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临床试验/NCT04194541
NCT04194541已完成不适用

Wound Dressings for Hidradenitis Suppurativa

University of Miami2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Dermatology Life Quality Index (DLQI) Scores

研究概览

简要总结

The primary purpose of this research is to determine how the types of wound dressings affect quality of life for people with Hidradenitis Suppurativa (HS).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Men and women ≥18 years of age
  • Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist
  • Presence of at least one lesion with active drainage
  • Willing and able to provide informed consent

排除标准

  • Subjects younger than 18-years-old.
  • Prisoners
  • Pregnant or lactating women
  • Adults unable to consent

结局指标

主要结局

Dermatology Life Quality Index (DLQI) Scores

时间窗: At Baseline, at 6 Weeks

Participant quality of life as measured via DLQI. DLQI has a total score ranging from 0-30 with the higher score indicating more impairment on the participant's quality of life.

次要结局

  • Number of Participants Reporting Dressing Preference for Each Specific Body Part(Visit 1 (Day 14))
  • Average Frequency of Dressing Changes(6 Weeks)
  • Odor Rating(At Baseline, at 6 Weeks)
  • Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading(At 6 Weeks)
  • Average Pain as Assessed by the Numerical Rating Scale (NRS)(At Baseline, at 6 Weeks)
  • Number of Participants Reporting Overall Dressing Preference for Specific Body Part(At Baseline)
  • Maximal Pain as Assessed by the Numerical Rating Scale (NRS)(At Baseline, at 6 Weeks)
  • Sleep Rating(At Baseline, at 6 Weeks)
  • Drainage Rating(At Baseline, at 6 Weeks)

研究者

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

Hadar Lev-Tov

Assistant Professor

University of Miami

研究点 (2)

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