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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • Brest, France, 29609
        • CHRU Brest

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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