Health Condition 1: null- Burns. Health Condition 2: X088- Exposure to other specified smoke,fire and flames
Conditions
Interventions
Intervention1: SLVRGEN: apply twice a day on burns till it heals
Control Intervention1: None: None
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient is able to understand and has signed the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required. Patient with Superficial Partial Thickness Burns. Patients are expected to be available for the 2-3 week study period and are able to adhere to the treatment regimen. Patients (male or female) aged between 10 to 60 years
Exclusion criteria
Exclusion criteria: Presence of a systemic or deep local infection such as: purulent drainage, osteomyelites or as non-viable tissue that cannot be removed by debridement. Life threatening or serious cardiac disease (NYHA grades III-IV), gastro-intestinal, hepatic, renal, endocrine, hematological or immunologic disorder. Known case of hypersensitivity to the incipient(s). Uncontrolled diabetes mellitus (type I or II), diabetic ketoacidosis or coma. Pregnant woman and nursing mothers. Past history of current acute or chronic auto-immune disease. Chronic alcohol abuse (40ml/day) for at least 6 month Patient receiving or has received within one month prior to visit.1 any treatment known to impair wound healing including but not limited to: corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy & chemotherapy. Use of any marketed or investigational or herbal medicine or non-registered drug for wounds 30 days prior to the screening. Any criteria which in the opinion of the investigator, suggests that the patient would not be comply with the study. Treatment with a dressing containing any other growth factors or other biological dressings within 30 days, prior to the screening visit. Participation in another clinical study within 30 days prior to the screening visit or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint criterion is assessing AEs throughout the course of the study over all. Timepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of healing Quality of skin adnexa i.e. appearance of hair, any scar or contracture formation, and pigmentation Timepoint: Baseline to Heal | — |
Countries
India
Contacts
Public ContactDrAnit Singh
Bharat Biotech International Ltd
Outcome results
None listed