UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025588 |
|---|---|
| Receipt number | R000029411 |
| Scientific Title | Pilot study of usefulness of hydroxyapatite poly-L-lactide composite plate for prevention of sternal tear after sternotomy |
| Date of disclosure of the study information | 2017/01/13 |
| Last modified on | 2017/11/26 22:09:44 |
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Basic information
Public title
Pilot study of usefulness of hydroxyapatite poly-L-lactide composite plate for prevention of sternal tear after sternotomy
Acronym
Pilot study - HA/PLLA plate for sternal tear
Scientific Title
Pilot study of usefulness of hydroxyapatite poly-L-lactide composite plate for prevention of sternal tear after sternotomy
Scientific Title:Acronym
Pilot study - HA/PLLA plate for sternal tear
Region
| Japan |
Condition
Condition
sternal tear after sternotomy
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To garner data for planning subsequent RCT of which purpose is to evaluate the usefulness of HA/PLLA plate for prevention of sternal tear after sternotomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of sternal tear
Key secondary outcomes
Instability of sternum
Pain
Post-operative bleeding
Safety-Infection, allegic reaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After cardiac surgery through median sternotomy, HA/PLLA plate will be placed between sternum and sternal wires.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who will undergo the initial sternotomy
Key exclusion criteria
Patient
-who has previously undergone sternotomy
-who has been administered an analgesic drug regularly
-who needs hemodialysis
-whose bilateral internal thoracic arteries will be harvested as bypass grafts
-who participates in any other clinical trials
-who has active infectious diseases
-who is in immunosuppressive state
-who has uncontrollable diabete mellitus
-who has allergy to this material
-who is pregnant or possibly pregnant, or whithin 28 days after delivery, or under lactation
-who has mental disease in which he or she cannot precisely evaluate their symptoms by therselve
-whom medical doctor evaluate impossible to take part in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University
Division name
Division of Cardiovascular Surgery
Zip code
Address
1-1Seiryocho, Aoba-ku, Sendai
TEL
+81-22-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SHINGO TAKAHARA |
Organization
Tohoku University
Division name
Division of Cardiovascular Surgery
Zip code
Address
1-1 Seiryocho, Aobaku, Sendai
TEL
+81-22-717-7222
Homepage URL
takahara@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Division of Cardiovascular Surgery
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
東北大学病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 13 | 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
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 11 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2017 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029411
