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Workplace model for the oral exposure route

Workplace model for the oral exposure route - OMORE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038945
Enrollment
10
Registered
2026-01-15
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fraunhofer ITEM employees

Interventions

Group 1: Depending on their availability, participants can attend a minimum of two and a maximum of ten sessions. The first step is to examine the efficiency of sampling from the hand. Group 2: Next,

Sponsors

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Able and willing to give written informed consent. 2. Male and female subjects, aged 18 to 65 years. 3. Overall healthy as judged by the investigator 4. Employee of Fraunhofer ITEM

Exclusion criteria

Exclusion criteria: 1. Any facial skin lesions, hand skin lesion or oral mucosa lesions or dermatological diseases affecting the face or hands that in the opinion of the investigator might influence the outcome of this study. Any other disease that in the opinion of the investigator might influence the outcome of this study 2. Any concomitant medication that in the opinion of the investigator might influence the outcome of this study 3. Known allergy to model substance and latex. 4. Facial hair that might influence the outcome of the study. 5. Risk of non-compliance with study procedures 6. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study

Design outcomes

Primary

MeasureTime frame
The overall objective of the study is to implement standardised sampling methods to improve the recording of oral exposure in the workplace.

Secondary

MeasureTime frame
In order to achieve the overall objective, the following intermediate objectives must be achieved. 1) To determine the efficiency of sampling methods such as wiping to detect substance contamination on the skin (e.g. hands, perioral area) by determining the proportion of the target substance that is successfully transferred from the surface to the wipe during sampling. 2) Investigate the potential of saliva as a suitable body fluid for the (qualitative) assessment of oral exposure. 3) Determine the transfer of substances, e.g. from the surface to the hand and from the hand to the perioral area/mouth, in order to derive activity-related transfer factors for the model substance. 4) Generate data on oral exposure during simulated realistic work activities.

Countries

Germany

Contacts

Public ContactRamona Wellmann

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM

ramona.wellmann@item.fraunhofer.de+4951153508129

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026