- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03597750
Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antwerpen
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Aartselaar, Antwerpen, Belgium
- Woonzorgcentrum Zonnetij
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Aartselaar, Antwerpen, Belgium
- Woonzorgcentrum Zonnewende
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Brasschaat, Antwerpen, Belgium
- Woonzorgcentrum De Mick
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Brecht, Antwerpen, Belgium
- Woonzorgcentrum Sint-Maria
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Oost-Vlaanderen
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Aalter, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Veilige Have
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Assenede, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Sint-Jozef
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Gentbrugge, Oost-Vlaanderen, Belgium
- Woonzorgcentrum De Vijvers
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Hamme, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Meulenbroek
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Oudenaarde, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Heilig Hart
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Zottegem, Oost-Vlaanderen, Belgium
- Woonzorgcentrum Egmont
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West-Vlaanderen
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Avelgem, West-Vlaanderen, Belgium
- Woonzorgcentrum Sint-Vincentius
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Brugge, West-Vlaanderen, Belgium
- Woonzorgcentrum Hallenhuis
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Brugge, West-Vlaanderen, Belgium
- Woonzorgcentrum Minnewater
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Brugge, West-Vlaanderen, Belgium
- Woonzorgcentrum Ter Potterie
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Brugge, West-Vlaanderen, Belgium
- Woonzorgcentrum Van Zuylen
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Ieper, West-Vlaanderen, Belgium
- Woonzorgcentrum Huize Zonnelied
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Ingelmunster, West-Vlaanderen, Belgium
- Woonzorgcentrum Maria Rustoord
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Izegem, West-Vlaanderen, Belgium
- Woonzorgcentrum De Plataan
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Kortrijk, West-Vlaanderen, Belgium
- Woonzorgcentrum De Pottelberg
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Kortrijk, West-Vlaanderen, Belgium
- Woonzorgcentrum Sint-Jozef
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Poperinge, West-Vlaanderen, Belgium
- Woonzorgcentrum OLV Gasthuis
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Reninge, West-Vlaanderen, Belgium
- Woonzorgcentrum Hof Ten Ijzer
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Vlamertinge, West-Vlaanderen, Belgium
- Woonzorgcentrum Wintershove
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Waregem, West-Vlaanderen, Belgium
- Woonzorgcentrum De Meers
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Wevelgem, West-Vlaanderen, Belgium
- Woonzorgcentrum Sint-Camillus
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Zwevegem, West-Vlaanderen, Belgium
- Woonzorgcentrum Sint-Amand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Static air support devices (Repose®)
Alternating-pressure devices will be replaced by static air support devices (Repose®) during 14 days:
The frequency of repositioning remains unchanged. |
|
NO_INTERVENTION: Alternating-pressure devices
Instead of replacing the alternating-pressure devices by static air support devices (Repose®), the residents remain on their alternating-pressure devices. The frequency of repositioning remains unchanged. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure ulcer incidence (Cat. II+)
Time Frame: 14 days
|
Development of at least 1 pressure ulcer Cat.
II+ during study period
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient experiences and perceptions using a static air mattress
Time Frame: 14 days
|
Patients experiences and perceptions of comfort using static air support devices and alternating-pressure mattresses.
Patient acceptability [tolerance, (sleep) comfort, pain)
|
14 days
|
Caretakers perceptions of barriers and facilitators to use static air mattress
Time Frame: 14 days
|
Nurses acceptability [barriers and facilitators].
|
14 days
|
Incidence of incontinence-associated dermatitis (IAD)
Time Frame: 14 days
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Development of at least 1 IAD during study period
|
14 days
|
Cost of the intervention (Repose) versus the standard care (Alternating)
Time Frame: 14 days
|
Economic measures (from an organizational and patient perspective)
|
14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2017/0266
- B670201731706 (OTHER: Ethics Committee UZ Gent)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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