Burn
Conditions
Interventions
Deep II degree high dose group:High-dose recombinant human platelet-derived growth factor gel
Deep II degree placebo group:Placebo
Deep II degree low dose group:Low-dose recombinant human platelet-derived growth factor gel
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, non-lactating female participants aged 18 to 75 years (inclusive). (Female participants of childbearing potential must have a negative serum pregnancy test at screening). 2. Admitted to the hospital within 48 hours of sustaining the burn injury. 3. Total Burn Surface Area (TBSA) <= 30%, with the target wound depth consistent with deep second-degree burns. 4. The target wound is an isolated wound or a wound with distinguishable boundaries, and has an area between 30 and 300 cm^2 (inclusive). [Target wounds exclude the head and face, periorbital region, ears, perineum, and genitalia]. 5. Male and female participants of childbearing potential must agree to use effective contraceptive measures during the treatment period and for 3 months after the end of treatment. 6. Voluntarily participates in the clinical trial and signs the Informed Consent Form (ICF). 7. Able and willing to attend scheduled visits and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with chemical burns, electrical contact burns, or obvious signs of infection upon hospital admission. In cases with multiple wounds, patients are excluded if a wound adjacent to the target deep second-degree wound is a third-degree burn and it is not feasible to treat or dress them separately. 2. Patients with combined injuries involving the target wound, or burns complicated by shock or severe inhalation injury. 3. Patients with a history of allergic diathesis (allergic constitution), a known history of drug or food allergies, or hypersensitivity to any component of the study drug or its excipients. 4. Patients with any severe or uncontrolled systemic disease, as judged by the Investigator: (1) Severe heart disease with a confirmed diagnosis, such as unstable angina pectoris, cardiac insufficiency, myocardial infarction, or NYHA (New York Heart Association) Functional Classification >= Class III (see Appendix 10 for specific classification). (2) Chronic kidney disease with renal insufficiency: Creatinine (Cr) > 1.5 × ULN and Creatinine Clearance Rate (Ccr) 2.5 × ULN or AST > 2.5 × ULN. (4) Poorly controlled blood glucose: Fasting Blood Glucose > 7 mmol/L or Random Blood Glucose >= 12 mmol/L, or Glycated Hemoglobin (HbA1c) >= 8.0%. (5) Patients with immunodeficiency disorders, such as HIV infection. 5. Patients with relevant skin diseases that may prevent normal wound healing or interfere with the assessment of efficacy. 6. Patients with psychiatric disorders, or those lacking insight and unable to express themselves clearly. 7. Use of prohibited medications or treatments (such as growth factors, functional dressings, etc.) on the target wound within 24 hours prior to enrollment, which, in the Investigator's assessment, may interfere with the evaluation of the study drug. 8. Participation in an interventional drug or medical device clinical trial within the past three months. 9. Patients with a confirmed diagnosis of malignancy based on previous or current histology, cytology, or imaging. 10. Other patients deemed unsuitable for inclusion based on the Investigator's clinical experience.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for complete healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| The wound healing condition;Safety end points; | — |
Countries
China
Contacts
Public ContactWu Jun
Shenzhen Second People's Hospital
Outcome results
None listed