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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040793
Receipt No. R000045823
Scientific Title Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/15

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Basic information
Public title Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Acronym Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title:Acronym Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Region
Japan

Condition
Condition Pediatric patients receiving laparoscopic surgery
Classification by specialty
Surgery in general Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An effect and the effectiveness of the Olanedine Antiseptic Solution for pediatric umbilical disinfection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The population and the number of bacteria after umbilical disinfection
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 1. a group of test agent with Olanedine
Interventions/Control_2 2. a group of control agent with Chlorhexidine Gluconate
Interventions/Control_3 3. a gruop of no agents
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
1 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria patients haveing operation with inguinal hernia, retentio testis and other minimally invasive surgery
Key exclusion criteria 1. patients with serious conditons
2. patients with emergency operation
3. Patients with exposure of mucous membrane at umbilicus
4. patients with redness or erosion at umbilicus
5. patients with drug allergy
6. patietns having inappropriate status for stusy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Obatake
Organization Kochi Medical School
Division name Surgery 1
Zip code 7838505
Address Kohasu, Okou, Nankoku, Kochi
TEL 0888802370
Email mobatake@kochi-u.ac.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Obatake
Organization Kochi Medical School
Division name Surgery 1
Zip code 7838505
Address Kohasu, Okou, Nankoku, Kochi
TEL 0888802370
Homepage URL
Email mobatake@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization No organization
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 Ethical Review Board of Kochi Medical School
Address Kohasu, Okou, Nankoku, Kochi
Tel 0888802180
Email rinri21@kochi-u.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
2020 Year 07 Month 15 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
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 06 Month 04 Day
Anticipated trial start date
2020 Year 06 Month 20 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 16 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045823

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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