Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vitaz
- 入组人数
- 621
- 试验地点
- 3
- 主要终点
- Incidence of pressure ulcer, category > I
研究概览
简要总结
Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).
The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research & Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.
This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period > 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward 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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Norton score < 14
- •Bed and/or chairfast
- •no pressure ulcers or at least pressure ulcer category I
排除标准
- •Norton Score >/=14
- •Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer
- •Expected length of hospital stay < 2 days
- •Medical contraindication for use of reactive static air support surfaces
- •End of life care (or Do Not Reanimate (DNR) code IV)
- •Age < 18 years
研究组 & 干预措施
Reactive static air support surfaces (Repose®)
Intervention with Repose® devices
Standard repositioning protocol is applied.
干预措施: Reactive static air support surfaces (Device)
Alternating air pressure mattress (ArjoHuntleigh® Alpha Response)
Standard care with mattress type: ArjoHuntleigh® Alpha Response
Standard repositioning protocol is applied.
结局指标
主要结局
Incidence of pressure ulcer, category > I
时间窗: After admission
Development of a pressure ulcer category \> I
次要结局
- Cost of alternating air pressure mattress compared to reactive static air support surfaces(After admission)
- Patient comfort(After admission)
