Comparative Efficacy, Safety and Tolerability of Silver Sulfadiazine Cream (Nanonized) and Silverex Cream in the Prophylaxis of Infection in Burn Wounds - An Open-label, Randomized, Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Proportion of subjects with wound infection during the study treatment period
研究概览
简要总结
This study is a randomized, open-label, comparative, pilot study. Objective of this study is to collect data for selection of a suitable strength of silver sulfadiazine cream (Nanonized) for future pivotal study.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
After screening, eligible patients will be randomized to one of the three topical antimicrobial treatment groups i.e, Silver sulfadiazine cream nanonized (0.5%), Silver sulfadiazine cream nanonized (0.75%) & Silverex cream 1%. The cream will be applied once daily in case of closed dressings & twice daily in case of open dressings.
Treatment with study medication will be continued until the wound(s) heal or upto day 21, whichever is earlier. All subjects will be called for a safety followup assessment on day 42.
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
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who have given written informed consent to participate in the study.
- •Subjects of either sex aged between 18 and 65 years (both inclusive) with partial thickness burns of thermal origin covering 10% of the TBSA and suitable for outpatient management.
- •Subjects in whom burn injury is 24 hours old at the time of screening.
- •Subjects with clean, non-infected wound as judged by the investigator.Presence of infection will be judged clinically by symptoms and signs that include purulent drainage, erythema, warmth, exudation, malodor, pain and/or fever.
排除标准
- •1.Subjects with history of hypersensitivity to silver sulfadiazine, other sulfonamides, chlorhexidine or any of the excipients of study formulations#.
- •2.Subjects with burn wounds associated with chemical, electrical or inhalational injury.
- •3.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).
- •5.Subjects with burns of hands or feet likely to cause functional impairment.
- •6.Subjects with burn wounds not expected to heal within 21 days or requiring systemic antimicrobial treatment or surgical intervention (except surgical debridement) during the study.
- •7.Subjects with burn wounds expected to heal in less than 7 days.
- •8.Subjects with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity and mortality.
- •9.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.
- •10.Subjects who are under treatment with topical or systemic steroid medications or immunosuppressive agents.
- •11.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.
结局指标
主要结局
Proportion of subjects with wound infection during the study treatment period
时间窗: from day 1 to day 21 i.e during the study treatment period
次要结局
- Proportion of subject achieving complete wound closure(Day 14, 7 & 21)