Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers
- Conditions
- Pressure UlcerBed SorePressure InjuryPressure Sore
- Interventions
- Device: Repose®
- Registration Number
- NCT03597750
- Lead Sponsor
- University Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 308
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Static air support devices (Repose®) Repose® Alternating-pressure devices will be replaced by static air support devices (Repose®) during 14 days: * Repose® Mattress * Repose® Cushion * Repose® Wedge or Foot Protectors The frequency of repositioning remains unchanged.
- Primary Outcome Measures
Name Time Method Pressure ulcer incidence (Cat. II+) 14 days Development of at least 1 pressure ulcer Cat. II+ during study period
- Secondary Outcome Measures
Name Time Method Patient experiences and perceptions using a static air mattress 14 days Patients experiences and perceptions of comfort using static air support devices and alternating-pressure mattresses. Patient acceptability \[tolerance, (sleep) comfort, pain)
Cost of the intervention (Repose) versus the standard care (Alternating) 14 days Economic measures (from an organizational and patient perspective)
Incidence of incontinence-associated dermatitis (IAD) 14 days Development of at least 1 IAD during study period
Caretakers perceptions of barriers and facilitators to use static air mattress 14 days Nurses acceptability \[barriers and facilitators\].
Trial Locations
- Locations (25)
Woonzorgcentrum Meulenbroek
🇧🇪Hamme, Oost-Vlaanderen, Belgium
Woonzorgcentrum Zonnetij
🇧🇪Aartselaar, Antwerpen, Belgium
Woonzorgcentrum Zonnewende
🇧🇪Aartselaar, Antwerpen, Belgium
Woonzorgcentrum De Mick
🇧🇪Brasschaat, Antwerpen, Belgium
Woonzorgcentrum Egmont
🇧🇪Zottegem, Oost-Vlaanderen, Belgium
Woonzorgcentrum Sint-Vincentius
🇧🇪Avelgem, West-Vlaanderen, Belgium
Woonzorgcentrum Hallenhuis
🇧🇪Brugge, West-Vlaanderen, Belgium
Woonzorgcentrum Ter Potterie
🇧🇪Brugge, West-Vlaanderen, Belgium
Woonzorgcentrum Sint-Maria
🇧🇪Brecht, Antwerpen, Belgium
Woonzorgcentrum Veilige Have
🇧🇪Aalter, Oost-Vlaanderen, Belgium
Woonzorgcentrum Van Zuylen
🇧🇪Brugge, West-Vlaanderen, Belgium
Woonzorgcentrum Sint-Jozef
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Woonzorgcentrum De Vijvers
🇧🇪Gentbrugge, Oost-Vlaanderen, Belgium
Woonzorgcentrum Heilig Hart
🇧🇪Oudenaarde, Oost-Vlaanderen, Belgium
Woonzorgcentrum Huize Zonnelied
🇧🇪Ieper, West-Vlaanderen, Belgium
Woonzorgcentrum Sint-Camillus
🇧🇪Wevelgem, West-Vlaanderen, Belgium
Woonzorgcentrum Minnewater
🇧🇪Brugge, West-Vlaanderen, Belgium
Woonzorgcentrum De Pottelberg
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Woonzorgcentrum Wintershove
🇧🇪Vlamertinge, West-Vlaanderen, Belgium
Woonzorgcentrum Maria Rustoord
🇧🇪Ingelmunster, West-Vlaanderen, Belgium
Woonzorgcentrum Hof Ten Ijzer
🇧🇪Reninge, West-Vlaanderen, Belgium
Woonzorgcentrum De Plataan
🇧🇪Izegem, West-Vlaanderen, Belgium
Woonzorgcentrum OLV Gasthuis
🇧🇪Poperinge, West-Vlaanderen, Belgium
Woonzorgcentrum Sint-Amand
🇧🇪Zwevegem, West-Vlaanderen, Belgium
Woonzorgcentrum De Meers
🇧🇪Waregem, West-Vlaanderen, Belgium