Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore

Intervention / Treatment
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* Device: Repose®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Static air support devices (Repose®)<br>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. | Device: Repose®<br>* Repose® Mattress Repose® Cushion Repose® Wedge or Foot Protectors<br>|
| No Intervention: Alternating-pressure devices<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcer incidence (Cat. II+) | 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 | 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 | Nurses acceptability [barriers and facilitators]. | 14 days | 
| Incidence of incontinence-associated dermatitis (IAD) | Development of at least 1 IAD during study period | 14 days | 
| Cost of the intervention (Repose) versus the standard care (Alternating) | Economic measures (from an organizational and patient perspective) | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Static air support devices, Alternating-pressure devices, High risk population, Elderly, Prevention