UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port
Title of the study (Brief title)	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	Kazuhisa Uchiyama
Organization	Osaka Medical College
Division name	General and Gastroenterological Surgery
Address	2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL	072-683-1221
Email	uchi@osaka-med.ac.jp

Public contact
Name of contact person	Ryo Tanaka
Organization	Osaka Medical College
Division name	General and Gastroenterological Surgery
Address	2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	sur148@osaka-med.ac.jp

Sponsor
Institute	Osaka medical college, General and Gastroenterological Surgery
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035654