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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007207
Receipt No. R000008485
Scientific Title Investigation of Tegaderm Chlorhexidine Dressing for the Prevention of Catheter Associated Blood Stream Infection in Pediatric Intensive Care Units
Date of disclosure of the study information 2012/02/02
Last modified on 2012/02/02

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Basic information
Public title Investigation of Tegaderm Chlorhexidine Dressing for the Prevention of Catheter Associated Blood Stream Infection in Pediatric Intensive Care Units
Acronym Prevention of Catheter Associated Blood Stream Infection in Children
Scientific Title Investigation of Tegaderm Chlorhexidine Dressing for the Prevention of Catheter Associated Blood Stream Infection in Pediatric Intensive Care Units
Scientific Title:Acronym Prevention of Catheter Associated Blood Stream Infection in Children
Region
Japan

Condition
Condition Catheter Associated Blood Stream Infection
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of chlorhexidine dressing to decrease the incidence of catheter associated blood stream infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Decrease in the incidence of catheter associated blood stream infection
Key secondary outcomes

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 NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Chlorhexidine patch
Interventions/Control_2 Standard care
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
1 years-old <
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who required central venous catheter more than 7 days.
2. Patients who required to be admitted to Pediatric Intensive Care Unit.
Key exclusion criteria 1. History of allergy against chlorhexidine
2. Patients who do not require central venous catheter within 48 hours.
Target sample size 352

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Saitoh
Organization Niigata University Graduate School
Division name Pediatrics
Zip code
Address 1-757 Asahimachi-dori Chuo-ku Niigata
TEL 025-227-2222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Saitoh
Organization Niigata University Graduate School
Division name Pediatrics
Zip code
Address 1-757 Asahimachi-dori Chuo-ku Niigata
TEL 025-227-2222
Homepage URL
Email

Sponsor
Institute Niigata University Graduate School
Institute
Department

Funding Source
Organization 3M
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 新潟大学大学病院、国立成育医療研究センター、都立小児総合医療センター、長野こども病院、静岡こども病院

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 02 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 Open public recruiting
Date of protocol fixation
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2015 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 02 Day
Last modified on
2012 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008485

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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