A Multicentre Clinical Test of the Ultracore Repose® Mattress to Prevent Pressure Ulcers Cat. II-IV in Nursing Homes

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicentre Clinical Test of the Ultracore Repose® Mattress (Frontier Therapeutics Ltd) to Prevent Pressure Ulcers Cat. II-IV in Belgian Nursing Homes

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: Ultracore Repose® mattress
* Other: experiences and perceptions of healthcare workers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: residents<br>daily care of 40 residents will be provided on the Ultracore Repose® mattress | Device: Ultracore Repose® mattress<br>* residents will be placed on the Ultracore Repose® mattress for the daily care during 14 days<br>Other: experiences and perceptions of healthcare workers<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caretakers' experiences and perceptions | Insight in caretakers' experiences and perceptions (outcome of the focus group interviews) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure ulcer, Static air mattress, prevention