UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study of usefulness of hydroxyapatite poly-L-lactide composite plate for prevention of sternal tear after sternotomy
Title of the study (Brief title)	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	Yoshikatsu Saiki
Organization	Tohoku University
Division name	Division of Cardiovascular Surgery
Address	1-1Seiryocho, Aoba-ku, Sendai
TEL	+81-22-717-7222
Email	yoshisaiki@med.tohoku.ac.jp

Public contact
Name of contact person	SHINGO TAKAHARA
Organization	Tohoku University
Division name	Division of Cardiovascular Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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