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
CRIS Registration Number |
KCT0005829 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | 202012D08 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | High-risk ulcer patients who visit Severance Hospital |
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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)
Type of Primary Outcome | Bio-availability | |
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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) |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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