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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025544
Receipt No. R000029404
Scientific Title Study of swab culture from surgical site in orthopaedic surgery
Date of disclosure of the study information 2017/01/31
Last modified on 2017/01/05

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Basic information
Public title Study of swab culture from surgical site in orthopaedic surgery
Acronym Swab culture in orthopaedic surgery
Scientific Title Study of swab culture from surgical site in orthopaedic surgery
Scientific Title:Acronym Swab culture in orthopaedic surgery
Region
Japan

Condition
Condition spinal diseases
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine bacterial flora on the surgical site in spinal surgery, and to evaluate the effect of antiseptic solution
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Swab culture positive rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 povidone-iodine
Interventions/Control_2 chlorhexidine-gluconate
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 Elective posterior spinal surgery
Key exclusion criteria Emergency surgery
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshitaka Yoshii
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedic Surgery
Zip code
Address Yushima1-5-45, Bunkyoku, Tokyo
TEL 03-5803-5279
Email yoshii.orth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshitaka Yoshii
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedic Surgery
Zip code
Address Yushima1-5-45, Bunkyoku, Tokyo
TEL 03-5803-5279
Homepage URL
Email yoshii.orth@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Other
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 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
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029404

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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