UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041418 |
|---|---|
| Receipt number | R000047288 |
| Scientific Title | Evaluation of the Split-thickness skin graft donor-site of the elderly patients |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2023/08/25 23:01:51 |
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Basic information
Public title
Evaluation of the Split-thickness skin graft donor-site of the elderly patients
Acronym
Evaluation of the Split-thickness skin graft donor-site of the elderly patients
Scientific Title
Evaluation of the Split-thickness skin graft donor-site of the elderly patients
Scientific Title:Acronym
Evaluation of the Split-thickness skin graft donor-site of the elderly patients
Region
| Japan |
Condition
Condition
skin defect
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the better place(either thigh or leg) for the split-thickness skin grafts donor-site for the elderly patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the days the wound needed for epithelization
Key secondary outcomes
Visual Analogue Scale
Vancouver scar scale
EQ5D5L
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
At the operation, split-thickness skin grafts were obtained from the thigh.
Interventions/Control_2
At the operation, split-thickness skin grafts were obtained from the leg.
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who need skin graft.
60 years or older.
Patients without wound at the donor site.
Key exclusion criteria
Patients with steroid drug, immunosuppressive drug or anticancer drug.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nishioka |
Organization
Shinshu University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
011-81-263-35-4600
hiroshi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nishioka |
Organization
Shinshu University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
011-81-263-35-4600
Homepage URL
hiroshi@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Plastic and Reconstructive Surgery, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
3-1-1 Asahi Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2020 | Year | 08 | Month | 14 | 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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047288
