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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032579
Receipt No. R000037042
Scientific Title Investigation of bacterial detection rate of surgical site before and after surgery by disinfection method
Date of disclosure of the study information 2018/05/20
Last modified on 2019/05/14

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Basic information
Public title Investigation of bacterial detection rate of surgical site before and after surgery by disinfection method
Acronym Investigation of bacterial detection rate of surgical site by disinfection method
Scientific Title Investigation of bacterial detection rate of surgical site before and after surgery by disinfection method
Scientific Title:Acronym Investigation of bacterial detection rate of surgical site by disinfection method
Region
Japan

Condition
Condition Lumber canal stenosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine bacterial detection rate of surgical site before and after surgery by different disinfection methods to search for effective disinfection method against surgical site infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bacterial detection rate of surgical site before and after surgery by disinfection methods
Key secondary outcomes Surgical site infection rate within 3 months after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Use of alchol before using povidone iodine for surgical site before surgery
Interventions/Control_2 Use of povidone iodine for surgical site before surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with lumbar canal stenosis undergoing spinal decompression without instrumentation.
Key exclusion criteria 1)patients with allergy against alchol or povidone iodine.
2)emergency surgery
3)physician`s judgement
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yohei
Middle name
Last name Takahashi
Organization Fujita Health University
Division name Orthopedic Surgery
Zip code 470-1192
Address 1-98 Kutsukakecho, Denrakugakubo, Toyoake, Aichi
TEL 0562-93-2169
Email takahasiyohei@yahoo.co.jp

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Takahashi
Organization Fujita Health University
Division name Orthopedic Surgery
Zip code 470-1192
Address 1-98 Kutsukakecho, Denrakugakubo, Toyoake, Aichi
TEL 0562-93-2169
Homepage URL
Email takahasiyohei@yahoo.co.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health 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 Fujita Health University
Address 1-98 Kutsukakecho, Denrakugakubo, Toyoake, Aichi
Tel 0562932865
Email f-irb@fujita-hu.ac.jp

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
2018 Year 05 Month 20 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
2018 Year 01 Month 29 Day
Date of IRB
2018 Year 04 Month 24 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 13 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037042

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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