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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 26
- 主要终点
- Pressure ulcer incidence (Cat. II+)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Static air support devices (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.
干预措施: Repose® (Device)
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.
结局指标
主要结局
Pressure ulcer incidence (Cat. II+)
时间窗: 14 days
Development of at least 1 pressure ulcer Cat. II+ during study period
次要结局
- Patient experiences and perceptions using a static air mattress(14 days)
- Cost of the intervention (Repose) versus the standard care (Alternating)(14 days)
- Incidence of incontinence-associated dermatitis (IAD)(14 days)
- Caretakers perceptions of barriers and facilitators to use static air mattress(14 days)
研究者
UCVV
University Centre for Nursing and Midwifery
University Ghent