Burn
Conditions
Interventions
Shallow ? degree low dose group:Recombinant human platelet-derived growth factor gel low dose group
Shallow ? degree medium dose group:Recombinant human platelet-derived growth factor gel medium dose group
Shallow grade II placebo dose group:Recombinant human platelet-derived growth factor gel placebo dose group
Deep ? degree medium dose group:Recombinant human platelet-derived growth factor gel medium dose group
Deep ? degree high dose group:Recombinant human platelet-derived growth factor gel high-dose group
Deep ? degree placebo dose group:Recombinant human platelet-derived growth factor gel placebo dose group
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant and non-lactating female subjects between the ages of 18 and 75 (including the boundary value) (the blood pregnancy test of fertile women during the screening period was negative); 2. Be hospitalized within 48 hours after burn; 3. The total burned area is less than 30%, and the burn depth of the target wound is in line with shallow ? degree or deep ? degree; 4. The target wound is isolated or delimitable and the area is between 20 and 400cm2 (including the boundary value) [the target wound does not include the face, eye area, ear, perineum and genital area]; 5. Male and female subjects with reproductive capacity shall ensure that effective contraceptive measures are taken during the treatment period to 1 month after the treatment; 6. Voluntarily participate in clinical trials and sign informed consent; 7. Able and willing to participate in program visits and follow research procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with chemical burns, electrical contact burns or with obvious symptoms of infection upon admission; When the burn depth was ? degree, the wound area was more than 3% of the body surface area. When there were multiple wounds, the burn depth of the wounds adjacent to the shallow ? degree or deep ? degree target wound was ? degree and it was not easy to be treated or bandaged separately. 2. Burn combined with combined injury or shock, combined with serious inhalation injury; 3. Allergic constitution, have a clear history of drug or food allergy, especially allergic to any ingredients in this product and auxiliary materials; 4. Combined with any serious or uncontrolled systemic disease, as determined by the investigator: serious heart disease with a definite diagnosis prior to screening, such as unstable angina attacks, cardiac insufficiency, myocardial infarction, or NYHA rating = 3; Have chronic kidney disease, renal insufficiency, creatinine (Cr) >1.5×ULN, or creatinine clearance (Ccr) =50 mL/min (according to Cockcroft and Gault formula *); There were definite liver diseases, liver function ALT>2.5 ULN, AST>2.5 ULN; Diabetic patients with poor blood glucose control: fasting blood glucose > 7mmol/L, or random blood glucose = 11.1mmol/L, HbA1c = 8.0%; Patients with immune dysfunction, such as HIV-infected patients; 5. Related skin diseases that may cause the wound to not heal properly; 6. People with mental disorders and those who have no self-knowledge and cannot accurately express themselves; 7. Patients who used growth factor dressings on target wounds during screening; 8. Did not participate in clinical trials of interventional drugs/medical devices within the last three months; 9. Patients who have been diagnosed with tumors based on previous or current histological or cytological diagnoses; 10. Other patients deemed unsuitable for inclusion by the physician based on clinical experience. * Cockcroft and Gault formula [Ccr (endogenous creatinine clearance), Scr (blood creatinine)] : Ccr=[(140- age)× body weight (kg)]/[72×Scr(mg/dl)] Or Ccr=[(140- age)× body weight (kg)]/[0.818×Scr(umol/L)] For females, the calculated result was x 0.85
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for complete healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with complete healing;The wound healing condition;Safety end points; | — |
Countries
China
Contacts
Public ContactWu Jun
Shenzhen Second People's Hospital
Outcome results
None listed