Clinical trial NCT04449575: Hand Eczema in the Health Care Sector
Official title: Hand Eczema in the Health Care Sector
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand Eczema
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
First posted: 2020-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers from 4 hospitals in Capital Region, Denmark, with and without hand eczema.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other skin diseases (in both groups)

Primary outcomes:
measure: Staphyloccous aureus presence
timeFrame: Baseline, cross-sectional
Secondary outcomes:
measure: CC-types and spa-typing
timeFrame: Baseline, cross-sectional
measure: Hand Eczema Severity Index (HECSI)
timeFrame: Baseline, cross-sectional
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Yasemin Topal Yüksel
state: Kbh Nv
Study officials:
affiliation: University of Copenhagen Bispebjerg and Frederiksberg Hospital
name: Yasemin T. Yüksel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen Bispebjerg and Frederiksberg Hospital
name: Tove Agner, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.