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

NCT ID: NCT05891743

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-08

Study Completion Date

2024-10-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dermatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Epoxy_Group

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

Patch Test

Intervention Type 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.

Non_exposed

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

Patch Test

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Workers from the wind turbine industry

Exclusion Criteria

* Pregnant females
* Workers previously diagnosed with epoxy resin sensitization
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role collaborator

Siemens Gamesa Renewable Energy Blades, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VĂ­tor Pinheiro, MD

Role: PRINCIPAL_INVESTIGATOR

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Locations

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Siemens Gamesa Renewable Energy (SGRE)

Aveiro, Soza, Portugal

Site Status

Countries

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Portugal

References

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Aalto-Korte K, Pesonen M, Suuronen K. Occupational allergic contact dermatitis caused by epoxy chemicals: occupations, sensitizing products, and diagnosis. Contact Dermatitis. 2015 Dec;73(6):336-42. doi: 10.1111/cod.12445. Epub 2015 Jul 30.

Reference Type BACKGROUND
PMID: 26230376 (View on PubMed)

Prodi A, Rui F, Fortina AB, Corradin MT, Filon FL. Occupational sensitization to epoxy resins in Northeastern Italy (1996-2010). Int J Occup Environ Health. 2015;21(1):82-7. doi: 10.1179/2049396714Y.0000000095.

Reference Type BACKGROUND
PMID: 25633931 (View on PubMed)

Geier J, Lessmann H, Hillen U, Skudlik C, Jappe U. Sensitization to reactive diluents and hardeners in epoxy resin systems. IVDK data 2002-2011. Part II: concomitant reactions. Contact Dermatitis. 2016 Feb;74(2):94-101. doi: 10.1111/cod.12490. Epub 2015 Nov 5.

Reference Type BACKGROUND
PMID: 26537833 (View on PubMed)

Christiansen AG, Carstensen O, Sommerlund M, Clausen PA, Bonlokke JH, Schlunssen V, Isaksson M, Schmidt SAJ, Kolstad HA. Prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind turbine industry. Br J Dermatol. 2022 Dec;187(6):988-996. doi: 10.1111/bjd.21830. Epub 2022 Sep 16.

Reference Type BACKGROUND
PMID: 35972390 (View on PubMed)

Ponten A, Carstensen O, Rasmussen K, Gruvberger B, Isaksson M, Bruze M. Epoxy-based production of wind turbine rotor blades: occupational contact allergies. Dermatitis. 2004 Mar;15(1):33-40. doi: 10.2310/6620.2004.20433.

Reference Type BACKGROUND
PMID: 15573646 (View on PubMed)

Other Identifiers

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LOD_VAG_011

Identifier Type: -

Identifier Source: org_study_id

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