Hand DermatosesMANUS-PRONCT04136574
Hand Dermatitis in the Care and Hospital Staff
An observational study of Hand Dermatoses, run by University Hospital, Brest at 1 site in France.
Trial summary
Study of the prevalence and risk factors of occupational dermatitis in the hands of caregivers and hospital staff of the Brest CHRU. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Dermatoses
- How many people
- 1,138 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 15 Sep 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Any caregiver, hospital staff or staff involved incare or stretchering of CHU patients returning tosocioprofessional categories cited in the questionnaire.
- Major person
- Participation Agreement
Who cannot join
- Minor person.
- Administrative Services Staff, Restaurant Staff,technical staff
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Dermatoses
- Keywords
- hand dermatoses, hand dermatitis, occupationnal, caregivers, hand hygiene
- Medical subject headings
- Hand Dermatoses
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of occupational hands dermatitis
prevalence of occupational hands dermatitis among the staff of the Brest CHRU.
Measured: Three months (at the end of study)
Secondary outcomes (8)
Risk Factors for Hand Dermatitis
Risk Factors for Hand Dermatitis in Caregivers and Hospital Workers of the Brest Hospital
Measured: Three months (at the end of study)
Clinical description of the dermatitis of the hands
Clinical description of the dermatitis of the hands of the caregivers and the hospital agents of the CHRU of Brest.
Measured: Three months (at the end of study)
rate of dermatitis according to the hygiene practices
rate of dermatitis according to the hygiene practices of the hands (soap, SHA, combinations of both, wearing gloves ...)
Measured: Three months (at the end of study)
changes in hygiene practices
changes in hygiene practices caregivers and hospital staff of the hospital induced by hands dermatitis
Measured: Three months (at the end of study)
Assessment of the professional and socio-economic impact of hand dermatitis
Assessment of the professional and socio-economic impact of hand dermatitis in the care and hospital staff of the Hospital.
Measured: Three months (at the end of study)
Assessment of the use of care for these hand dermatitis
Assessment of the use of care for these hand dermatitis
Measured: Three months (at the end of study)
atopic status
atopic status
Measured: 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.
Percentage, means, and standard deviations of responses to quantitative and
Measured: Three months (at the end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Jul 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DermatosesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136574
- Sponsor's protocol ID
- 29BRC19.0132
- Acronym
- MANUS-PRO
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Dermatitis in the Care and Hospital Staff of the Brest CHRU: State of Play
- ClinicalTrials.gov ID
- NCT04136574
- Acronym / sponsor ID
- MANUS-PRO / 29BRC19.0132
- Conditions
- Hand Dermatoses
- Keywords
- hand dermatoses, hand dermatitis, occupationnal, caregivers, hand hygiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,138 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 23 Oct 2019 (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.
Study of the prevalence and risk factors of occupational dermatitis in the hands of caregivers and hospital staff of the Brest CHRU.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Any caregiver, hospital staff or staff involved incare or stretchering of CHU patients returning tosocioprofessional categories cited in the questionnaire.
- Major person
- Participation Agreement
Key exclusion criteria (3 listed)
- Minor person.
- Administrative Services Staff, Restaurant Staff,technical staff
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Risk Factors for Hand Dermatitis
Time frame: Three months (at the end of study)
Clinical description of the dermatitis of the hands
Time frame: Three months (at the end of study)
rate of dermatitis according to the hygiene practices
Time frame: Three months (at the end of study)
changes in hygiene practices
Time frame: 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 use of care for these hand dermatitis
Time frame: Three months (at the end of study)
atopic status
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Related trials for Hand Dermatoses
Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
Not yet recruitingEarly Phase 1
Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial
Systemic Sclerosis, Sclerodactyly
Not yet recruiting
Using AI-Assisted Cameras to Track Hand Exercises in Scleroderma Patients
Systemic Scleroderma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dermatoses, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Sep 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of occupational hands dermatitis (time frame: Three months (at the end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2020.