Hand Eczema in the Health Care Sector

• Conditions: Hand Eczema
• Interventions: Other: eSwabs

• Registration Number: NCT04449575
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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 Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Study Start: 2020-07-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-12
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Other skin diseases (in both groups)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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

Trial Locations

Locations (1)

Yasemin Topal Yüksel; 🇩🇰 Copenhagen, Kbh Nv, Denmark