UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027319 |
|---|---|
| Receipt number | 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 12:11:17 |
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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
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
m.yamamoto@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030556
