CTRI/2014/01/004350
已完成
4 期
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
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Bharat Biotech International Limited
- 入组人数
- 500
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
未指定
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