UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032519 |
|---|---|
| Receipt number | R000037085 |
| Scientific Title | Verification of preventive effect of Medical Device Related Pressure Ulcer by fixation of peripheral vascular indwelling catheter |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2024/11/22 12:07:09 |
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Basic information
Public title
Verification of preventive effect of Medical Device Related Pressure Ulcer by fixation of peripheral vascular indwelling catheter
Acronym
Verification of preventive effect of Medical Device Related Pressure Ulcer by fixation of peripheral vascular indwelling catheter
Scientific Title
Verification of preventive effect of Medical Device Related Pressure Ulcer by fixation of peripheral vascular indwelling catheter
Scientific Title:Acronym
Verification of preventive effect of Medical Device Related Pressure Ulcer by fixation of peripheral vascular indwelling catheter
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In fixing a peripheral vascular catheter to a patient , the catheter connecting portion is pressed and fixed to the skin, so that Medical Device Related Pressure Ulcer (MDRPU) occurs. Perform MDRPU prevention effect assessment by catheter fixation method.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In fixation of the peripheral vascular catheter, the result that the prevention effect of MDRPU of the two fixation methods is non-inferior is expected.The first fixation method is a fixation method using our existing cushion material "Meplex Transfer", the second fixation method is "Fix Kit-PV with cushion" that consists of Cushioning material and fixing material.
Key secondary outcomes
1.Fixing material attachment period
2.Reason for detachment of fixing material
3.Presence or absence of skin trouble at the evaluation site
4.Degree of skin trouble at the evaluation site
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To peripheral vascular catheterization patients, for Up to one week, carried a catheter fixing by "Fix Kit-PV with cushion" that consists of Cushioning material and fixing material.
Interventions/Control_2
To peripheral vascular catheterization patients, for Up to one week, carried a fixation method using our existing cushion material "Meplex Transfer".
Interventions/Control_3
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
| 25 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients hospitalized for cardiovascular medicine and Cardiovascular surgery scheduled to remain in peripheral venous catheter for 1 week or more.
2.Those who received a sufficient explanation about participation in this research from the research director, fully understand the contents thereof, and have consented to the document with free will.
Key exclusion criteria
1.Patients whose cognitive functions such as dementia have declined and which are difficult to make decisions
2.The patient's explanation due to the medical condition Patient who is difficult to agree
3.Patients with allergy to zinc
4.Patients who are extremely skin fragile
5.In addition, patients whose research managers judged inappropriate as research subjects
Target sample size
224
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Yokoyama |
Organization
Juntendo University Hospital
Division name
Department of Nursing
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
tyokoya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Yokoyama |
Organization
Juntendo University Hospital
Division name
Department of Nursing
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tyokoya@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037085
