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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028417
Receipt No. 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

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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
Institute Aortic Center of Kawasaki Saiwai Hospital
Institute
Department

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
URL(English) https://upload.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


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