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Clinical Trials/NCT04449575
NCT04449575UnknownNot Applicable

Hand Eczema in the Health Care Sector

University Hospital Bispebjerg and Frederiksberg1 site in 1 country300 target enrollmentStarted: July 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Staphyloccous aureus presence

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Other skin diseases (in both groups)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • CC-types and spa-typing(Baseline, cross-sectional)
  • Hand Eczema Severity Index (HECSI)(Baseline, cross-sectional)

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasemin Topal Yüksel

MD

University Hospital Bispebjerg and Frederiksberg

Study Sites (1)

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