A Turn and Positioning System and Standardized Incontinence Care Combined With Tailored Repositioning Versus a Standard Repositioning Protocol for Pressure Ulcer Prevention: A Multicenter Prospective Randomized Controlled Clinical Trial and Health Economical Analysis in a Hospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 17
- 主要终点
- Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)
研究概览
简要总结
The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources.
The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed.
The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.
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
- •At risk of developing pressure ulcers (Braden score < 17)
- •Maximum 24hours admitted on the ward at the time of inclusion
- •Expected lenght of stay: 8 days
- •Free of pressure ulcers category II, II, IV and incontinence-associated dermatitis (IAD) category 2 at the start of the study
排除标准
- •Patients with no active or supportive therapy
研究组 & 干预措施
Tailored repositioning + Standardised incontinence care + TAP
A protocol tailored to individual risk factors will be applied to patients at risk.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
干预措施: Comfort Shield® barrier cream cloths (Device)
Tailored repositioning + Standardised incontinence care + TAP
A protocol tailored to individual risk factors will be applied to patients at risk.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
干预措施: A protocol tailored to individual risk factors (Procedure)
Tailored repositioning + Standardised incontinence care + TAP
A protocol tailored to individual risk factors will be applied to patients at risk.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
干预措施: The Prevalon® Turn and Position System 2.0 (Device)
Standard repositioning + Standardised incontinence care + TAP
Instead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
干预措施: The Prevalon® Turn and Position System 2.0 (Device)
Standard repositioning + Standardised incontinence care + TAP
Instead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
干预措施: Comfort Shield® barrier cream cloths (Device)
Usual care
Instead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care. Instead of using comfort Shield® barrier cream cloths, incontinence care will be given to patients using the standard procedure on the ward. Instead of using the turn and position system, patients will be turned according to the standard procedure on the ward.
结局指标
主要结局
Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)
时间窗: within 8 days after the start of the study
The researcher wil collect and administer data about turning compliance and compliance with the protocol
次要结局
- Turning angle(within 8 days after the start of the study)
- Sacrum free of pressure(within 8 days after the start of the study)
- Incidence of pressure ulcers and incontinence-associated dermatitis(within 8 days after the start of the study)
- Comfort and preferences of the caregiver(On baseline and at day 8 (the end of the study))
- Comfort and tolerance of the patient(At day 8 (the end of the study))
- Cost-effectiveness of the prevention of pressure ulcers(For the duration of the study (8 days))
研究者
UCVV
University Centre for Nursing and Midwifery
University Ghent