Hand Eczema in the Health Care Sector

Hand Eczema Clinical Trial

Official title:

Hand Eczema in the Health Care Sector

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449575
• Other study ID #: H20007169
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: January 2022

Study information

• Verified date: April 2021
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Yasemin T. Yüksel, MD
• Phone: 004522917017
• Email: yasemin.topal.yueksel[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Other skin diseases (in both groups)

Related Conditions & MeSH terms

• Eczema
• Hand Eczema

Intervention

Other:
• eSwabs
from skin

Locations

Country	Name	City	State
Denmark	Yasemin Topal Yüksel	Copenhagen	Kbh Nv

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

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. — View Citation

Clausen ML, Edslev SM, Nørreslet LB, Sørensen 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. — View Citation

Haslund P, Bangsgaard N, Jarløv 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. — View 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. — View Citation

Mernelius S, Carlsson E, Henricson J, Löfgren 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, cross-sectional
Secondary	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).	Baseline, cross-sectional
Secondary	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	Baseline, cross-sectional