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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029445
Receipt No. R000033641
Scientific Title Clinical study of preventive effect of carboxymethyl cellulose(Sepra film) against adhesion formation after cardiac surgery.
Date of disclosure of the study information 2017/10/05
Last modified on 2019/04/07

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Basic information
Public title Clinical study of preventive effect of carboxymethyl cellulose(Sepra film) against adhesion formation after cardiac surgery.
Acronym Clinical study of preventive effect of carboxymethyl cellulose(Sepra film) against adhesion formation after cardiac surgery.
Scientific Title Clinical study of preventive effect of carboxymethyl cellulose(Sepra film) against adhesion formation after cardiac surgery.
Scientific Title:Acronym Clinical study of preventive effect of carboxymethyl cellulose(Sepra film) against adhesion formation after cardiac surgery.
Region
Japan

Condition
Condition Pediatric congenital heart disease
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate preventive effect of carboxymethyl cellulose sheet (Seprafilm) against the adhesion formation after pediatric cardiac surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total time needed for dissection of adhesion (= sum of following all items)
1. time from skin incision to sternum opened
2. time needed for dissection of pericardiac adhesion(befor CPB was commenced)
3. time needed for dissection of pericardiac adhesion(after CPB was commenced)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 .
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
1 days-old <=
Age-upper limit
2190 days-old >
Gender Male and Female
Key inclusion criteria -Patients who underwent main pulmonary artery banding operation as palliative procedure for future definitive repair.
-Patients who underwent Glenn operation as palliative procedure for future Fontan procedure.
Key exclusion criteria -Patients under unstable hemodynamic condition
-Patients carrying MRSA
-Patients who will have difficulty in chest closing after surgery
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke YAMAMOTO
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Cardiovascular surgery
Zip code
Address Musasidai 2-8-29, Fuchu city, Tokyo, Japan
TEL 042-300-5111
Email acamais@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke YAMAMOTO
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Cardiovascular surgery
Zip code
Address Musasidai 2-8-29, Fuchu city, Tokyo, Japan
TEL 042-300-5111
Homepage URL
Email acamais@gmail.com

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo metropolitan hospital fund for clinical research
Organization
Division
Category of Funding Organization Local Government
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 05 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information T.B.A.

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2019 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033641

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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