Hand Eczema in the Health Care Sector

Sponsor
University Hospital Bispebjerg and Frederiksberg (Other)
Overall Status
Recruiting
CT.gov ID
NCT04449575
Collaborator
Statens Serum Institut (Other)
300
1
18
16.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: eSwabs

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
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Hand Eczema in the Health Care Sector
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Staphyloccous aureus presence [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 Outcome Measures

  1. CC-types and spa-typing [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).

  2. Hand Eczema Severity Index (HECSI) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yasemin Topal Yüksel Copenhagen Kbh Nv Denmark 2400

Sponsors and Collaborators

  • University Hospital Bispebjerg and Frederiksberg
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yasemin Topal Yüksel, MD, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier:
NCT04449575
Other Study ID Numbers:
  • H20007169
First Posted:
Jun 29, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Apr 27, 2021