UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033890
Receipt No. R000038651
Scientific Title Minced Skin Grafting for Promoting Wound Healing and Improving Donor Site Appearance after Split-thickness Skin Grafting: A Prospective Half-side Comparative Trial
Date of disclosure of the study information 2018/08/31
Last modified on 2018/08/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Minced Skin Grafting for Promoting Wound Healing and Improving Donor Site Appearance after Split-thickness Skin Grafting: A Prospective Half-side Comparative Trial
Acronym Minced skin grafting for split-thickness skin grafting
Scientific Title Minced Skin Grafting for Promoting Wound Healing and Improving Donor Site Appearance after Split-thickness Skin Grafting: A Prospective Half-side Comparative Trial
Scientific Title:Acronym Minced skin grafting for split-thickness skin grafting
Region
Japan

Condition
Condition Donor Site after Split-thickness Skin Grafting
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to investigate whether Minced grafting reduces the healing time and improves the sequential postoperative appearance of donor sites.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Comparison of healing times between the MG and control groups
・Comparison of postoperative appearance between the MG and control
Key secondary outcomes To determine the cause of the conspicuous appearance of the donor site and complications of MG.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Minced grafting
Interventions/Control_2 None Minced grafting
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria were patients treated with STSG during the study period, aged >18 years, and provision of signed written informed consent.
Key exclusion criteria ・aged < 18 years
・no provision of signed written informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Miyanaga
Organization Kanazawa Medical University
Division name Plastic surgery
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Email miyanaga@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Miyanaga
Organization Kanazawa Medical University
Division name Plastic surgery
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Homepage URL
Email miyanaga@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 金沢医科大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 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
This prospective half-side comparative trial demonstrates that MG promotes wound healing and improves early postoperative appearance of the donor site after STSG. MG may reduce hypertrophic scarring and dyspigmentation of the STSG donor site. 
Almost all conspicuous donor sites  at 1 month were caused by redness, but it gradually reduced. However, pigmentation of donor sites gradually increased until 6 months postoperatively. Dyspigmentation increased from postoperative month 6, and hypertrophic scarring increased from month 12. 
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
2014 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 25 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038651

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.