CTRI/2014/11/005188
Completed
Phase 3
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 â?? A Double-Blind, Randomized, Pivotal Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Prophylaxis of Infection in Burn Wounds
- Sponsor
- Sun Pharmaceutical Industries Limited
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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
- •2\. 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.
- •3\. Subjects in whom burn injury is less than 24 hours old at the time of screening.
- •4\. Subjects with clean, non\-infected wound as judged by the investigator.
Exclusion Criteria
- •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).
- •4\. Subjects with burns involving genitalia, head (including face) or perineum
- •5\. Subjects with burns of hands or feet or major joints likely to cause functional impairment.
- •6\. Subjects with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity and mortality.
- •7\. 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.
- •8\. Subjects who are under treatment with topical or systemic steroid medications or immunosuppressive agents.
- •9\. 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 subjectâ??s ability to participate in the study.
- •10\. Subjects with history of glucose\-6\-phosphate dehydrogenase deficiency.
Outcomes
Primary Outcomes
Not specified
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