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

Sponsor
Siemens Gamesa Renewable Energy Blades, S.A. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05891743
Collaborator
Association for Innovation and Biomedical Research on Light and Image (Other)
150
5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Patch Test

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Epoxy_Group

Workers who are exposed to epoxy handling procedures, specifically filling and lamination tasks performed by production workers, mainly in finishing areas.

Diagnostic Test: Patch 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.

Non_exposed

Workers from other areas unrelated to epoxy handling procedures, that will be included in the study as the non-exposed control group.

Diagnostic Test: Patch 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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of skin sensitization. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Workers from the wind turbine industry
Exclusion Criteria:
  • Pregnant females

  • Workers previously diagnosed with epoxy resin sensitization

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Siemens Gamesa Renewable Energy Blades, S.A.
  • Association for Innovation and Biomedical Research on Light and Image

Investigators

  • Principal Investigator: Vítor Pinheiro, MD, AIBILI-CEC (AIBILI- Clinical Trials Centre)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Siemens Gamesa Renewable Energy Blades, S.A.
ClinicalTrials.gov Identifier:
NCT05891743
Other Study ID Numbers:
  • LOD_VAG_011
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2023