Hand Eczema in the Health Care Sector

NCT ID: NCT04449575

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Hand Eczema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Health care workers with hand eczema

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

eSwabs

Intervention Type OTHER

from skin

controls (health care workers without hand eczema)

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

eSwabs

Intervention Type OTHER

from skin

Interventions

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eSwabs

from skin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other skin diseases (in both groups)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Statens Serum Institut

OTHER

Sponsor Role collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Topal Yüksel

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasemin T. Yüksel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen Bispebjerg and Frederiksberg Hospital

Tove Agner, MD, PhD

Role: STUDY_DIRECTOR

University of Copenhagen Bispebjerg and Frederiksberg Hospital

Locations

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Yasemin Topal Yüksel

Copenhagen, KBH NV, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Yasemin T. Yüksel, MD

Role: CONTACT

004522917017

Tove Agner, MD, PhD

Role: CONTACT

Facility Contacts

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Yasemin Yüksel, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27193891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19575755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17008173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27358469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30070683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15727643 (View on PubMed)

Other Identifiers

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H20007169

Identifier Type: -

Identifier Source: org_study_id

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