UMIN-CTR Clinical Trial

Basic information
Public title	Appropriate use of Olanexidine gluconate in the gastrointestinal surgery
Acronym	Appropriate use of Olanexidine gluconate
Scientific Title	Appropriate use of Olanexidine gluconate in the gastrointestinal surgery
Scientific Title:Acronym	Appropriate use of Olanexidine gluconate
Region	Japan

Condition
Condition	Gastrointestinal disease
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify appropriate dose of olanedine solution antiseptic applicator in the gastrointestinal surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SSI incidence within 30 days after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One olanedine solution antiseptic applicator use at the time of skin disinfecting
Interventions/Control_2	Two olanedine solution antiseptic applicators use at the time of skin disinfecting
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	1)Patients undergoing laparotomy or laparoscopic or body surface surgery 2)Over 20 years old 3)Patients who understand the contents of the examination, and can observe it 4)Agreement from patients or subsutituted person
Key exclusion criteria	1)Patients who have some kind of opening wounds to skin 2)Stoma closer cases 3)Emergensy cases 4)Patients with skin disease such as atopic dermatitis, contact-related dermatitis, rash, hives 5)Patients who had an allergy to a study drug or gluconic acid chlorhexidine 6)Patients who are pregnant or have the probability of pregnancy 7)Patients who judged inappropriate cases
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name Yoshiyuki Middle name Last name Fujiwara
Organization	Tottori University Hospital
Division name	Gastrointestinal surgery
Zip code	683-8504
Address	36-1 Nishi-cho Yonago-shi
TEL	0859-38-6567
Email	y-fujiwara@med.tottori-u.ac.jp

Public contact
1st name of contact person	1st name Manabu Middle name Last name Yamamoto
Organization	Tottori University Hospital
Division name	Gastrointestinal surgery
Zip code	683-8504
Address	36-1 Nishi-cho Yonago-shi
TEL	0859-38-6567
Homepage URL
Email	m.yamamoto@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University Hospital
Institute
Department

Funding Source
Organization	Tottori University 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 Review Committee, Faculty of Medicine, Tottori University
Address	86 Nishi-cho, Yonago city, Tottori
Tel	0859386946
Email	crsc@med.tottori-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	2017 Year 05 Month 12 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	Completed
Date of protocol fixation	2017 Year 04 Month 30 Day
Date of IRB	2017 Year 04 Month 25 Day
Anticipated trial start date	2017 Year 05 Month 15 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 10 Month 05 Day
Date analysis concluded	2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 12 Day
Last modified on	2019 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030556