A PROSPECTIVE MULTI-CENTRE, POST MARKETING SURVELLANCE (PMS) STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SLVRGEN (RHEGF+ 1% SILVER SULFADIAZINE + 0.2% W/W CHLORHEXIDINE GLUCONATE) IN PATIENTS WITH SUPERFICIAL PARTIAL-THICKNESS BURNS. - SLVRGE

Bharat Biotech International Limited0 个研究点目标入组 500 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

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