Comparative study for effectiveness of MegaDerm Plus and Split-thickness skin graft on full thickness skin defect treatment : Multicenter, subject/independent-assessor blinded, randomized, superiority, investigator-initiated study.
- Conditions
- Injury, poisoning and certain other consequences of external causes
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 84
All subjects can participate in the clinical trial only when all of the following criteria are met.
1) Those aged 19 or over and under 70 years of age
2) After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate in the clinical trial and gives written consent
3) Patients in need of reconstruction due to a loss of the entire skin layer due to an accident or disease
If any of the following items apply, the subject is excluded from the clinical trial.
1) Pregnant, lactating women
2) Those who do not have diseases that generally affect wound healing or taking medications (immunosuppressive diseases, collagen metabolic diseases, systemic vasculitis, etc.)
3) A person with a history of surgery in the same area
4) drug and alcohol addicts
5) Those with infectious skin disease
6) Those with psychiatric problems
7) Other clinical trial investigators judged to be inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional evaluation of the skin (elasticity)
- Secondary Outcome Measures
Name Time Method Functional evaluation of skin (moisture, transdermal moisture loss, melanin index, erythema index);Functional evaluation of skin (elasticity, moisture, transdermal moisture loss, melanin index, erythema index);Satisfaction Rating;Assessment of engraftment area ratio