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临床试验/NCT05891743
NCT05891743已完成不适用

Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry

Siemens Gamesa Renewable Energy Blades, S.A.1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
Prevalence of skin sensitization.

研究概览

简要总结

The goal of this observational study it to learn about the prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind turbine industry. The main question it aims to answer is:

  • What is the prevalence of skin sensitization and dermatitis among workers in the wind turbine industry who are exposed to epoxy?

Participants will be asked to perform Patch Test, which is considered the Gold Standard test for identifying the cause of occupational contact allergic dermatitis.

Researchers will compare the results of the epoxy-exposed group with those of a control group comprising non-exposed workers from the same industry. This analysis will help determine if there is a higher prevalence of skin sensitization among workers exposed to epoxy.

详细描述

Epoxy resin systems are widely used materials in various industries due to their high mechanical, chemical, and thermal resistance. These systems are commonly employed as protective coatings, adhesives, and paints, as well as in the manufacturing of composites in the plastics industry. Epoxy components are well-known sensitizers of the skin. A high prevalence of skin sensitization and dermatitis have been reported among workers exposed to epoxy components. It is recommended to use comprehensive protective equipment when handling epoxy components. In the wind turbine industry, tasks involving epoxy handling, such as lamination and filling procedures, are frequently performed. Recent study have shown a sensitization prevalence of 8.9% among workers performing these tasks, while a previous study reported a high sensitization rate of 10.5% to epoxy resins. Despite efforts to find alternatives to epoxy resin systems and improve protective measures, the use of epoxy has increased, and some countries have implemented more stringent regulations, such as Denmark. In Portugal, there are currently no specific regulations regarding epoxy handling, and no certification is required for working with epoxy. Siemens Gamesa Renewable Energy, in Portugal, faces many skin problems among production workers, however numbers are unknown. Therefore, the main purpose of the study is to evaluate the prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind Turbine Industry.

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

  • Workers from the wind turbine industry

排除标准

  • Pregnant females
  • Workers previously diagnosed with epoxy resin sensitization

结局指标

主要结局

Prevalence of skin sensitization.

时间窗: 2-3 days

Allergens will be applied to the participant's back using IQ Chambers® (Chemotechnique) and secured with 4fix® adhesive tape for 48 hours. Readings will be conducted on day 2-3 and, if necessary, on days 4-7, following the ESCD guidelines.

次要结局

未报告次要终点

研究者

发起方
Siemens Gamesa Renewable Energy Blades, S.A.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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