UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025763 |
|---|---|
| Receipt number | R000028502 |
| Scientific Title | Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2022/07/26 10:06:47 |
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Basic information
Public title
Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery
Acronym
New sternal fixation device study
Scientific Title
Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery
Scientific Title:Acronym
New sternal fixation device study
Region
| Japan |
Condition
Condition
Patients who undergo cardiovascular surgery with full sternotomy
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative displacement of sternal halves with new sternal fixation device to that with simple wire cerclage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Displacement of sternal halves (CT scan): 6 months after surgery
Key secondary outcomes
Displacement of sternal halves (CT scan): 2weeks and 3 months after surgery
Dihisecnce, Bone union, and CBDA; Cortical bone density area (CT scan): 2weeks, 3months, and 6months after surgery
Sternal infection and Pain score: 1week, 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery
Quality of Life: 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sternal closure with new sternal fixation device, which is inserted in bone marrow, followed by wire cerclage
Interventions/Control_2
Sternal closure with simple wire cerclage
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20 years of age and more
Key exclusion criteria
Emergency, Diabetes (HbA1c is 8.0% and more), Hemodialysis, Steroid, Immunosuppressant, Severe COPD, Ventricular assist device, Infectious endocarditis, and Pacemaker lead infection
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hirokuni |
| Middle name | |
| Last name | Arai |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, JAPAN
TEL
03-5803-5267
hiro.cvsg@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kiyotoshi |
| Middle name | |
| Last name | Oishi |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, JAPAN
TEL
03-5803-5270
Homepage URL
oishi.cvsg@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical And Dental University, University Hospital of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teijin Medical Technology Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital of Medicine, Clinical Reserch Center
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, JAPAN
Tel
03-5803-5612
tiken.crc@tmd.ac.jp
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
東京医科歯科大学医学部附属病院（東京都）
武蔵野赤十字病院（東京都）
青梅市立総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 24 | 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
70
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under review
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
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028502
