Skip to main content
OpenTrials
Completed

NCT Number: NCT04625348

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bocasa, Heusden-Zolder, Limburg, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultracore Repose® mattress

Device

residents will be placed on the Ultracore Repose® mattress for the daily care during 14 days

experiences and perceptions of healthcare workers

Other

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. caretakers' experiences and perceptions

    Time frame: 7 days

    Insight in caretakers' experiences and perceptions (outcome of the focus group interviews)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.