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临床试验/NCT04449575
NCT04449575Unknown不适用

Hand Eczema in the Health Care Sector

University Hospital Bispebjerg and Frederiksberg1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Staphyloccous aureus presence

研究概览

简要总结

This project aims to investigate the prevalence of bacterial colonization and associated factors in health care workers with hand eczema with focus on Staphylococcus aureus.

详细描述

Two groups will be examined in this study: health care workers with HE and matched controls invited through a questionnaire study which will be sent to approximately 4000 health care workers in Capital Region. Samples from health care workers with and without hand eczema will be collected after obtaining their written informed consent. Collection of samples: Swabs will be rubbed on the skin for 30 seconds on lesional and non-lesional skin on the dominating hand and from the nostrils. The swabs will immediately be stored in -80 C° (research biobank) for subsequent analysis at Statens Serum Institute.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The diagnosis of hand eczema (for group with hand eczema)

排除标准

  • Other skin diseases (in both groups)

结局指标

主要结局

Staphyloccous aureus presence

时间窗: Baseline, cross-sectional

Prevalence of S. aureus colonization on hands and in nose in two groups of health care workers. The swab samples will be assessed by culturing on selective S. aureus plates (chromID S. aureus; bioMerieux, Marcy l'Etoile, France) and incubated overnight at 37 °C. DNA will be purified from S. aureus isolates using the Qiagen DNeasy Blood and Tissue Purification Kit (Qiagen, Hilden, Germany).

次要结局

  • CC-types and spa-typing(Baseline, cross-sectional)
  • Hand Eczema Severity Index (HECSI)(Baseline, cross-sectional)

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Topal Yüksel

MD

University Hospital Bispebjerg and Frederiksberg

研究点 (1)

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