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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008175

Enrollment

Registered

2023-02-10

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : It is a clinical trial to confirm the effectiveness and safety of using CGDerm Matrix as a dermal replacement when performing Split Thickness Skingraft in patients with skin defect

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Success rate of skin transplantation at 4 weeks postoperative (%)	—

Secondary

Measure	Time frame
Production rate of skin grafts at 2 to 4 weeks after surgery (%)	—

Countries

Korea, Republic of

Contacts

Public ContactEunju Lee

Asan Medical Center

eun2127@nate.com+82-2-2045-4291

Outcome results