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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04625348
Enrollment
40
Registered
2020-11-12
Start date
2020-02-15
Completion date
2020-11-05
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

pressure ulcer, Static air mattress, prevention

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.

Interventions

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

OTHERexperiences 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)

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence rate of pressure ulcers Cat. II-IV14 daysIncidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices

Secondary

MeasureTime frameDescription
caretakers' experiences and perceptions7 daysInsight in caretakers' experiences and perceptions (outcome of the focus group interviews)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026