Burn
Conditions
Interventions
Multiple genetically modified pig skin group (Experimental group):The burn wound after debridement was selected as the experimental site and randomly assigned to two skin grafting areas (similar wound
Sponsors
Department of Burns and Cutaneous Surgery, the First Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 70, regardless of gender; 2. Patients with deep burns (deep II-III degrees) area >= 5% of total body surface area (TBSA) requiring skin grafting. Diagnosis and judgment are made by two attending or more senior physicians; 3. Patients without serious infection on the burn wound; 4. Subjects or immediate family members are fully informed and voluntarily sign informed consent, and can complete the study and follow-up in accordance with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with sevely infection on the burn wound; 2. Patients with immune dysfunction, such as infected with HIV, or diagnosed with systemic immune diseases, or orther conditions affetcing immune function, such as suffering with tumor, reciveing radiotherapy or chemotherapy, systemic administration of steroid or the application of immunosuppressants; 3. Patients with severe primary diseases of cardiovascular, liver, kidney and blood system, mental illness and poorly controlled diabetes; 4. Patients who reciving xenogeneic/allogeneic tissue or organ transplantation previously; 5. Those who cannot accept pig-derived materials due to religious belief, ethnicity, etc.; 6. Patients who were enrolled in orther clinical studies within 3 months; 7. Pregnancy, lactation, or other patients who are not eligible to participate in the study according to the researchers' assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time of skin graft (Multiple genetically modified pig skin / Allogenic skin); | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin graft barrier function;Survival rate of second stage autologous skin graft;Scar score after wound healing;Laboratory tests (blood routine, biochemistry, coagulation function);Detection of porcine endogenous retroviruses;Adverse events;Pathological examination of skin graft; | — |
Countries
China
Contacts
Public ContactHan Juntao
Department of Burns and Cutaneous Surgery, the First Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed