- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04136574
Hand Dermatitis in the Care and Hospital Staff (MANUS-PRO)
September 10, 2020 updated by: University Hospital, Brest
Hand Dermatitis in the Care and Hospital Staff of the Brest CHRU: State of Play
Study of the prevalence and risk factors of occupational dermatitis in the hands of caregivers and hospital staff of the Brest CHRU.
Study Overview
Status
Completed
Conditions
Detailed Description
Monocentric cross-sectional descriptive study by anonymous self-questionnaire designed to evaluate among caregivers and agents hospitals of the CHRU de Brest:
- the prevalence of occupational hands dermatitis
- the risk factors for hands dermatitis
- the clinical description of the hands dermatitis
- the rates of dermatitis according to hand hygiene practices (soap, hydro-alcoholic solution, associations of the two, wearing gloves ...)
- the changes in the hygiene practices of caregivers and hospital staff of the University Hospital caused by hand dermatitis.
- the professional and socio-economic impact of these hands dermatitis
- the evaluation of the use of care for these hands dermatitis.
- the assessment of the association of hand dermatitis with a personal or family atopic history.
Study Type
Observational
Enrollment (Actual)
1138
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brest, France, 29609
- CHRU Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Personal medical and paramedical caregivers and hospital staff working at the University Hospital ofBrest (any site confused).
This population therefore includes: doctors, midwives,nurses or specialized nurses, caregivers, hospital service officers, studentshealth, dentists, physiotherapists and other paramedical professions.
Description
Inclusion Criteria:
- Any caregiver, hospital staff or staff involved incare or stretchering of CHU patients returning tosocioprofessional categories cited in the questionnaire.
- Major person
- Participation Agreement
Exclusion Criteria:
- Minor person.
- Administrative Services Staff, Restaurant Staff,technical staff
- Refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of occupational hands dermatitis
Time Frame: Three months (at the end of study)
|
prevalence of occupational hands dermatitis among the staff of the Brest CHRU.
|
Three months (at the end of study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk Factors for Hand Dermatitis
Time Frame: Three months (at the end of study)
|
Risk Factors for Hand Dermatitis in Caregivers and Hospital Workers of the Brest Hospital
|
Three months (at the end of study)
|
Clinical description of the dermatitis of the hands
Time Frame: Three months (at the end of study)
|
Clinical description of the dermatitis of the hands of the caregivers and the hospital agents of the CHRU of Brest.
|
Three months (at the end of study)
|
rate of dermatitis according to the hygiene practices
Time Frame: Three months (at the end of study)
|
rate of dermatitis according to the hygiene practices of the hands (soap, SHA, combinations of both, wearing gloves ...)
|
Three months (at the end of study)
|
changes in hygiene practices
Time Frame: Three months (at the end of study)
|
changes in hygiene practices caregivers and hospital staff of the hospital induced by hands dermatitis
|
Three months (at the end of study)
|
Assessment of the professional and socio-economic impact of hand dermatitis
Time Frame: Three months (at the end of study)
|
Assessment of the professional and socio-economic impact of hand dermatitis in the care and hospital staff of the Hospital.
|
Three months (at the end of study)
|
Assessment of the use of care for these hand dermatitis
Time Frame: Three months (at the end of study)
|
Assessment of the use of care for these hand dermatitis
|
Three months (at the end of study)
|
atopic status
Time Frame: Three months (at the end of study)
|
atopic status
|
Three months (at the end of study)
|
Percentage, means, and standard deviations of responses to quantitative and qualitative questions that appeal to the primary and secondary objectives.
Time Frame: Three months (at the end of study)
|
Percentage, means, and standard deviations of responses to quantitative and
|
Three months (at the end of study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2019
Primary Completion (ACTUAL)
September 15, 2019
Study Completion (ACTUAL)
September 15, 2019
Study Registration Dates
First Submitted
August 5, 2019
First Submitted That Met QC Criteria
October 22, 2019
First Posted (ACTUAL)
October 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 11, 2020
Last Update Submitted That Met QC Criteria
September 10, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC19.0132
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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