UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033890 |
|---|---|
| Receipt number | 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 17:26:08 |
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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
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
miyanaga@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038651
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
