Impact of Skin Dressings Compared With Cream for Skin Lubrication in the Prevention of Pressure Ulcers in Patients at High or Very High Risk: A Multicenter Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 689
- 试验地点
- 2
- 主要终点
- Pressure ulcers
研究概览
简要总结
Study purpose:
To assess if - in adult patients admitted to hospital with surgical or medical conditions at high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the incidence of in-hospital PU
详细描述
Participants will receive, in addition to the experimental/control interventions, background skin care measures, including anti- bedsore mattresses; body position changes every two hours, and shear/friction reduction.
Trained nurses will review all participants' charts and verify any report of PU until the first ambulation, discharge or death. Patients with a verified PU are referred to the institutional wound care group.
For the purpose of outcome adjudication, study personnel will email digital pictures to 2 independent, blinded outcome assessors (experts in skin care). Skin lesions will be rated in 4-level scale (EPUAP/NPUAP). In case of disagreement, a single, independent referee will confirm the presence/absence of any potential PU.
The unit for analysis will be patients developing (first occurrence, in a time-to-event analysis) PUs in the areas covered by the interventions.
See further details on eligibility, interventions and study outcomes below
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors unaware of the treatment allocation will be sent photographs of the target skin areas with suspected PUs.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients will be eligible if meeting two criteria:
- •Intact skin on hospital admission
- •High/very high risk of PU (Braden´s scale ≤ 20 points) will be eligible.
排除标准
- •Treating physician disagree with participation
- •Need for chronic use of diapers
结局指标
主要结局
Pressure ulcers
时间窗: During hospitalization
First skin ulcer identified in the covered body areas
次要结局
- Length of stay(During hospitalization)
- Time to the first walk(During hospitalization)
- Total cost of hospitalization(During hospitalization)