UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048689 |
|---|---|
| Receipt number | R000055477 |
| Scientific Title | Multicenter prospective observational study to evaluate split thickness skin graft procedures. |
| Date of disclosure of the study information | 2022/08/18 |
| Last modified on | 2025/02/18 20:49:54 |
* 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
Multicenter prospective observational study to evaluate split thickness skin graft procedures.
Acronym
Multicenter prospective observational study to evaluate split thickness skin graft procedures.
Scientific Title
Multicenter prospective observational study to evaluate split thickness skin graft procedures.
Scientific Title:Acronym
Multicenter prospective observational study to evaluate split thickness skin graft procedures.
Region
| Japan |
Condition
Condition
acute wounds
Classification by specialty
| Surgery in general | Plastic surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate split-thickness skin graft procedures. Namely, (1) the split-thickness skin graft procedure with arbitrary magnification, (2) the split-thickness skin graft procedure with arbitrary magnification after artificial dermis transplantation and (3) the sandwich method with the artificial dermis would be compared. The purpose of this study is to clarify which of those proceures is better for the condition of the healed wound (scar) than other surgical methods. In terms of the nature of the research, it is a confirmatory research (research for giving conclusions to existing hypotheses).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POSAS score at 3 months after initial procedure.
Key secondary outcomes
Vancouver Scar Scale 3 months after initial procedure, the ratio of the area of the skin harvesting area to the area of the skin grafting area, days to 95% wound closure, rate of wound closure at 4 weeks after initial procedure, duration of wound closure, and rate of complications of wound infection.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Properly debridement skin defects aged 18 years and older
Key exclusion criteria
Infected wounds, diabetic ulcers with exacerbation in which skin graft engraftment cannot be expected, venous stasis ulcers, skin defect wounds due to ischemic ulcers, burn injury with burn index (BI) of 20 or higher, or prognostic burn index (PBI) of 90 or higher, wound area less than 1% body surface area
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Sato |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0332251323
yukiosato.a6@keio.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Sato |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0332251323
Homepage URL
yukiosato.a6@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
0333531211
med-rinri-jimu@adst.keio.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
東京医科大学病院形成外科（東京都）、東北大学病院形成外科（宮城県）、平鹿総合病院形成外科（秋田県）、鳥取大学医学部附属病院高度救命救急センター（鳥取県）、山形大学医学部附属病院形成外科（山形県）、産業医科大学病院形成外科（福岡県）、長崎大学病院形成外科（長崎県）、北里大学病院形成外科・美容外科（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collected items includ age, sex, medical history, living history, oral medications, injury or disease causing skin defect, surgical method, surgical site, concurrent treatment, postoperative complications, area of skin defect, and skin sample area, Vancouver Scar Scale (VSS) and The Patient and Observer Scar Assessment Scale (POSAS) scores at 3 months after initial surgery, days to 95% wound closure, rate of wound closure at 4 weeks after surgery and the period required to close the wound.
Management information
Registered date
| 2022 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055477
