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临床试验/NCT02020655
NCT02020655已完成不适用

Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
IL-1 α concentration (pg/ml)

研究概览

简要总结

Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas exposed to pressure, shear and friction. Shear- force is an important contributing factor and wound dressing are possibly capable to reduce shear force at the skin. At this moment there's no good marker to detect the effect of shear- force at the skin. A potential marker could be cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study have shown a significant increased level of IL-1α after the application of pressure. We want to investigate if these cytokines are significant increased after the application of shear- force at the skin.

Objective: The objective of this study is to gather knowledge about cytokine concentrations (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to use this knowledge in the future to investigate if different prophylactic wound dressings are capable to reduce shear force at the skin. This could be interesting in the prevention of pressure ulcers.

Study design: With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes. As a control we ware going to put the shear- force model at the other arm without the application of shear- force. Before the use of the shear- force model we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb cytokines from the skin. After the use of the shear force- model we will perform cytokine measurements again. Then we will extract the cytokines from the Sebutape with the use of ELISA.

Study population: 10 Healthy volunteers Age 18- 30 years

Primary outcome: IL-1 α concentration (pg/ml)

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18- 30 years
  • BMI 20 -30
  • Braden score > 20

排除标准

  • Trauma arms
  • Skin diseases (eczema, psoriasis)
  • Inability to give informed consent
  • Muscle disorders
  • malignancy

结局指标

主要结局

IL-1 α concentration (pg/ml)

时间窗: up to 24 hours

With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes. As a control we ware going to put the shear- force model at the other arm without the application of shear- force. Before the use of the shear- force model we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb cytokines from the skin. After the use of the shear force- model we will perform cytokine measurements again.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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