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

NCT04625348 | Completed

• 1 other identifier: BC-06758
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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®

Conditions

Pressure Ulcer

Keywords

pressure ulcer; Static air mattress; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• caretakers' experiences and perceptions

  7 days

Study Arms (1)

residents

EXPERIMENTAL

daily care of 40 residents will be provided on the Ultracore Repose® mattress

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

Interventions

Ultracore Repose® mattress DEVICE

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

residents

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)

residents

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (5)

Bocasa

Heusden-Zolder, Limburg, 3550, Belgium

Location

Residentie Kartuizerhof - Vulpia

Lierde, Oost-Vlaanderen, 9572, Belgium

Location

Woonzorgcentrum Heilig Hart

Oudenaarde, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum Egmont

Zottegem, Oost-Vlaanderen, Belgium

Location

Huize Zonnelied

Ieper, West-Vlaanderen, Belgium

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dimitri Beeckman

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: February 15, 2020
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: on request

Locations

BE (5)