Bind
Conditions
Interventions
test groupA:test product
test groupB:test product
control group:Placebo Product
Sponsors
Affiliated Hospital of Jiangnan University
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 years (including boundary values) (fertile female screening blood pregnancy test negative); 2. Hospitalized within 48 hours after burn; 3. (shallow/deep) ? degree burn, total burn area <= 15%, target wounds are isolated wounds with an area between 20~200cm^2 (including boundary values) [target wounds do not include face, eye area, trans-joint (such as fingers), ears, perineum and genitalia]; 4. Fertile male and female subjects are guaranteed to use effective contraceptive measures within 3 months of the end of treatment; 5. Voluntarily participate in clinical trials and sign informed consent; 6. Be able and willing to participate in planning visits and follow research procedures.
Exclusion criteria
Exclusion criteria: 1. Chemical burns, electrical contact burns, burns over 15% of a total body area (TSBA), or patients with obvious symptoms of infection upon admission; When there were multiple wounds, the burn depth of the most severe wound was ? degree; 2. Burn with combined injury or shock, combined with severe inhalation injury; 3. Allergic constitution, with a history of drug or food allergy, especially allergic to any ingredients in this product and auxiliary materials; 4. In the judgment of the investigator, with any serious or uncontrollable systemic disease: Prior to the screening, there was a definite diagnosis of severe heart diseases, such as unstable angina attack, cardiac insufficiency, myocardial infarction, or NYHA cardiac function grade >= 3; Chronic kidney disease, renal insufficiency, creatinine (Cr) & GT; 1.5 x ULN, or Ccr 2.5 x ULN. Diabetic patients with poor blood glucose control: fasting blood glucose > 7mmol/L, or 2 hours postprandial blood glucose > 10mmol/L, or hBA1c > 7% (for diabetic patients, the researchers selected one of the three patients for detection and judgment according to the patient's medical conditions); Patients with immune disorders, such as HIV infection; Hepatitis B surface antigen (HBsAg), Hepatitis B E antigen (HBeAg), and hepatitis B core antibody (HBcAb) were positive. Hepatitis C virus (HCV) antibody positive; 5. Related skin diseases that may cause wound healing failure; 6. Patients who have taken immunosuppressive drugs within 1 month; 7. Screening patients who received growth factor drug treatment within the previous 1 week; 8. Patients who used growth-causing dressings during the screening period; 9. Those with mental disorders and those without self-awareness and unable to express themselves accurately; 10. Participants in clinical trials of other new drugs within the last 3 months; 11. Patients diagnosed with tumors based on previous or current histological or cytological diagnosis; 12. Other patients deemed unsuitable for inclusion by the doctor based on clinical experience. * Cockcroft and Gault formula [Ccr (endogenous creatinine clearance), Scr (serum creatinine)]: Ccr=[(140- age)x body weight (kg)]/[72 x Scr(mg/dl)] Or Ccr=[(140- age)x body weight (kg)]/[0.818 x Scr(umol/L)] Females were calculated x 0.85.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observe the safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy, pharmacokinetics and immunogenicity were evaluated; | — |
Countries
China
Contacts
Public ContactLyu Guozhong
Outcome results
None listed