Burn
Conditions
Interventions
experimental group:After wound debridement, use 5x5 cm genetically modified miniature pig skin to temporarily cover, and routinely bandage the wound and change dressings
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Written consent from the patient or a legally authorized agent; 2. Aged over 18 years; 3. Men or women with no reproductive potential; Women must be: Natural menopause: defined as >=55 years old, menopause for >=1 year or less than 55 years old, follicle stimulating hormone (FSH) >=40.0 IU/L; or surgical sterilization including hysterectomy, bilateral oophorectomy and/or tubal ligation; 4. The total burn area is less than 30% of deep II or III degree burns; 5. Burn wounds require surgical resection; 6. Allogeneic skin graft bridge coverage is required in clinical burn wounds; 7. Have not previously received an allogeneic skin graft; 8. The burn wound is not located on the face.
Exclusion criteria
Exclusion criteria: 1. Lactating patients; 2. HIV-infected persons or other situations that the researchers believe endanger the patient's safety; 3. Immunosuppressants are being used: (1) Antitumor drugs; (2) High-dose hormones > 10 mg prednisolone; (3) Tumor necrosis factor inhibitors; (4) Calcin inhibitors (cyclosporine, tacrolimus, etc.); (5) Other anti-cell proliferation or immunosuppressive agents; 4. History of allergy to penicillin, aminoglycoside or amphotericin; 5. Active tumors within 5 years including the need for surgery, chemotherapy, and/or radiation. Non-metastatic basal or squamous skin cancer or cervical cancer in situ can be included; 6. Patients with clinical trial drugs tested 3 days ago; 7. Previously received porcine-derived or other xenogeneic tissue products, including but not limited to: glutaraldehyde-fixed porcine or bovine-derived heart biological valves; glutaraldehyde-fixed porcine skin products; 8. BMI > 40 kg/m^2; 9. HbA1c >= 7.0%; 10. Glucocorticoid use within 30 days including inhalation; 11. Electrical injury or chemical burn; 12. End-stage renal disease, defined as MDRD CrCl 2 during skin graft treatment; 20. Wound infection before treatment; 21. Sepsis and or combined with impaired organ function; 22. Acute lung injury; 23. Life expectancy is less than 180 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events such as wound infection;Analyze the quality and duration of product bridge biological barriers; | — |
Countries
China
Contacts
Public ContactZou Lijin
The First Affiliated Hospital of Nanchang University
Outcome results
None listed