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Research on monitoring technique of pressure ulcer patients to develop wearable sensors for prevention of decubitus ulcer

Status Approved

  • First Submitted Date

    2021/01/20

  • Registered Date

    2021/01/27

  • Last Updated Date

    2021/01/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005829
    Unique Protocol ID 4-2020-0995
    Public/Brief Title Research on monitoring technique of pressure ulcer patients to develop wearable sensors for prevention of decubitus ulcer
    Scientific Title Research on monitoring technique of pressure ulcer patients to develop wearable sensors for prevention of decubitus ulcer
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2020-0995
    Approval Date 2020-10-18
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Institutional Review Board Telephone 02-2228-0454
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Ju Hee Lee
    Title Professor
    Telephone +82-2-2228-2080
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name Ju Hee Lee
    Title professor
    Telephone +82-2-2228-2080
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name Ju Hee Lee
    Title professor
    Telephone +82-2-2228-2080
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-01-14 Actual
    Target Number of Participant 20
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-01-14 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID 202012D08
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    In high-risk patients with pressure ulcers, a non-invasive measurement method is used to evaluate the indicators of skin changes in the area where pressure ulcers occur, and to derive the correlation between the measurement results, to establish a database of skin measurement indexes for patients with bedsores. The usefulness and necessity of the study will be explained to test subjects calculated based on the selection criteria and exclusion criteria, and test subjects will be recruited. If selected as a test subject, fill out the consent form and measure the temperature, color, erythema, and elasticity of the subject's normal skin area using non-invasive skin measurement equipment at the site of high risk of pressure ulcers in the Severance Hospital Dermatology Department I will compare and measure. Subjects visited the hospital twice at intervals of one month to conduct measurement.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 20
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    High risk ulcer patients

    Cohort/Group Description

    Patients with pressure ulcers in areas that are clinically vulnerable to pressure (tailbone, hip, scapula, heel, occipital region, etc.), and grade II or less in EPUAP ulcer grading
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    High-risk ulcer patients who visit Severance Hospital
    Sampling Method
    1) Patients with pressure ulcers in areas that are clinically vulnerable to pressure (tail bone, hip, scapula, heel, occipital region, etc.) and who are below grade II in EPUAP ulcer grading
    2) Those who are at risk of limited behavior due to one of the following predictors that may develop and worsen bedsores
    -70 years of age or older
    -Current smoking history
    -Low body mass index and malnutrition
    -History of bedsores
    -Dry and flaky skin
    -Underlying disease (degenerative neurological disease, cerebrovascular disease, cerebrospinal cord injury, cancer, diabetes, heart failure, etc.)
    3) A person who voluntarily agrees to this study and writes a consent form after IRB approval
    4) Those who can visit the hospital outpatient clinic (use a wheelchair) and follow-up during the test period
    5) Men and women who are 19 years of age or older who can provide a legally valid consent form
    Condition(s)/Problem(s) * (L00-L99)Diseases of the skin and subcutaneous tissue 
       (L89.9)Decubitus ulcer and pressure area, unspecified 

    pressure sore
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1) Patients with pressure ulcers in areas that are clinically vulnerable to pressure (tail bone, hip, scapula, heel, occipital region, etc.) and who are below grade II in EPUAP ulcer grading
    2) Those who are at risk of limited behavior due to one of the following predictors that may develop and worsen bedsores
    -70 years of age or older
    -Current smoking history
    -Low body mass index and malnutrition
    -History of bedsores
    -Dry and flaky skin
    -Underlying disease (degenerative neurological disease, cerebrovascular disease, cerebrospinal cord injury, cancer, diabetes, heart failure, etc.)
    3) A person who voluntarily agrees to this study and writes a consent form after IRB approval
    4) Those who can visit the hospital outpatient clinic (use a wheelchair) and follow-up during the test period
    5) Men and women who are 19 years of age or older who can provide a legally valid consent form
    Exclusion Criteria
    1) Patients with systemic conditions accompanied by instability of vital signs such as infection or organ failure
    2) Persons with findings accompanied by a local infection of the pressure sore
    3) Persons with skin diseases (atopic dermatitis, contact dermatitis, psoriasis, etc.) that may affect the examination findings
    4) A person who has not voluntarily agreed to this study after IRB approval and did not fill out a consent form
    5) Vulnerable test subjects (pregnant women, newborns, minors, persons in prison, military personnel, employees of the research director, etc.)
    6) Subjects who cannot read and understand the consent form (illiteracy, etc.)
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Bio-availability
    Primary Outcome(s) 1
    Outcome
    Measurement values ​​of skin temperature, color, and erythema degree measured through thermal imaging camera, 3D camera, and Mexameter
    Timepoint
    visit 0, visit 1 (1 month follow-up)
    Secondary Outcome(s) 1
    Outcome
    Measurement value of skin elasticity measured by cutometer
    Timepoint
    visit 0, visit 1 (1 month follow-up)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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