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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012108
Receipt No. R000014152
Scientific Title A randomized comparative study of relation between reciprocal movement of internal jugular vein or epidural space catheter by sterilization procedure and catheter-related infection
Date of disclosure of the study information 2013/10/23
Last modified on 2013/10/23

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Basic information
Public title A randomized comparative study of relation between reciprocal movement of internal jugular vein or epidural space catheter by sterilization procedure and catheter-related infection
Acronym A randomized comparative study of relation between reciprocal movement of internal jugular vein or epidural space catheter by sterilization procedure and catheter-related infection
Scientific Title A randomized comparative study of relation between reciprocal movement of internal jugular vein or epidural space catheter by sterilization procedure and catheter-related infection
Scientific Title:Acronym A randomized comparative study of relation between reciprocal movement of internal jugular vein or epidural space catheter by sterilization procedure and catheter-related infection
Region
Japan

Condition
Condition Patients aged 20 years and older requiring a catheter insertion to internal jugular vein or epidural space for the perioperative treatment of pancreatic surgery
Classification by specialty
Medicine in general Infectious disease Surgery in general
Hepato-biliary-pancreatic surgery Anesthesiology Operative medicine
Emergency medicine Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the prevention effect for catheter-related infection by less reciprocal catheter movement at catheter sterilization procedure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Depth from the skin surface of the catheter to the bacterial growth point after 48 hours incubation on the culter medium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 2-times reciprocal sterilization procedure on the skin around the insertion site
Interventions/Control_2 4-times reciprocal sterilization procedure on the skin around the insertion site
Interventions/Control_3 6-times reciprocal sterilization procedure on the skin around the insertion site
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 Patients aged 20 years and older requiring a catheter insertion to internal jugular vein or epidural space for the perioperative treatment of pancreatic surgery
Key exclusion criteria 1. No written informed consent
2. Patients with skin disease at catheter insertion site
3. Patients with bacteremia at catheter puncture
4. Patients with bacterial infection at the other part, apart from catheter insertion site
5. Patients ineligible to the study based on investigator's decision
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Haraga
Organization Fukuoka University
Division name Department of Anesthesiology
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Email haraga_i@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Haraga
Organization Fukuoka University
Division name Department of Anesthesiology
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Homepage URL http://www.hop.fukuoka-u.ac.jp/rinshou/doctor/shounin.html
Email haraga_i@yahoo.co.jp

Sponsor
Institute Fukuoka University Department of Anesthesiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 福岡大学病院(福岡)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 23 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
2013 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 23 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
2013 Year 10 Month 23 Day
Last modified on
2013 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014152

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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