UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031345 |
|---|---|
| Receipt number | R000035654 |
| Scientific Title | Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port |
| Date of disclosure of the study information | 2018/02/17 |
| Last modified on | 2018/02/17 07:25:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port
Acronym
Randomized controlled trial on prophylactic antibiotic administration in totally implantable central venous port
Scientific Title
Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port
Scientific Title:Acronym
Randomized controlled trial on prophylactic antibiotic administration in totally implantable central venous port
Region
| Japan |
Condition
Condition
Case of totally implantable central venous port
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the appropriate use of prophylactic antibiotics administration in totally implantable central venous port
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Incidence of surgical site infection within 30 days after totally implantable central venous port
Key secondary outcomes
Incidence of totally infectious complications within 30 days after totally implantable central venous port
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 1g of cefazolin before and after surgery
Interventions/Control_2
Omission of prophylactic antibiotics administration
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 with elective totally implantable central venous port
2) No previous chemotherapy or radiation
3) Fulfil all following conditions
WBC > 3,000/mm3
Plt > 100,000/mm3
AST < 100 IU/L
ALT < 100IU/L
T.Bil < 2.0 g/dl
Cre < 1.5mg/dl
4) written informed consent
Key exclusion criteria
1) Having active infectious disease
2) With uncontrolled diabetes mellitus
3) With myelosuppression due to immunodeficiency or chemotherapy history
4) With short bowel syndrome
5) With allergy to cephalosporin
6) Patient judged inappropriate by the attending physician
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka Medical College
Division name
General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL
072-683-1221
uchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Osaka Medical College
Division name
General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL
072-683-1221
Homepage URL
sur148@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college, General and Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪医科大学 一般・消化器外科
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035654
