Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- well-being
研究概览
简要总结
Introduction:
It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI.
Method:
Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI patients without a presser ulcer for the last 2 months
- •Paraplegic and tetraplegic patients
- •complete and incomplete lesion (AIS A, AIS B, AIS C, AIS D)
- •caused by illness or traumatic event
- •smoker and non-smoker
排除标准
- •progressive disease
- •severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
研究组 & 干预措施
new bedsheet
new bedsheet
干预措施: new bedsheet (Device)
conventional bedsheet
conventional bedsheet
干预措施: conventional bedsheet (Device)
结局指标
主要结局
well-being
时间窗: 1 day in the morning after sleeping on the new bed sheet
linear questionnaire (visual analogue scale)
次要结局
- Skin perfusion(1 day in the morning after sleeping on the new bed sheet)
- Skin redness(1 day in the morning after sleeping on the new bed sheet)
- Skin hydration(1 day in the morning after sleeping on the new bed sheet)
- Skin elasticity(1 day in the morning after sleeping on the new bed sheet)