UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005075 |
|---|---|
| Receipt number | 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 16:45:58 |
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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
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
ozawa@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Osaka City University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006039
