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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000017357 |
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Date of registration:
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30/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy
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Scientific title:
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Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy - sternal pins |
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Date of first enrolment:
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2013/09/30 |
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Target sample size:
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100 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020141 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yoshikatsu Saiki |
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Address:
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1-1 Seiryo-machi, Aoba-ku, Sendai
Japan |
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Telephone:
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022-717-7222 |
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Email:
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dr_takashin@hotmail.com |
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Affiliation:
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Tohoku University graduate school of medicine Cardiovascular surgery |
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Name:
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To whom it may concern |
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Address:
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1-1 Seiryo-machi, Aoba-ku, Sendai
Japan |
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Telephone:
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022-728-4105 |
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Email:
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rinri-2@proj.med.tohoku.ac.jp |
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Affiliation:
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Tohoku University Hospital CRIETO |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: age: under 19, over 80 year-old Patients who undergo hemodialysis Patients who have allergy to PLLA Patients who have used analgesic drugs Paitents who want sternal pins used Patients who deny the informed consent Patients who are not eligble
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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initial sternotomy
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Intervention(s)
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sternal pin(-) group: Sternums of all patients will be closed with 6 stenless wires alone. The upper 2 wires should pierce the sternal manubrium and the lower 4 wires should pierce the sternal body. They should be twisted tightly.
sternal pin(+) group: The sternums should be closed as mentioned above. Additionally 2 sternal pins (Granfix) should be inserted into bone barrow; one between the 1st and 2nd wire, and the other between the 4th and 5th wire.
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Primary Outcome(s)
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Gaps of sternum measured with post-operative 3D-CT
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Source(s) of Monetary Support
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Tohoku University graduate school of medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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