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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039927
Receipt No. R000044394
Scientific Title Study of promoting wound healing of the donor-site after split-thickness skin grafting.
Date of disclosure of the study information 2020/03/31
Last modified on 2020/03/24

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Basic information
Public title Study of promoting wound healing of the donor-site after split-thickness skin grafting.
Acronym Study of promoting wound healing of the donor-site after split-thickness skin grafting.
Scientific Title Study of promoting wound healing of the donor-site after split-thickness skin grafting.
Scientific Title:Acronym Study of promoting wound healing of the donor-site after split-thickness skin grafting.
Region
Japan

Condition
Condition Burn, ulcer, skin tumor, and tumor which needs reconstructive surgery.
Classification by specialty
Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluating whether minced skin grafting promotes wound healing and improving donor-site appearance after split-thickness skin grafting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluating the postoperative appearance with Vancouver Scar Scale and photographs at 1, 2, 4 weeks and 6 months after surgery.
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
Maneuver
Interventions/Control_1 The skin graft is minced using scissors and apply to donor site.
evaluating the postoperative appearance with Vancouver Scar Scale and photographs at 1, 2, 4 weeks and 6 months after surgery.
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 seeing the plastic surgery doctor and planned split-thickness skin grafting.
Key exclusion criteria There are not particularly notes.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shogo
Middle name
Last name Ebisudani
Organization kawasaki medical school
Division name plastic surgery
Zip code 701-0192
Address 577 Matsushima , Kurasiki City , Okayama prefecture
TEL 086(462)1111
Email prs@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Miori
Middle name
Last name Takasu
Organization kawasaki medical school
Division name plastic surgery
Zip code 701-0192
Address 577 Matsushima , Kurasiki City , Okayama prefecture
TEL 086(462)1111
Homepage URL
Email prs@med.kawasaki-m.ac.jp

Sponsor
Institute kawasaki medical school
plastic surgery
Institute
Department

Funding Source
Organization kawasaki medical school
plastic surgery
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 kawasaki medical school
Address 577 Matsushima , Kurasiki City , Okayama prefecture
Tel 086(462)1111
Email kmsrec@med.kawasaki-m.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
2020 Year 03 Month 31 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
2019 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 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
2020 Year 03 Month 25 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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