? degree burns
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18, age <= 65, both sexes; 2. Patients with clinical diagnosis of third-degree burn and full-thickness skin defect; 3. The total burn area of burn patients was less than 50% total body surface area (TBSA), and degree ? was less than 20% total body surface area (TBSA); 4. Fresh scab wound was cut, and the area of the target wound was not more than 8cm x 8cm; 5. The subject will participate voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled severely infected wounds; 2. Wounds with residual foreign bodies; 3. Patients with cardiovascular, liver (ALT, AST >1.5 times the upper limit of normal value), kidney (Cr> 1.5 times the upper limit of normal value), blood system and other serious primary diseases, mental illness, poorly controlled diabetes mellitus (fasting blood glucose >= 7.8mmol/L); 4. Tumors, patients receiving radiotherapy or chemotherapy; 5. Patients with asthma, urticaria and other allergic constitutions 6. Patients with known history of allergy to silk or porcine materials; 7. Those who cannot accept pig-derived materials due to religious beliefs, ethnic groups, etc.; 8. Patients who require medical treatment that may affect trial evaluation or require concomitant medical treatment that may affect efficacy evaluation; 9. Patients who have participated in drug clinical trials within 3 months, other medical device clinical trials within 1 month, and/or are currently participating in other interventional clinical trials and have not reached the end of the trial; 10. Pregnant or lactating women; 11. Patients deemed by the investigator to be ineligible for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viability of the skin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin scarring in the skin graft area.; | — |
Countries
China