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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625348
• Other study ID #: BC-06758
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2020
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 66 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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)

Locations

Country	Name	City	State
Belgium	Bocasa	Heusden-Zolder	Limburg
Belgium	Huize Zonnelied	Ieper	West-Vlaanderen
Belgium	Residentie Kartuizerhof - Vulpia	Lierde	Oost-Vlaanderen
Belgium	Woonzorgcentrum Heilig Hart	Oudenaarde	Oost-Vlaanderen
Belgium	Woonzorgcentrum Egmont	Zottegem	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	caretakers' experiences and perceptions	Insight in caretakers' experiences and perceptions (outcome of the focus group interviews)	7 days