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临床试验/NCT04559165
NCT04559165Unknown不适用

Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Pressure ulcer scale for healing

研究概览

简要总结

To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients

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
Triple (Participant, Care Provider, Investigator)

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

  • Age more than 18 years old
  • 2-digit Stirling Pressure Sore Severity Scale less than or equal to 2.4
  • No chitosan, sericin, and dimethicone allergy
  • Without skin diseases
  • Without Autoimmune diseases
  • Willingness to participate

排除标准

  • Have uncontrolled diseases
  • Have complication or adverse effects during the time of participation
  • Cannot follow protocol
  • Pregnancy or lactation
  • Participate in other study

结局指标

主要结局

Pressure ulcer scale for healing

时间窗: 21 days

Score 0 to 17, higher scores mean a worse outcome

次要结局

  • Adverse events(21 days)
  • Erythema index(21 days)
  • Melanin index(21 days)
  • Transepidermal water loss(21 days)
  • Moisture index(21 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pornanong Aramwit, Pharm.D., Ph.D

Professor

Chulalongkorn University

研究点 (2)

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