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Completed

NCT Number: NCT05891743

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Siemens Gamesa Renewable Energy (SGRE)

Aveiro, Soza, 3840-346, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Workers from the wind turbine industry

Exclusion criteria

  • Pregnant females
  • Workers previously diagnosed with epoxy resin sensitization

Treatment and study plan

Patch Test

Diagnostic Test

The Patch Test will include the European baseline series, as well as the epoxy and isocyanate series. Additionally, specific products commonly used in the workplace, such as glues, resins, and paints, will be prepared and included in the testing.

Primary outcomes

  1. Prevalence of skin sensitization.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Siemens Gamesa Renewable Energy Blades, S.A.

Industry

Collaborators

  • Association for Innovation and Biomedical Research on Light and Image

Registry information

Official study title

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

Acronym: EPOXY

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2023
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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