UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft
Title of the study (Brief title)	Usage of rifampicin-bonded gelatin-sealed Dacron graft
Region	Japan

Condition
Condition	infected aortic aneurysm, vascular graft infection
Classification by specialty	Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	anatomical reconstruction of artery after resection of infected aortic aneurysm or infected vascular graft
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical control of infection (imaging study and/or laboratory study)
Key secondary outcomes	patient death

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	gelatin-sealed Dacron graft is soaked in rifampicin solution before implantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) patients with infectious aortic aneurysm or vascular graft infection diagnosed by imaging study and/or laboratory study (2) patients with refractory to medical treatment
Key exclusion criteria	(1) patients with allergic for rifampicin (2) patients who refuse to the study
Target sample size	10

Research contact person
Name of lead principal investigator	Keiich Kanda
Organization	Kyoto Prefectural University of Medicine
Division name	Cardiovascular Surgery
Address	465 Kajii-cho, Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL	0752515752
Email	kei@koto.kpu-m.ac.jp

Public contact
Name of contact person	Keiich Kanda
Organization	Kyoto Prefectural University of Medicine
Division name	Cardiovascular Surgery
Address	465 Kajii-cho, Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL	0752515752
Homepage URL
Email	kei@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Cardiovascular Surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 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	2016 Year 05 Month 20 Day
Last modified on	2016 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025596