Hand EczemaNCT04449575
Hand Eczema in the Health Care Sector
An observational study of Hand Eczema, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Eczema
- What is being tested?
- eSwabs
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2020to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care workers from 4 hospitals in Capital Region, Denmark, with and without hand eczema.
Who may be able to join
- The diagnosis of hand eczema (for group with hand eczema)
Who cannot join
- Other skin diseases (in both groups)
Trial locations and contacts
1 site in 1 country.
Tove Agner, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Yasemin Topal Yüksel
Copenhagen, KBH NV, 2400
Yasemin Yüksel, MD, 22917017, y.topal@hotmail.com
About this study
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.
- Conditions
- Hand Eczema
- Being tested
- eSwabs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSwabsOther
from skin
| Study group | Role | What they receive |
|---|---|---|
| Health care workers with hand eczema | Swabs will be taken from eczema lesions on dominating hand (if possible) and nostril Receives: Other: eSwabs | |
| controls (health care workers without hand eczema) | swabs will be taken from healthy skin on dominating hand and nostril Receives: Other: eSwabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, cross-sectional
Secondary outcomes (2)
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).
Measured: Baseline, cross-sectional
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
Measured: Baseline, cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Jul 2020
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hand EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Principal investigator, Yasemin Topal Yüksel, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Yasemin T. Yüksel, MD, Principal investigator, University of Copenhagen Bispebjerg and Frederiksberg HospitalTove Agner, MD, PhD, Study director, University of Copenhagen Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449575
- Sponsor's protocol ID
- H20007169
- Status last verified
- Apr 2021
- First submitted
- 24 Jun 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27193891Haslund 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 19575755Pittet 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 17008173Brans 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 27358469Clausen 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 30070683Held 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Eczema in the Health Care Sector
- ClinicalTrials.gov ID
- NCT04449575
- Acronym / sponsor ID
- H20007169
- Conditions
- Hand Eczema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care workers with hand eczema | – | Other: eSwabsSwabs will be taken from eczema lesions on dominating hand (if possible) and nostril |
| controls (health care workers without hand eczema) | – | Other: eSwabsswabs will be taken from healthy skin on dominating hand and nostril |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers from 4 hospitals in Capital Region, Denmark, with and without hand eczema.
Key inclusion criteria (1 listed)
- The diagnosis of hand eczema (for group with hand eczema)
Key exclusion criteria (1 listed)
- Other skin diseases (in both groups)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSwabsfrom skin | Other | Health care workers with hand eczema, controls (health care workers without hand eczema) |
Primary outcome
Staphyloccous aureus presence
Time frame: Baseline, cross-sectional
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).
2 secondary outcomes
CC-types and spa-typing
Time frame: Baseline, cross-sectional
Hand Eczema Severity Index (HECSI)
Time frame: Baseline, cross-sectional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 27193891Mernelius 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.
- Background: PubMed 19575755Haslund 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.
- Background: PubMed 17008173Pittet 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.
- Background: PubMed 27358469Brans 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.
- Background: PubMed 30070683Clausen 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.
- Background: PubMed 15727643Held 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tove Agner, MD, PhD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Eczema, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin T. Yüksel, MD (004522917017, yasemin.topal.yueksel@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staphyloccous aureus presence (time frame: Baseline, cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449575, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.