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

U

University Ghent

Status

Completed

Conditions

Pressure Ulcer

Treatments

Other: experiences and perceptions of healthcare workers
Device: Ultracore Repose® mattress

Study type

Interventional

Funder types

Other

Identifiers

NCT04625348
BC-06758

Details and patient eligibility

About

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®

Full 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.

Enrollment

40 patients

Sex

All

Ages

66+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

residents
Experimental group
Description:
daily care of 40 residents will be provided on the Ultracore Repose® mattress
Treatment:
Other: experiences and perceptions of healthcare workers
Device: Ultracore Repose® mattress

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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