UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037649 |
|---|---|
| Receipt number | R000042396 |
| Scientific Title | Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2020/07/15 10:33:25 |
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Basic information
Public title
Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate
Acronym
Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title
Evaluation of preoperative pediatric umbilical preparation using olanexidine gluconate
Scientific Title:Acronym
Evaluation of 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
Effect 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
Population and numberof bacteria after umbilical disinfection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control 20cases
Interventions/Control_2
Chlorhexidine Gluconate 20cases
Interventions/Control_3
Oranedine Gluconate 20cases
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
Pediatric patients receiving operation of inguinal hernia, retension testis or benign tumor resction
Key exclusion criteria
1 serious conditon
2 emergency operation
3 exposing mucosal membrane in the umblicum
4 dermatitis in the umblicum
5 drug allergy
6 other inadequate conditon
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Obatake |
| Middle name | |
| Last name | Masayuki |
Organization
Kochi Medical School Hospital
Division name
Surgery 1
Zip code
783-8505
Address
185-1 Kohasu Okou Nankoku Kochi
TEL
088-880-2370
mobatake@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Obatake |
| Middle name | |
| Last name | Masayuki |
Organization
Kochi Medical School Hospital
Division name
Surgery 1
Zip code
783-8505
Address
185-1 Kohasu Okou Nankoku Kochi
TEL
088-880-2370
Homepage URL
mobatake@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School 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 committee of Kochi Medical School
Address
185-1 Kohasu Okou Nankoku Kochi
Tel
088-866-5811
is21@kochi-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
ERB-105306
Org. issuing International ID_1
Ethics committee of Kochi Medical School
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042396
