Clinical trial NCT03597750: Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers
Official title: Pressure Ulcer Prevention Using Static Air Support Devices (Repose®) Versus Alternating-Pressure Devices in a High Risk Population in Nursing Homes: A Multi-Center Prospective Randomized Controlled Trial and Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Pressure Injury
Pressure Sore
Bed Sore
Keywords: Static air support devices
Alternating-pressure devices
High risk population
Elderly
Prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Frontier Medical Group, UK
First posted: 2018-07-24
Enrollment: 308
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Maintaining and improving skin health are major goals in acute and long-term care. Patients at the extremes of age, the critically ill, medically compromised and those with immobility are at risk for developing several skin disorders, with pressure ulcers (PUs) as one of the most common and mostly preventable ones. Prevalence figures of PUs vary between 6.4% and 31.4%. PUs are described as localised injuries to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure combined with shear. Prevention of PUs is internationally seen to be a key quality indicator of care. To prevent PUs, reducing both the amount and the duration of pressure and shear at the pressure points of the body is strongly recommended. One of the interventions to achieving this, is the use of pressure-reducing devices (mattresses, cushions, etc.). Studies that compare the (cost-) effectiveness of different pressure-reducing devices are needed.

The primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer prevention in high risk patients using static air support devices (Repose®) versus alternating-pressure devices. The second aim is to get insight in patients' experiences and perceptions of comfort using static air support devices and alternating-pressure devices. The third aim is to get insight in caretakers' perceptions of barriers and facilitators of the use of static air support devices and alternating-pressure devices and to reveal how these perceptions influence the readiness to use the products in clinical practice.

This randomized controlled trial will be performed in ca. 25 nursing homes in a random sample of 306 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.


Eligibility criteria: Inclusion Criteria:

* High risk of pressure ulcers (Braden score \< 12) and/or pressure ulcer category 1
* Currently using alternating-pressure devices
* Bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair)
* Aged \> 65 years

Exclusion Criteria:

* Pressure ulcer category 2,3,4, 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: Pressure ulcer incidence (Cat. II+)
timeFrame: 14 days
Secondary outcomes:
measure: Patient experiences and perceptions using a static air mattress
timeFrame: 14 days
measure: Caretakers perceptions of barriers and facilitators to use static air mattress
timeFrame: 14 days
measure: Incidence of incontinence-associated dermatitis (IAD)
timeFrame: 14 days
measure: Cost of the intervention (Repose) versus the standard care (Alternating)
timeFrame: 14 days
Other outcomes:
Locations:
city: Aartselaar
country: Belgium
facility: Woonzorgcentrum Zonnetij
state: Antwerpen
city: Aartselaar
country: Belgium
facility: Woonzorgcentrum Zonnewende
state: Antwerpen
city: Brasschaat
country: Belgium
facility: Woonzorgcentrum De Mick
state: Antwerpen
city: Brecht
country: Belgium
facility: Woonzorgcentrum Sint-Maria
state: Antwerpen
city: Aalter
country: Belgium
facility: Woonzorgcentrum Veilige Have
state: Oost-Vlaanderen
city: Assenede
country: Belgium
facility: Woonzorgcentrum Sint-Jozef
state: Oost-Vlaanderen
city: Gentbrugge
country: Belgium
facility: Woonzorgcentrum De Vijvers
state: Oost-Vlaanderen
city: Hamme
country: Belgium
facility: Woonzorgcentrum Meulenbroek
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: Avelgem
country: Belgium
facility: Woonzorgcentrum Sint-Vincentius
state: West-Vlaanderen
city: Brugge
country: Belgium
facility: Woonzorgcentrum Hallenhuis
state: West-Vlaanderen
city: Brugge
country: Belgium
facility: Woonzorgcentrum Minnewater
state: West-Vlaanderen
city: Brugge
country: Belgium
facility: Woonzorgcentrum Ter Potterie
state: West-Vlaanderen
city: Brugge
country: Belgium
facility: Woonzorgcentrum Van Zuylen
state: West-Vlaanderen
city: Ieper
country: Belgium
facility: Woonzorgcentrum Huize Zonnelied
state: West-Vlaanderen
city: Ingelmunster
country: Belgium
facility: Woonzorgcentrum Maria Rustoord
state: West-Vlaanderen
city: Izegem
country: Belgium
facility: Woonzorgcentrum De Plataan
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: Woonzorgcentrum De Pottelberg
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: Woonzorgcentrum Sint-Jozef
state: West-Vlaanderen
city: Poperinge
country: Belgium
facility: Woonzorgcentrum OLV Gasthuis
state: West-Vlaanderen
city: Reninge
country: Belgium
facility: Woonzorgcentrum Hof Ten Ijzer
state: West-Vlaanderen
city: Vlamertinge
country: Belgium
facility: Woonzorgcentrum Wintershove
state: West-Vlaanderen
city: Waregem
country: Belgium
facility: Woonzorgcentrum De Meers
state: West-Vlaanderen
city: Wevelgem
country: Belgium
facility: Woonzorgcentrum Sint-Camillus
state: West-Vlaanderen
city: Zwevegem
country: Belgium
facility: Woonzorgcentrum Sint-Amand
state: West-Vlaanderen
Study officials:
affiliation: University Ghent
name: Dimitri Beeckman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Middleton V, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD001735. doi: 10.1002/14651858.CD001735.pub5.
citation: Serraes B, Beeckman D. Static Air Support Surfaces to Prevent Pressure Injuries: A Multicenter Cohort Study in Belgian Nursing Homes. J Wound Ostomy Continence Nurs. 2016 Jul-Aug;43(4):375-8. doi: 10.1097/WON.0000000000000244.