UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	OASIS extracellular matrix clinical efficacy study
Title of the study (Brief title)	OASIS study
Region	Japan

Condition
Condition	patient having donor site for split-thickness skin graft
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluation of OASIS extracellular matrix efficacy for donor site for split-thickness skin graft
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pathologic evaluation of donor site after healing
Key secondary outcomes	time to healing

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	half side test of extracellular matrix and conventional treatment for split thickness donor site. the term of intervention is until healing of donor site. biopsy of donor sites applied OASIS and conventional treatment after healing.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients having split thickness donor site
Key exclusion criteria	infectious wound
Target sample size	10

Research contact person
Name of lead principal investigator	yutaro yamashita
Organization	kyorin university hospital
Division name	plastic surgery
Address	2-2, sinkawa 6-chome, mitaka, tokyo, japan
TEL	0422-47-5511
Email	thestarstripjp@yahoo.co.jp

Public contact
Name of contact person	yutaro yamashita
Organization	kyorin university hospital
Division name	plastic surgery
Address	2-2, sinkawa 6-chome, mitaka, tokyo, japan
TEL	0422-47-5511
Homepage URL
Email	thestarstripjp@yahoo.co.jp

Sponsor
Institute	kyorin university hospital
Institute
Department

Funding Source
Organization	kyorin university hospital department of plastic surgery
Organization
Division
Category of Funding Organization	Other
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	杏林大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 07 Day
Last modified on	2018 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029863