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
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
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
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
