UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025588
Receipt No. 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

* 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 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
Email 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
Email takahara@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.