UMIN-CTR Clinical Trial

Basic information
Public title	comparison of negative pressure wound therapy between V.A.C and Renasys
Acronym	comparison of negative pressure wound therapy
Scientific Title	comparison of negative pressure wound therapy between V.A.C and Renasys
Scientific Title:Acronym	comparison of negative pressure wound therapy
Region	Japan

Condition
Condition	burn and skin defect
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is intended that a half side tests using the form of two companies reveal the difference of the wound heeling and granulation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	size, the condition of granulation, histology
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Each form of VAC and RENASYS is used to a half of wound region.
Interventions/Control_2
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	The patient who obtained its consent for the competitive examination of the negative pressure wound therapy with a skin defect or a burn
Key exclusion criteria	1. The patient with infection 2. The patient with necrosis tissue 3. The patient who has poor control of the bleeding 4. The patient having the allergic symptoms such as bronchial asthma, hives 5. In addition, the patient, judged the participation in this study to be inappropriate by the attending doctor
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Takaharu Middle name Last name Hatano
Organization	Osaka City University
Division name	Plastic and reconstructive surgery
Zip code	5458585
Address	1-4-3, Asahi-cho, Abeno-ku, Osaka-city
TEL	06-6645-3892
Email	hatano0321@yahoo.co.jp

Public contact
Name of contact person	1st name Takaharu Middle name Last name Hatano
Organization	Osaka City University
Division name	Plastic and reconstructive surgery
Zip code	5458585
Address	1-4-3, Asahi-cho, Abeno-ku, Osaka-city, Osaka-fu
TEL	06-6645-3892
Homepage URL
Email	hatano0321@yahoo.co.jp

Sponsor
Institute	Plastic and reconstructive surgery, Osaka City University
Institute
Department

Funding Source
Organization	Plastic and reconstructive surgery, Osaka City University
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	Osaka City University, Plastic and reconstructive surgery
Address	1-4-3, Asahi-cho, Abeno-ku, Osaka-city, Osaka-fu
Tel	06-6645-2121
Email	hatano0321@yahoo.co.jp

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	2012 Year 11 Month 12 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	1
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	2012 Year 11 Month 12 Day
Date of IRB	2014 Year 04 Month 02 Day
Anticipated trial start date	2012 Year 11 Month 12 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 11 Month 07 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010893