UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	retrospective study of cases with mediastinitis and sternal osteomyelitis after thoracic aortic replacement using prosthetic graft.
Title of the study (Brief title)	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	Motone Kuriyama
Organization	Kochi Medical School Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2375
Email	jm-motone-k@kochi-u.ac.jp

Public contact
Name of contact person	Motone Kuriyama
Organization	Kochi Medical School Hospital
Division name	Department of Plastic and Reconstructive Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We proved the effectiveness of early intervention and the improvement of prognosis one year after surgery.
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/icdr_e/ctr_view.cgi?recptno=R000032524