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

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Device: Ultracore Repose® mattress; Other: experiences and perceptions of healthcare workers

• Registration Number: NCT04625348
• Lead Sponsor: University Ghent

Brief 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 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 Timeline

• Study Start: 2020-02-15
• Status Verified: 2020-11
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
residents	Ultracore Repose® mattress	daily care of 40 residents will be provided on the Ultracore Repose® mattress
residents	experiences and perceptions of healthcare workers	daily care of 40 residents will be provided on the Ultracore Repose® mattress

Primary Outcome Measures

Name	Time	Method
Incidence rate of pressure ulcers Cat. II-IV	14 days	Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices

Secondary Outcome Measures

Name	Time	Method
caretakers' experiences and perceptions	7 days	Insight in caretakers' experiences and perceptions (outcome of the focus group interviews)

Trial Locations

Locations (5)

Bocasa; 🇧🇪 Heusden-Zolder, Limburg, Belgium

Residentie Kartuizerhof - Vulpia; 🇧🇪 Lierde, Oost-Vlaanderen, Belgium

Woonzorgcentrum Egmont; 🇧🇪 Zottegem, Oost-Vlaanderen, Belgium

Huize Zonnelied; 🇧🇪 Ieper, West-Vlaanderen, Belgium

Woonzorgcentrum Heilig Hart; 🇧🇪 Oudenaarde, Oost-Vlaanderen, Belgium