UMIN-CTR Clinical Trial

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	30
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	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	2021 Year 05 Month 10 Day

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