Unique ID issued by UMIN | UMIN000017357 |
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Receipt number | R000020141 |
Scientific Title | Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy |
Date of disclosure of the study information | 2015/04/30 |
Last modified on | 2018/02/21 12:03:09 |
Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy
sternal pins
Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy
sternal pins
Japan |
initial sternotomy
Cardiovascular surgery | Adult |
Others
NO
To evaluate the effectiveness of sternal pins (Granfix) for prevention of gaps and pains after initial sternotomy.
Efficacy
Gaps of sternum measured with post-operative 3D-CT
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
2
Prevention
Device,equipment |
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.
20 | years-old | <= |
80 | years-old | > |
Male and Female
the cases which will be made sternotomy at first time
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
100
1st name | |
Middle name | |
Last name | Yoshikatsu Saiki |
Tohoku University graduate school of medicine
Cardiovascular surgery
1-1 Seiryo-machi, Aoba-ku, Sendai
022-717-7222
dr_takashin@hotmail.com
1st name | |
Middle name | |
Last name | To whom it may concern |
Tohoku University Hospital
CRIETO
1-1 Seiryo-machi, Aoba-ku, Sendai
022-728-4105
http://www.med.tohoku.ac.jp/public/rinri_s.html
rinri-2@proj.med.tohoku.ac.jp
Tohoku University graduate school of medicine
Tohoku University graduate school of medicine
Other
NO
2015 | Year | 04 | Month | 30 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 30 | Day |
2013 | Year | 09 | Month | 30 | Day |
2015 | Year | 04 | Month | 30 | Day |
2018 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020141
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