A study on Efficacy and Safety Evaluation as a Dermal Substitute for CGDerm Matrix for the patients with Skin Defect
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0008175
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
1. adults aged 19 to 75
2. Patients with pericardial or full-layer skin damage requiring skin transplantation
3. A person who can understand and follow the instructions and participate in the entire clinical trial period
4. Patients who have agreed to participate in clinical trials
1. Those whose depth of skin damage is less than or equal to the whole layer of dermis
2. Those with an expected remaining life span of less than 6 months
3. When a drug (FGF, EGF, PDGF, etc.) for the treatment of skin defects excluding dressing has been administered within the past two weeks. However, if a steroid-free drug is administered among general medicine ointment, it shall be administered within three days.
4. In the case of uncontrolled diabetes (HbA1c99.5%), endocrine or metabolic diseases such as thyroid disease, and severe psychiatric diseases (uncontrolled by drugs, mental retardation, dementia, schizophrenia, bipolar disorder, major depression, mood disorders, personality disorders, and other psychotic disorders).
5. Immunocompromised patients
6. A person who has participated in another clinical trial within two months before the start of the test
7. Women who are positive for HCG tests, pregnant women, lactating women, or pregnant women who do not use appropriate contraception methods when screening
8. Subjects deemed difficult to perform clinical trials when judging other responsible researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of skin transplantation at 4 weeks postoperative (%)
- Secondary Outcome Measures
Name Time Method Production rate of skin grafts at 2 to 4 weeks after surgery (%)