UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate
Acronym	Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title	Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title:Acronym	Evaluation of 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	Effect 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	Population and numberof bacteria after umbilical disinfection
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Control 20cases
Interventions/Control_2	Chlorhexidine Gluconate 20cases
Interventions/Control_3	Oranedine Gluconate 20cases
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	Pediatric patients receiving operation of inguinal hernia, retension testis or benign tumor resction
Key exclusion criteria	1 serious conditon 2 emergency operation 3 exposing mucosal membrane in the umblicum 4 dermatitis in the umblicum 5 drug allergy 6 other inadequate conditon
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Obatake Middle name Last name Masayuki
Organization	Kochi Medical School Hospital
Division name	Surgery 1
Zip code	783-8505
Address	185-1 Kohasu Okou Nankoku Kochi
TEL	088-880-2370
Email	mobatake@kochi-u.ac.jp

Public contact
Name of contact person	1st name Obatake Middle name Last name Masayuki
Organization	Kochi Medical School Hospital
Division name	Surgery 1
Zip code	783-8505
Address	185-1 Kohasu Okou Nankoku Kochi
TEL	088-880-2370
Homepage URL
Email	mobatake@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School Hospital
Institute
Department

Funding Source
Organization	Kochi Medical School Hospital
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	Ethics committee of Kochi Medical School
Address	185-1 Kohasu Okou Nankoku Kochi
Tel	088-866-5811
Email	is21@kochi-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	ERB-105306
Org. issuing International ID_1	Ethics committee of Kochi Medical School
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 13 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	Terminated
Date of protocol fixation	2019 Year 06 Month 25 Day
Date of IRB	2019 Year 08 Month 01 Day
Anticipated trial start date	2019 Year 08 Month 09 Day
Last follow-up date	2020 Year 08 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 09 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=R000042396