UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of additional use of dermal micrograft for skin grafting
Acronym	Dermal micrograft study
Scientific Title	A comparative study between combined use of dermal micrograft and meshed skin graft versus sole meshed skin graft: A randomized controlled trial
Scientific Title:Acronym	Dermal micrograft and meshed skin graft vs. meshed skin graft: RCT
Region	Japan

Condition
Condition	Skin ulcer/Skin defect
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of epithelization promoting effect of dermal micrograft by comparing the dermal micrograft and meshed skin graft group and the sole meshed skin graft group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to complete epithelization
Key secondary outcomes	Texture of the grafted area after long term follow-up (smoothness, pigmentation, contracture, et al.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A group of combined use of dermal micrograft and meshed skin graft
Interventions/Control_2	A group of sole meshed skin graft
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	Patients who are supposed to have a operation of mesh skin grafting in the Kyorin University Hospital, and who consented to take part in the trial in advance.
Key exclusion criteria	Patients who did not agree on participation in the trial.
Target sample size	46

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Kagaya
Organization	Kyorin University Hospital
Division name	Department of plastic and reconstructive surgery
Zip code	181-8611
Address	6-20-2, Shinkawa, Mitaka, Tokyo
TEL	0422-46-6138
Email	mkagayakson@yahoo.co.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Kagaya
Organization	Kyorin University Hospital
Division name	Department of plastic and reconstructive surgery
Zip code	181-8611
Address	6-20-2, Shinkawa, Mitaka, Tokyo
TEL	0422-46-6138
Homepage URL
Email	mkagayakson@yahoo.co.jp

Sponsor
Institute	Kyorin University Hospital
Institute
Department

Funding Source
Organization	Kyorin University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyorin University Hospital
Address	6-20-2, Shinkawa, Mitaka, Tokyo
Tel	0422-47-5511 ext. 3212/3224
Email	rec@ks.kyorin-u.ac.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	2021 Year 05 Month 25 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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 25 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050617