UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028417
Receipt number R000032524
Scientific Title retrospective study of cases with mediastinitis and sternal osteomyelitis after thoracic aortic replacement using prosthetic graft.
Date of disclosure of the study information 2017/07/31
Last modified on 2018/07/30 08:41:05

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Basic information

Public title

retrospective study of cases with mediastinitis and sternal osteomyelitis after thoracic aortic replacement using prosthetic graft.

Acronym

postoperative research of deep sternal infection

Scientific Title

retrospective study of cases with mediastinitis and sternal osteomyelitis after thoracic aortic replacement using prosthetic graft.

Scientific Title:Acronym

postoperative research of deep sternal infection

Region

Japan


Condition

Condition

sternal osteomyelitis and mediastinitis

Classification by specialty

Cardiovascular surgery Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to verify the importance of early intervention by plastic surgeons and the effect of our new strategy for deep sternal infection after aortic replacement.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of prognosis of mediastinitis one year
after intervention

Key secondary outcomes

improvement of prognosis of sternal osteomyelitis one year after intervention


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the case who performed aortic replacement using prosthetic graft by median sternotomy approach in Aortic Center of Kawasaki Saiwai Hospital from 2012 to 2015.

Key exclusion criteria

Other approach, not aortic surgery, no-use of prosthetic graft

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motone Kuriyama

Organization

Kochi Medical School Hospital

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

Kohasu, Oko-cho, Nankoku, Kochi

TEL

088-880-2375

Email

jm-motone-k@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motone Kuriyama

Organization

Kochi Medical School Hospital

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

Kohasu, Oko-cho, Nankoku, Kochi

TEL

088-880-2375

Homepage URL


Email

jm-motone-k@kochi-u.ac.jp


Sponsor or person

Institute

Aortic Center of Kawasaki Saiwai 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


Address


Tel


Email



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

高知大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 31 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

We proved the effectiveness of early intervention and the improvement of prognosis one year after surgery.

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

2012 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded

2017 Year 07 Month 31 Day


Other

Other related information

We proved the effectiveness of early intervention and the improvement of prognosis one year after surgery.


Management information

Registered date

2017 Year 07 Month 27 Day

Last modified on

2018 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name