal investigator
University Ghent
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultracore Repose® mattress and experiences and perceptions of healthcare workers in people with Pressure Ulcer, 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 4 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 Nov 2020. 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?
Incidence rate of pressure ulcers Cat. II-IV (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 18 Nov 2020.