跳至主要内容
临床试验/NCT06294327
NCT06294327已完成不适用

Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)

Vitaz3 个研究点 分布在 1 个国家目标入组 621 人开始时间: 2024年1月22日最近更新:
适应症
干预措施

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

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®)

Experimental

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)

No Intervention

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)

研究者

发起方
Vitaz
申办方类型
Other
责任方
Sponsor

研究点 (3)

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