UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006695 |
|---|---|
| Receipt number | R000007910 |
| Scientific Title | Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery. |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2014/12/09 09:57:25 |
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Basic information
Public title
Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Acronym
Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Scientific Title
Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Scientific Title:Acronym
Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Region
| Japan |
Condition
Condition
Keloid and Hypertrophic Scar
Classification by specialty
| Surgery in general | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate preventive effect of tranilast administration from early postoperative period on keloid and hypertrophic scar after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of Keloid and Hypertrophic Scar
Key secondary outcomes
Symptom
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
tranilast
Interventions/Control_2
control : No treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who undergo Obstetrics and gynecology surgery
Key exclusion criteria
Keloid and Hypertrophic Scar
Pregnant women and women suspected of being pregnant
Patients with a history of hypersensitivity to any of the
ingredients of tranilast.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamiko Tosa |
Organization
Nippon Medical School Musashi Kosugi Hospital
Division name
Division of Plastic and Reconstructive Surgery
Zip code
Address
1-396 Kosugi-cho,nakahara-ku,kawasaki,kanagawa ,Japan
TEL
044-733-5181
tosa-m@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fusae Yoshida |
Organization
Nippon Medical School Musashi Kosugi Hospital
Division name
IRB
Zip code
Address
1-396 Kosugi-cho,nakahara-ku,kawasaki,kanagawa ,Japan
TEL
044-733-5181
Homepage URL
fl-0351@nms.ac.jp
Sponsor or person
Institute
Division of Plastic and Reconstructive Surgery, Nippon Medical School Musashi Kosugi Hospital
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
日本医科大学武蔵小杉病院
Nippon Medical School Musashi Kosugi Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 09 | Day |
Last modified on
| 2014 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007910
