UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003591 |
|---|---|
| Receipt number | R000004355 |
| Scientific Title | The establishment of the appropriate methods of antimicrobial prophylaxis for prevention of surgical site infection in spine surgeries |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2014/11/10 09:54:34 |
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Basic information
Public title
The establishment of the appropriate methods of antimicrobial prophylaxis for
prevention of surgical site infection in spine surgeries
Acronym
The establishment of the appropriate methods of antimicrobial prophylaxis for
prevention of SSI
Scientific Title
The establishment of the appropriate methods of antimicrobial prophylaxis for
prevention of surgical site infection in spine surgeries
Scientific Title:Acronym
The establishment of the appropriate methods of antimicrobial prophylaxis for
prevention of SSI
Region
| Japan |
Condition
Condition
Spinal disorders
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the preventive antimicrobial agent dispensing method of [shuujutsuki] of this department is effective to operate on the spine, and decides the best dispensing method in the spine operation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
White blood cells,and C-reactive Protein (CRP) v
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The antimicrobial agent is made cefazolin 1g (same as above) that is the first generation in the operation that doesn't use the implant by the ampicillin sodium 1.5g(amount once) that is a penicillin system antimicrobial agent in the operation that uses the implant. When the trap is administered, it is physiology brine solution 20 before the art when using it It mixes with ml, the vein is administered, and physiology brine solution 100 after the operation It mixes and the drip administering is done to ml.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Spinal surgery
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Uchio |
Organization
Shimane University
Division name
Orthopaedic Surgery
Zip code
Address
Izumo-shi Enya -cho 89-1
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University
Division name
Office
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic Surgery, Shimane University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Shimane University
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
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 10 | 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
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 10 | Day |
Last modified on
| 2014 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004355
