UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of the efficacy of ointment treatment and wound dressing in outpatient surgery
Title of the study (Brief title)	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	Naoki MORIMOTO
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
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	Naoki MORIMOTO
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020402