跳至主要内容
临床试验/NCT03705182
NCT03705182Unknown不适用

Prevention of Dermatitis in Epoxy Exposed Lamination Workers Producing Wind Turbine Blades: An Intervention Study Using Fluorescence Visualization

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
250
试验地点
1
主要终点
Change in prevalence of dermatitis

研究概览

简要总结

The risk of sensitization and contact dermatitis among workers exposed to epoxy resin systems (ERS) is high despite extensive preventive efforts, probably because skin exposure is often left unrecognized.

The main objective of this project is to prevent epoxy-related dermatitis and sensitization, caused by working with ERS, by fluorescence visualization of exposure. In cooperation with global manufacturers of wind turbines, 250 lamination workers will be allocated to either an intervention or a control Group. The risk of dermatitis and sensitization will be compared. Skin exposure will be made visible by a fluorescent tracer added to the ERS. UVA-light will illuminate the skin of head, neck, arms and hands and the fluorescent areas will be recorded and quantified by a computer vision system. The intervention group will be shown the fluorescent areas on their skin, while the control group will not have this information. The intervention takes place daily for a period of 1 month, 4 times during the 2 year follow up period.

All participants are patch tested, screened for dermatitis and atopy at start and end of follow up or at end of employment. The investigators also assess potential determinants for ERS exposure including working tasks and procedures. Information on dermatitis diagnoses from hospital contacts, medical prescriptions and education will be obtained from registers.

详细描述

Objectives The overarching objective is to reduce the risk of dermatitis and sensitization when working with epoxy resin systems.

Specific aims are:

  • To identify work procedures at increased risk of dermal exposure to epoxy resins

  • To examine if fluorescence visualization of dermal exposure to epoxy resins reduces the risk of:

  • subsequent dermal exposure to epoxy resins

  • dermatitis

  • sensitization to epoxy resins

  • To examine the risk of dermatitis following sensitization to ERS components

  • To examine the course of sensitization to ERS components.

Materials and methods Study population The study population is 250 employees of two factories producing rotor blades for wind turbines. The participants all have daily manual work with ERS. Participants will be recruited through the Health Safety and Environment (HSE) organizations by oral and written information. Current employees will be followed for 2 years. Employees employed during the study will continuously be recruited and followed until end of follow up, 2 years after study start.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •18 years of age or more
  • •Understand Danish or English

排除标准

  • •Pregnant women
  • •Severe dermatitis
  • •Current treatment with prednisolone

研究组 & 干预措施

Interventiongroup

Experimental

The intervention group will be shown the fluorescent areas on their skin (fluorescence visualization feedback)

干预措施: Fluorescence visualization (feedback) (Device)

Control group

No Intervention

The control group will not be shown the fluorescent areas on their skin (no feedback)

结局指标

主要结局

Change in prevalence of dermatitis

时间窗: At start and after 2 years

Diagnosed by clinical examinations

Change in sensitization

时间窗: At start and after 2 years

Assesed by patch test

次要结局

  • Change in fluorescence levels(1 month x 4, over 2 years)
  • Change in number of fluorescence recordings(1 months x 4, over 2 years)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验