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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030033
Receipt No. R000034296
Scientific Title The effect of the negative pressure wound therapy for the peritoneal dialysis catheter exit site
Date of disclosure of the study information 2017/11/19
Last modified on 2019/05/31

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Basic information
Public title The effect of the negative pressure wound therapy for the peritoneal dialysis catheter exit site
Acronym The effect of the negative pressure wound therapy for the peritoneal dialysis catheter exit site
Scientific Title The effect of the negative pressure wound therapy for the peritoneal dialysis catheter exit site
Scientific Title:Acronym The effect of the negative pressure wound therapy for the peritoneal dialysis catheter exit site
Region
Japan

Condition
Condition end stage renal disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analysis the effect of the negative pressure wound therapy for the peritoneal dialysis catheter exit site
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The infection rate of the peritonitis or the catheter-related infections
Key secondary outcomes

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Negative pressure wound therapy (7 days)
Interventions/Control_2 Standard therapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Newly initiated peritoneal dialysis patients
2) Age >=20 years old
3) Patients with written IC
Key exclusion criteria 1) Patient without written IC
2) Age <20 years old
3) Ineligible patients according to the investigator's judgment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Junichiro
Middle name
Last name Nakata
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code 113-8421
Address 2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL +81-3-5802-1065
Email jnakata@juntendo.ac.jp

Public contact
Name of contact person
1st name Junichiro
Middle name
Last name Nakata
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code 113-8421
Address 2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL +81-3-5802-1065
Homepage URL
Email jnakata@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hospital Ethics Committee Juntendo University Hospital
Address 3-1-3 Hongo Bunkyo-ku, Tokyo, Japan
Tel +81-3-5802-1584
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
2017 Year 11 Month 19 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
2017 Year 11 Month 15 Day
Date of IRB
2017 Year 11 Month 15 Day
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
2021 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
2017 Year 11 Month 19 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034296

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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