NCT04449575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

June 24, 2020

Last Update Submit

April 26, 2021

Conditions

Hand Eczema

Outcome Measures

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).

    Baseline, cross-sectional

Secondary Outcomes (2)

  • CC-types and spa-typing

    Baseline, cross-sectional

  • Hand Eczema Severity Index (HECSI)

    Baseline, cross-sectional

Study Arms (2)

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

eSwabsOTHER

from skin

Health care workers with hand eczemacontrols (health care workers without hand eczema)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Other skin diseases (in both groups)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin Topal Yüksel

Copenhagen, KBH NV, 2400, Denmark

RECRUITING

Related Publications (6)

  • 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.

    PMID: 27193891BACKGROUND

  • 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.

    PMID: 19575755BACKGROUND

  • 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.

    PMID: 17008173BACKGROUND

  • 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.

    PMID: 27358469BACKGROUND

  • 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.

    PMID: 30070683BACKGROUND

  • 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.

    PMID: 15727643BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bacteria from the skin will be sampled by eSwabs.

Study Officials

  • Yasemin T. Yüksel, MD

    University of Copenhagen Bispebjerg and Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

  • Tove Agner, MD, PhD

    University of Copenhagen Bispebjerg and Frederiksberg Hospital

    STUDY DIRECTOR

Central Study Contacts

Yasemin T. Yüksel, MD

CONTACT

004522917017yasemin.topal.yueksel@regionh.dk

Tove Agner, MD, PhD

CONTACT

tove.agner@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)