UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017357 |
|---|---|
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy
Acronym
sternal pins
Scientific Title
Evaluation of effectiveness of sternal pins for prevention of gaps and pains after sternotomy
Scientific Title:Acronym
sternal pins
Region
| Japan |
Condition
Condition
initial sternotomy
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of sternal pins (Granfix) for prevention of gaps and pains after initial sternotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gaps of sternum measured with post-operative 3D-CT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
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.
Interventions/Control_2
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.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the cases which will be made sternotomy at first time
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University graduate school of medicine
Division name
Cardiovascular surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7222
dr_takashin@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | To whom it may concern |
Organization
Tohoku University Hospital
Division name
CRIETO
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-728-4105
Homepage URL
http://www.med.tohoku.ac.jp/public/rinri_s.html
rinri-2@proj.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University graduate school of medicine
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 30 | 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
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
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2018 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
