- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625348
A Multicentre Clinical Test of the Ultracore Repose® Mattress to Prevent Pressure Ulcers Cat. II-IV in Nursing Homes
A Multicentre Clinical Test of the Ultracore Repose® Mattress (Frontier Therapeutics Ltd) to Prevent Pressure Ulcers Cat. II-IV in Belgian Nursing Homes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Heusden-Zolder, Limburg, Belgium, 3550
- Bocasa
-
-
Oost-Vlaanderen
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Lierde, Oost-Vlaanderen, Belgium, 9572
- Residentie Kartuizerhof - Vulpia
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Oudenaarde, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Heilig Hart
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Zottegem, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Egmont
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West-Vlaanderen
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Ieper, West-Vlaanderen, Belgium
- Huize Zonnelied
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: residents
daily care of 40 residents will be provided on the Ultracore Repose® mattress
|
residents will be placed on the Ultracore Repose® mattress for the daily care during 14 days
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
caretakers' experiences and perceptions
Time Frame: 7 days
|
Insight in caretakers' experiences and perceptions (outcome of the focus group interviews)
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dimitri Beeckman, University Ghent
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-06758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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