UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017614 |
|---|---|
| Receipt number | R000020402 |
| Scientific Title | Comparative study of the efficacy of ointment treatment and wound dressing in outpatient surgery |
| Date of disclosure of the study information | 2015/05/20 |
| Last modified on | 2016/11/17 18:48:07 |
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Basic information
Public title
Comparative study of the efficacy of ointment treatment and wound dressing in outpatient surgery
Acronym
Comparative study of the efficacy of ointment treatment and wound dressing
Scientific Title
Comparative study of the efficacy of ointment treatment and wound dressing in outpatient surgery
Scientific Title:Acronym
Comparative study of the efficacy of ointment treatment and wound dressing
Region
| Japan |
Condition
Condition
Cutaneous and subcutaneous tumor, skin ulcer, scar, et al
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of wound dressing in outpatient surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Incidence of Wound complication
Key secondary outcomes
Patient comfort
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
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Apply wound dressing on the wound after outpatient surgery
Interventions/Control_2
Apply ointment on the wound after outpatient surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outsurgery surgery patiens in Department of Plastic and Reconstructive Surgery,
Kansai Medical University,
Key exclusion criteria
1.Operation site is located in face or head
2.Patients without written informed consent
3.Patients judged to be inappropliate for this trial by investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki MORIMOTO |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka,
TEL
072-804-0101
morimotn@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki MORIMOTO |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka,
TEL
072-804-0101
Homepage URL
http://www5.kmu.ac.jp/prs/index.html
morimotn@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Kansai Medical University,
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
関西医科大学附属枚方病院(Kansai Medical University Hirakata Hospital)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020402
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
