CTRI/2014/11/005188已完成3 期
Comparative Efficacy, Safety and Tolerability of Silver Sulfadiazine Cream (Nanonized) 0.5% w/w and Silverex Cream 1% w/w in the Prophylaxis of Infection in Burn Wounds – A Double-Blind, Randomized, Pivotal Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 29
- 主要终点
- To compare the efficacy of Silver Sulfadiazine cream (Nanonized) 0.5% w/w with Silverex cream 1% w/w in the prophylaxis of infection in burn wounds
研究概览
简要总结
This study is a randomized, double-blind, comparative, parallel-group, multicentric Study, where treatment with the study medication will be continued until the wound heals or up to a period of 21 days, whichever is earlier. Subjects who achieve complete wound closure of all wounds before Day 21 will be considered to have completed the study as per protocol. In these subjects, further treatment with the study medication will be stopped. At the end of 21 days of treatment period, the study treatment will be discontinued. However, all subjects requiring further treatment of their burn wound will be treated as per the discretion of the investigator.
Study will be initiated only after obtaining regulatory approval & EC approval from respective sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex aged between 12 and 65 years (both inclusive) and who have given written informed consent or assent to participate in the study.
- •Additional written informed consent will be taken from parents or legally acceptable representative (LAR) [as applicable] in case assent is taken from subjects aged less than 18 yrs
- •Subjects with partial thickness burns of thermal origin covering 5-10% (both inclusive) of the total body surface area (TBSA) and suitable for outpatient management.
- •Subjects in whom burn injury is less than 24 hours old at the time of screening.
- •Subjects with clean, non-infected wound as judged by the investigator.
排除标准
- •Subjects with history of hypersensitivity to silver sulfadiazine, other sulfonamides, chlorhexidine or any of the excipients of study formulations.
- •Subjects with burn wounds associated with chemical, electrical or inhalational injury.
- •Subjects with full thickness burns (a burn involving destruction of the entire epidermis and dermis, leaving no residual epidermal cells to repopulate) or circumferential burns (a burn which encircles an entire body part) or superficial burn (a burn which remains confined to the epidermis).
- •Subjects with burns involving genitalia, head (including face) or perineum
- •Subjects with burns of hands or feet or major joints likely to cause functional impairment.
- •Subjects with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity and mortality.
- •Burn injury in subjects with preexisting medical disorders (e.g., diabetes mellitus, cancer or other immunocompromising conditions) that could complicate management, prolong recovery, or affect mortality.
- •Subjects who are under treatment with topical or systemic steroid medications or immunosuppressive agents.
- •Subjects with significant disease(s) or disorder(s) other than burn injury that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
- •Subjects with history of glucose-6-phosphate dehydrogenase deficiency.
- •Subjects with history of substance abuse as per DSM IV criteria.
- •Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test at screening.
- •Subjects who are unable or unwilling to comply with the study procedures.
- •Subjects who have participated in another investigational study within the last 1 month prior to entry in this study.
结局指标
主要结局
To compare the efficacy of Silver Sulfadiazine cream (Nanonized) 0.5% w/w with Silverex cream 1% w/w in the prophylaxis of infection in burn wounds
时间窗: At the end of 7±2, 14±2 and 21±2 days
次要结局
- To compare the safety and tolerability of Silver Sulfadiazine cream (Nanonized) 0.5% w/w with Silverex cream 1% w/w in the prophylaxis of infection in burn wounds(At the end of 7±2, 14±2 and 21±2 days)
研究者
研究点 (29)
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