UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045093 |
|---|---|
| Receipt number | R000051514 |
| Scientific Title | The level of skin injury depending on the way to remove medical film dressings: quantification of detached corneocytes |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/08/08 12:35:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The level of skin injury depending on the way to remove medical film dressings
Acronym
Skin injury during removal of film dressings
Scientific Title
The level of skin injury depending on the way to remove medical film dressings: quantification of detached corneocytes
Scientific Title:Acronym
quantification of detached corneocytes during removal of film dressings
Region
| Japan |
Condition
Condition
targeting healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The extent to which the epidermal keratin is damaged by the method of removing the medical film with a disinfectant will be compared and examined by the peeling angle mass for healthy subjects, and the peeling method that minimizes the damage of the keratin damage will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of total protein extracted from corneocytes attached to removed film dressings is compared depending on the ways of removal.
Key secondary outcomes
Profilaggrin level can be a target molecule reflecting detached immature corneocytes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Medical film dressings in a same size are attached to bilateral forearms of healthy volunteers. Thirty minutes later, the films are removed in different ways. Proteins of attached corneocytes to the films are extracted and quantified with the BCA assay.Intervention every 2 weeks for a total of 6 weeks
Interventions/Control_2
The procedures described above are performed on forearms with or without a single application of a topical moisturizer.
Interventions/Control_3
The procedures described in intervention 1 and 2 are performed using medical film dressings containing iodine.
There are four groups of intervention groups: differences in medical film peeling methods and moisturizer interventions, and differences in disinfectant film peeling methods and moisturizer interventions.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy medical professionals at the
Facility to which the principal investigator belongs who wish to participate
Key exclusion criteria
Those who are allergic to disinfectans
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ranko |
| Middle name | |
| Last name | Hinooka |
Organization
Asahikawa Medical University Hospital
Division name
Nursing Department
Zip code
078-8510
Address
Asahikawa City Midorigaoka Higashi 2-1
TEL
0166693604
hinooka@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Ranko |
| Middle name | |
| Last name | Hinooka |
Organization
Asahikawa Medical University Hospital
Division name
Nursing Department
Zip code
078-8510
Address
Asahikawa City Midorigaoka Higashi 2- 1
TEL
0166693604
Homepage URL
hinooka@asahikawa-med.ac.jp
Sponsor or person
Institute
Ministry of education
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Asahikawa Medical University Hospital
Address
Asahikawa City Midorigaoka Higashi 2-1
Tel
0166693604
hinooka@asahikawa-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
旭川医科大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 08 | Day |
Last modified on
| 2021 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051514
