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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032519
Receipt No. 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 2018/07/04

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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
Middle name
Last name Tomomi Yokoyama
Organization Juntendo University Hospital
Division name Department of Nursing
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email tyokoya@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Yokoyama
Organization Juntendo University Hospital
Division name Department of Nursing
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email tyokoya@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
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
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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