UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039927
Receipt number 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 2023/03/28 13:56:21

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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 or person

Institute

kawasaki medical school
plastic surgery

Institute

Department

Personal name



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

40

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

No longer recruiting

Date of protocol fixation

2019 Year 10 Month 16 Day

Date of IRB

2020 Year 06 Month 21 Day

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

2023 Year 03 Month 28 Day



Link to view the page

Value
https://center6.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