UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040793 |
|---|---|
| Receipt number | R000045823 |
| Scientific Title | Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate |
| Date of disclosure of the study information | 2020/07/15 |
| Last modified on | 2021/05/10 14:20:28 |
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Basic information
Public title
Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Acronym
Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title
Exploratory research for preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title:Acronym
Exploratory research for 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
An effect and the effectiveness 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
The population and the number of bacteria after umbilical disinfection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
1. a group of test agent with Olanedine
Interventions/Control_2
2. a group of control agent with Chlorhexidine Gluconate
Interventions/Control_3
3. a gruop of no agents
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
patients haveing operation with inguinal hernia, retentio testis and other minimally invasive surgery
Key exclusion criteria
1. patients with serious conditons
2. patients with emergency operation
3. Patients with exposure of mucous membrane at umbilicus
4. patients with redness or erosion at umbilicus
5. patients with drug allergy
6. patietns having inappropriate status for stusy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Obatake |
Organization
Kochi Medical School
Division name
Surgery 1
Zip code
7838505
Address
Kohasu, Okou, Nankoku, Kochi
TEL
0888802370
mobatake@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Obatake |
Organization
Kochi Medical School
Division name
Surgery 1
Zip code
7838505
Address
Kohasu, Okou, Nankoku, Kochi
TEL
0888802370
Homepage URL
mobatake@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
No organization
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
Ethical Review Board of Kochi Medical School
Address
Kohasu, Okou, Nankoku, Kochi
Tel
0888802180
rinri21@kochi-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
| 2020 | Year | 07 | Month | 15 | 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
30
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
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045823
