UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029445
Receipt number 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 2023/04/10 09:12:15

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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 Yusuke
Middle name
Last name YAMAMOTO

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Department of Cardiovascular surgery

Zip code

183-8561

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 Yusuke
Middle name
Last name YAMAMOTO

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Department of Cardiovascular surgery

Zip code

183-8561

Address

Musasidai 2-8-29, Fuchu city, Tokyo, Japan

TEL

042-300-5111

Homepage URL


Email

acamais@gmail.com


Sponsor or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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

Tokyo Metropolitan Children's Medical Center

Address

Musashidai2-8-29, Fuchu-shi, Tokyo, Japan

Tel

042-300-5111

Email

acamais@gmail.com


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

Under reserch.

Number of participants that the trial has enrolled

7

Results

As above.

Results date posted

2023 Year 04 Month 10 Day

Results Delayed

Delay expected

Results Delay Reason

As above.

Date of the first journal publication of results


Baseline Characteristics

TBA

Participant flow

TBA

Adverse events

None for now.

Outcome measures

Not available

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Suspended

Date of protocol fixation

2017 Year 09 Month 30 Day

Date of IRB

2019 Year 03 Month 31 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

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

2023 Year 04 Month 10 Day



Link to view the page

Value
https://center6.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