CTRI/2012/04/002592已完成3 期
A phase III randomized, double blind, multi-center study of Xylentraâ?¢ versus Silver Sulfadiazine forefficacy and safety in patients with partial thickness burns in India
Issar Pharmaceuticals Private Limited0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult male or female patients aged 18- 60 years of age.
- •Patients with diagnosed (clinically) partial thickness thermal burn
- •Total surface area of the burn 10-20% by Wallace rule of Nine
- •(Appendix 8)
- •Willing to give written informed consent.
- •Females of child-bearing potential with a negative urine or serum
- •pregnancy test on admission and agrees to take suitable method of
- •contraception for the duration of the study
- •Weight range within 20% of the ideal body weight as per standard
- •tables and Indian criteria
排除标准
- •Patients with pulmonary burns
- •Patients with full thickness burns or deep partial thickness burn.
- •Patients who need skin grafting.
- •Patients with chemical or electrical burns.
- •Immune compromised patients. (patients taking
- •immunosuppressive drugs such as glucocorticoids, alkylating agents,
- •antimetabolites, antibodies, cyclosporin, tacrolimus, sirolimus,
- •interferons, opioids, TNF binding proteins, Mycophenolate or any
- •other biological agents)
- •Patients with history of chronic GI, renal, hepatic, respiratory,
- •infectious, or History of allergy or hypersensitivity to investigational
- •drugs or autoimmune disorders.
- •Any chronic condition requiring the use of systemic corticosteroids
- •30 days prior to study entry and anytime during the course of the
- •Known or newly diagnosed diabetics requiring insulin or oral anti
- •Pregnant or breast-feeding female.
- •Known or suspected allergies to Xylentra• or silver sulfadiazine.
- •Participation in another investigational drug study within 30 days
- •prior to treatment start
- •Patients with history of any topical or systemic antimicrobial drug
- •for the current wound or taking antibiotics for co morbid condition
- •Patients suffering from any medical illnesses after burn which
- •investigator thinks will endanger patientâ??s condition.
研究者
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