UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032579
Receipt number 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 2019/12/13 01:32:42

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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 Shinjiro
Middle name
Last name Kaneko

Organization

Fujita Health University

Division name

Spine and Spinal Cord Surgery

Zip code

470-1192

Address

1-98 Kutsukakecho, Denrakugakubo, Toyoake, Aichi

TEL

0562-93-2169

Email

ShinjiroKaneko@gmail.com


Public contact

Name of contact person

1st name Shinjiro
Middle name
Last name Kaneko

Organization

Fujita Health University

Division name

Spine and Spinal Cord Surgery

Zip code

470-1192

Address

1-98 Kutsukakecho, Denrakugakubo, Toyoake, Aichi

TEL

0562-93-2169

Homepage URL


Email

ShinjiroKaneko@gmail.com


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



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 12 Month 13 Day



Link to view the page

Value
https://center6.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