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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005075
Receipt No. R000006039
Scientific Title Comparative study of surgical scar and complications with different suture strings
Date of disclosure of the study information 2011/02/14
Last modified on 2011/08/17

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Basic information
Public title Comparative study of surgical scar and complications with different suture strings
Acronym Comparative study of surgical scar and complications with different suture strings
Scientific Title Comparative study of surgical scar and complications with different suture strings
Scientific Title:Acronym Comparative study of surgical scar and complications with different suture strings
Region
Japan

Condition
Condition examination of surgical scar and complications with different suture strings
Classification by specialty
Surgery in general Urology Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 examination of surgical scar and complications with different suture strings
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The comparison between postoperative scar and complications.
Based on a clinical photograph ( post 1 month, post 3 months, post 6 months, post 1 year), we evaluate the difference with the surgical scar, the difference with suture strings.
Key secondary outcomes wound complications
hypertrophic scar
Aesthetics
wound closure time
cost

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 A group: Surgical wound is divided in half.The upper part is sutured with PDS and the lower part is sutured with V-Loc 180.
Interventions/Control_2 B group: Surgical wound is divided in half.The upper part is sutured with V-Loc180 and the lower part is sutured with PDS.
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1,Written informed consent.
2,Surgical wound was 10cm or more.
Key exclusion criteria 1,Clinically significant infectious disease.
2,Emergency surgery
3,Patients who are considered unsuitable for this study by the investigator.
4,Surgical wound was less than 10cm.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka City University
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Asahi 1-4-3, Abeno, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka City University
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Asahi 1-4-3, Abeno, Osaka
TEL 06-6645-3892
Homepage URL
Email ozawa@med.osaka-cu.ac.jp

Sponsor
Institute Department of Plastic and Reconstructive Surgery, Osaka City University, Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 02 Month 14 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 Enrolling by invitation
Date of protocol fixation
2011 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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

Management information
Registered date
2011 Year 02 Month 14 Day
Last modified on
2011 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006039

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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