UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children
Title of the study (Brief title)	Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children
Region	Japan

Condition
Condition	Patients who undergo surgery of catheter insertion or inguinal hernia
Classification by specialty	Surgery in general Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was designed to measure the safety and the efficacy of a new antiseptic Olanexidine gluconate in children.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcome was determined to assess the rate of any adverse effect such as labo data, vital sign, subjective and objective symptom, erythema or irritation of the skin.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	An applicator of 1.5% Olamexidine gluconate is used at surgical site. The skin site exposed to 1.5% Olamexidine gluconate are inspected daily by the bed side nursse or physician to assess any adverse effect such as labo data, vital sign, subjective and objective symptom, erythema or irritation of the skin. Blood concentration of 1.5% Olamexidine gluconate was measured at 0, 2, 24 hours after surgery to draw AUC curve in patients with catheter insertion.
Interventions/Control_2
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	1 years-old <=
Age-upper limit	16 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Children who undergo surgery for catheter insertion or inguinal hernia from 1 to 16 years of age. (2)No abnormal appearance of the skin for surgical incision. (3)Informed concent was obtained from guardians.
Key exclusion criteria	(1)History of drug sensitivity. (2)History of shock or hypersensitivity against Chlorhexidine gluconate. (3)Patients having cutaneous disease (4)Any patients who was judged as inappropriate candidate to enroll this study
Target sample size	55

Research contact person
Name of lead principal investigator	Toshihiko Watanabe
Organization	National Center for Child Health and Development
Division name	Division of Surgery
Address	2-10-1 Okura,Setagaya-ku, Tokyo 157-8535
TEL	03-3416-0181
Email	watanabe-ts@ncchd.go.jp

Public contact
Name of contact person	Kyoko Hagino
Organization	National Center for Child Health and Development
Division name	Division of Medical Research
Address	2-10-1 Okura,Setagaya-ku, Tokyo 157-8535
TEL	03-3416-0181
Homepage URL
Email	hagino-k@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 06 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
Anticipated trial start date	2017 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 23 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031937