UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017614
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email morimotn@hirakata.kmu.ac.jp

Sponsor
Institute Department of Plastic and Reconstructive Surgery, Kansai Medical University,
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 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
URL(English) 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


Contact us.