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 | 2025/10/02 10:13:43 |
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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
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
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
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
no URL
Publication of results
Unpublished
Result
URL related to results and publications
no URL
Number of participants that the trial has enrolled
40
Results
The median number of days to epithelialization was 9.5 days in the back graft group and 20.0 days in the control group.
The median VSS score was 2.5 in the back graft group and 4.5 in the control group.
Machine-based color measurements of a*b* and L* showed that the back graft group had scars closer to the healthy area.
Skin grafting resulted in a favorable course of scarring at the donor site.
Results date posted
| 2025 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients ranged in age from 20 to 94 (mean age 61), with 30 men and 10 women. The primary diseases for which skin grafting was indicated were burns in 19 patients, intractable ulcers in 12, skin defects after tumor resection in 4, skin flap donor sites in 2, degloving in 2, subcutaneous hematoma in 2, scar contracture in 2, foot gangrene in 1, and Fournier's gangrene in 2.
Underlying diseases included diabetes in 13 patients and hypertension in 12.
Participant flow
The study included patients aged 20 years or older who underwent split-thickness skin grafting at the Department of Plastic Surgery, Kawasaki Medical School Hospital, between April 2020 and September 2023.
Only cases in which skin was harvested from the thigh were extracted, and 18 cases who were transferred to other hospitals during the follow-up period or who were unable to be seen 6 months after surgery due to self-interruption were excluded, resulting in a follow-up observation of 21 cases.
Adverse events
Hypertrophic scarring and wound infection were observed.
Outcome measures
The number of days to epithelialization, VSS, and color evaluation using a spectrophotometer were performed.
The median time was 9.5 days (minimum 7, maximum 12) in the back graft group and 20.0 days (minimum 8, maximum 32) in the control group, with a significant difference of p<0.05.
One case in the control group involved erosion and delayed epithelialization due to infection, but no other cases showed any obvious complications such as infection.
The median VSS was 2.5 (minimum 0, maximum 5) in the back graft group and 4.5 (minimum 1, maximum 8) in the control group, with a significant difference of p<0.05.
Machine-based color measurements of a* and b*, which indicate hue and saturation, showed a median of 4.45 (minimum 2.90, maximum 7.05) in the back graft group and a median of 8.57 (minimum 3.12, maximum 113.38) in the control group, p<0.05, showing a significant difference, indicating that the back graft group had scars significantly closer to the color of the healthy area. For L*, which indicates brightness, we simply examined the distance along the L* axis. The distance between two points on the donor site and the healthy area was a median of 6.70 (minimum 0.86, maximum 7.05) in the back graft group and a median of 15.56 (minimum 3.70, maximum 22.12) in the control group, p<0.05, showing a significant difference, indicating that the back graft group also had scars closer to the healthy area in brightness.
Minced skin grafting demonstrated favorable progress in the donor site scar.
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
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044394
