Clinical trial NCT04625348: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: pressure ulcer
Static air mattress
prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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

Primary outcomes:
measure: Incidence rate of pressure ulcers Cat. II-IV
timeFrame: 14 days
Secondary outcomes:
measure: caretakers' experiences and perceptions
timeFrame: 7 days
Other outcomes:
Locations:
city: Heusden-Zolder
country: Belgium
facility: Bocasa
state: Limburg
city: Lierde
country: Belgium
facility: Residentie Kartuizerhof - Vulpia
state: Oost-Vlaanderen
city: Oudenaarde
country: Belgium
facility: Woonzorgcentrum Heilig Hart
state: Oost-Vlaanderen
city: Zottegem
country: Belgium
facility: Woonzorgcentrum Egmont
state: Oost-Vlaanderen
city: Ieper
country: Belgium
facility: Huize Zonnelied
state: West-Vlaanderen
Study officials:
affiliation: University Ghent
name: Dimitri Beeckman
role: PRINCIPAL_INVESTIGATOR
References: