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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027319
Receipt No. R000030556
Scientific Title Appropriate use of Olanexidine gluconate in the gastrointestinal surgery
Date of disclosure of the study information 2017/05/12
Last modified on 2019/05/16

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000030556

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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