A study on Efficacy and Safety Evaluation as a Dermal Substitute for CGDerm Matrix for the patients with Skin Defect

Asan Medical Center0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年3月6日

适应症

试验速览

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•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

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