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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032964
Receipt No. R000037591
Official scientific title of the study Skin tension of scalp in infants
Date of disclosure of the study information 2018/06/14
Last modified on 2018/06/13

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Basic information
Official scientific title of the study Skin tension of scalp in infants
Title of the study (Brief title) Skin tension of scalp in infants
Region
Japan Europe

Condition
Condition The patients who performed via coronal incision
Classification by specialty
Neurosurgery Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate the validity of distraction osteogenesis, we investigate the difference in extension of scalp of infants between races.
Basic objectives2 Others
Basic objectives -Others In order to evaluate the validity of distraction osteogenesis, we investigate the difference in extension of scalp of infants between races.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin tension of the scalp
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
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
6 months-old <=
Age-upper limit
13 months-old >
Gender Male and Female
Key inclusion criteria Patients who is performed via coronal incision
Key exclusion criteria Patients who were previously performed via coronal incision
Target sample size 200

Research contact person
Name of lead principal investigator Kazuo Kishi
Organization Keio University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Address 35 Shinanomachi, Shinjuku-ku
TEL +81353633814
Email kkishi@a7.keio.jp

Public contact
Name of contact person Yoshiaki Sakamoto
Organization Keio University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Address 35 Shinanomachi, Shinjuku-ku
TEL +81353633814
Homepage URL
Email ysakamoto@z8.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka City General Hospital
Hopital Necker Enfants Malades
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 慶應義塾大学病院(東京都)、大阪市立総合医療センター(大阪府)、ネッカー小児病院(フランス、パリ)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 14 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 27 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Skin tension of scalp in infants are measured.

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037591

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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