UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044314 |
|---|---|
| Receipt number | R000050617 |
| Scientific Title | A comparative study between combined use of dermal micrograft and meshed skin graft versus sole meshed skin graft: A randomized controlled trial |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2021/05/25 12:52:37 |
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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
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
mkagayakson@yahoo.co.jp
Sponsor or person
Institute
Kyorin University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050617
