Hand Eczema in the Health Care Sector

April 26, 2021 updated by: Yasemin Topal Yüksel, University Hospital Bispebjerg and Frederiksberg
This project aims to investigate the prevalence of bacterial colonization and associated factors in health care workers with hand eczema with focus on Staphylococcus aureus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Two groups will be examined in this study: health care workers with HE and matched controls invited through a questionnaire study which will be sent to approximately 4000 health care workers in Capital Region. Samples from health care workers with and without hand eczema will be collected after obtaining their written informed consent. Collection of samples: Swabs will be rubbed on the skin for 30 seconds on lesional and non-lesional skin on the dominating hand and from the nostrils. The swabs will immediately be stored in -80 C° (research biobank) for subsequent analysis at Statens Serum Institute.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Kbh Nv
      • Copenhagen, Kbh Nv, Denmark, 2400
        • Recruiting
        • Yasemin Topal Yüksel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health care workers from 4 hospitals in Capital Region, Denmark, with and without hand eczema.

Description

Inclusion Criteria:

  • The diagnosis of hand eczema (for group with hand eczema)

Exclusion Criteria:

  • Other skin diseases (in both groups)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health care workers with hand eczema
Swabs will be taken from eczema lesions on dominating hand (if possible) and nostril
Other: eSwabs
from skin
controls (health care workers without hand eczema)
swabs will be taken from healthy skin on dominating hand and nostril
Other: eSwabs
from skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staphyloccous aureus presence
Time Frame: Baseline, cross-sectional
Prevalence of S. aureus colonization on hands and in nose in two groups of health care workers. The swab samples will be assessed by culturing on selective S. aureus plates (chromID S. aureus; bioMerieux, Marcy l'Etoile, France) and incubated overnight at 37 °C. DNA will be purified from S. aureus isolates using the Qiagen DNeasy Blood and Tissue Purification Kit (Qiagen, Hilden, Germany).
Baseline, cross-sectional

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CC-types and spa-typing
Time Frame: Baseline, cross-sectional
clonal complex (CC) type and spa-types are characterizing the S. aureus. Will be correlated to departments and professions of health care workers. The S. aureus will be further characterized by spa typing, which will be performed by polymerase chain reaction and Sanger sequencing of the product. The respective CC types will be assigned from the spa type using eBURST (http://eburst.mlst.net).
Baseline, cross-sectional
Hand Eczema Severity Index (HECSI)
Time Frame: Baseline, cross-sectional
Validated severity measurement tool for hand eczema performed by the investigator. Severity will be correlated to S. aureus colonization and CC types
Baseline, cross-sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Collaborators

Statens Serum Institut

Investigators

  • Principal Investigator: Yasemin T. Yüksel, MD, University of Copenhagen Bispebjerg and Frederiksberg Hospital
  • Study Director: Tove Agner, MD, PhD, University of Copenhagen Bispebjerg and Frederiksberg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (ACTUAL)

June 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20007169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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