UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012108 |
|---|---|
| Receipt number | 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 13:59:24 |
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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
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
haraga_i@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014152
