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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 66 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Ultracore Repose® mattress	residents will be placed on the Ultracore Repose® mattress for the daily care during 14 days
OTHER	experiences and perceptions of healthcare workers	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)

Timeline

• Start date: 2020-02-15
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2020-11-12
• Last updated: 2020-11-18

Locations

5 sites across 1 country: Belgium