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 2021/05/24 18:12:22

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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

Email

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


Email

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

Email

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

Enrolling by invitation

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

2021 Year 05 Month 24 Day



Link to view the page

Value
https://center6.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