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

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ultracore Repose® mattress
experiences and perceptions of healthcare workers
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring pressure ulcer, Static air mattress, prevention

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

  • Bocasa
  • Residentie Kartuizerhof - Vulpia
  • Woonzorgcentrum Heilig Hart
  • Woonzorgcentrum Egmont
  • Huize Zonnelied

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

residents

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2020
Last Updated
November 16, 2020
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04625348
Brief Title
A Multicentre Clinical Test of the Ultracore Repose® Mattress to Prevent Pressure Ulcers Cat. II-IV in Nursing Homes
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
pressure ulcer, Static air mattress, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
residents
Arm Type
Experimental
Arm Description
daily care of 40 residents will be provided on the Ultracore Repose® mattress
Intervention Type
Device
Intervention Name(s)
Ultracore Repose® mattress
Intervention Description
residents will be placed on the Ultracore Repose® mattress for the daily care during 14 days
Intervention Type
Other
Intervention Name(s)
experiences and perceptions of healthcare workers
Intervention Description
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 Outcome Measure Information:
Title
Incidence rate of pressure ulcers Cat. II-IV
Description
Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices
Time Frame
14 days
Secondary Outcome Measure Information:
Title
caretakers' experiences and perceptions
Description
Insight in caretakers' experiences and perceptions (outcome of the focus group interviews)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Beeckman
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bocasa
City
Heusden-Zolder
State/Province
Limburg
ZIP/Postal Code
3550
Country
Belgium
Facility Name
Residentie Kartuizerhof - Vulpia
City
Lierde
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9572
Country
Belgium
Facility Name
Woonzorgcentrum Heilig Hart
City
Oudenaarde
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Egmont
City
Zottegem
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Huize Zonnelied
City
Ieper
State/Province
West-Vlaanderen
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be available upon request
IPD Sharing Time Frame
on request

Learn more about this trial

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

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