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Status unknownNCT04449575Updated Apr 27, 2021

Hand Eczema in the Health Care Sector

An observational study in Hand Eczema, sponsored by University Hospital Bispebjerg and Frederiksberg. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hand Eczema

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03

In context

Eczema

1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 168 observational studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other skin diseases (in both groups)
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Health care workers with hand eczema

    Swabs will be taken from eczema lesions on dominating hand (if possible) and nostril

    Other: eSwabs

  • controls (health care workers without hand eczema)

    swabs will be taken from healthy skin on dominating hand and nostril

    Other: eSwabs

Interventions

  • OthereSwabs

    from skin

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What researchers measure

Primary outcomes

  1. Staphyloccous aureus presence

    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).

    Time frame: Baseline, cross-sectional

Secondary outcomes

  1. CC-types and spa-typing

    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).

    Time frame: Baseline, cross-sectional

  2. Hand Eczema Severity Index (HECSI)

    Validated severity measurement tool for hand eczema performed by the investigator. Severity will be correlated to S. aureus colonization and CC types

    Time frame: Baseline, cross-sectional

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Study locations

1 of 1 sites recruiting
  • Yasemin Topal Yüksel
    Copenhagen, Kbh Nv 2400, Denmark
    Recruiting
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References and documents

Publications

  • Mernelius S, Carlsson E, Henricson J, Lofgren S, Lindgren PE, Ehricht R, Monecke S, Matussek A, Anderson CD. Staphylococcus aureus colonization related to severity of hand eczema. Eur J Clin Microbiol Infect Dis. 2016 Aug;35(8):1355-61. doi: 10.1007/s10096-016-2672-2. Epub 2016 May 19. PubMed 27193891 ↗
  • Haslund P, Bangsgaard N, Jarlov JO, Skov L, Skov R, Agner T. Staphylococcus aureus and hand eczema severity. Br J Dermatol. 2009 Oct;161(4):772-7. doi: 10.1111/j.1365-2133.2009.09353.x. Epub 2009 Jul 3. PubMed 19575755 ↗
  • Pittet D, Allegranzi B, Sax H, Dharan S, Pessoa-Silva CL, Donaldson L, Boyce JM; WHO Global Patient Safety Challenge, World Alliance for Patient Safety. Evidence-based model for hand transmission during patient care and the role of improved practices. Lancet Infect Dis. 2006 Oct;6(10):641-52. doi: 10.1016/S1473-3099(06)70600-4. PubMed 17008173 ↗
  • Brans R, Kolomanski K, Mentzel F, Vollmer U, Kaup O, John SM. Colonisation with methicillin-resistant Staphylococcus aureus and associated factors among nurses with occupational skin diseases. Occup Environ Med. 2016 Oct;73(10):670-5. doi: 10.1136/oemed-2016-103632. Epub 2016 Jun 29. PubMed 27358469 ↗
  • Clausen ML, Edslev SM, Norreslet LB, Sorensen JA, Andersen PS, Agner T. Temporal variation of Staphylococcus aureus clonal complexes in atopic dermatitis: a follow-up study. Br J Dermatol. 2019 Jan;180(1):181-186. doi: 10.1111/bjd.17033. Epub 2018 Oct 10. PubMed 30070683 ↗
  • Held E, Skoet R, Johansen JD, Agner T. The hand eczema severity index (HECSI): a scoring system for clinical assessment of hand eczema. A study of inter- and intraobserver reliability. Br J Dermatol. 2005 Feb;152(2):302-7. doi: 10.1111/j.1365-2133.2004.06305.x. PubMed 15727643 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04449575
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Collaborators
Statens Serum Institut
Responsible party
Yasemin Topal Yüksel (MD, University Hospital Bispebjerg and Frederiksberg) — Principal investigator
First posted
Jun 29, 2020
Start date
Jul 1, 2020
Primary completion
Dec 2021 (estimated)
Completion
Jan 2022 (estimated)
Last update
Apr 27, 2021

Study contacts

Yasemin T. Yüksel, MD
Contact
yasemin.topal.yueksel@regionh.dk
004522917017
Tove Agner, MD, PhD
Contact
tove.agner@regionh.dk
Yasemin T. Yüksel, MD
principal investigator · University of Copenhagen Bispebjerg and Frederiksberg Hospital
Tove Agner, MD, PhD
study director · University of Copenhagen Bispebjerg and Frederiksberg Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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