CTRI/2021/12/038436已完成4 期
A randomized-controlled, open label, two arm study to evaluate safety and efficacy of a New antimicrobial wound dressing (VELVERT) compared to the Standard dressing (SD) in infected wound.
Datt Mediproduct Pvt Ltd0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Subject with cellulitis, necrotizing fasciitis, venous ulcer, and bedsores.
- •2. Subjects with Infected wounds with or without trauma.
- •3. Male and female of age group between 18 to 70 years (Adult, Older Adult).
- •4. Subjects must be able to read and understand informed consent and sign the informed consent to provide data for the study.
- •5. Subjects who allow their data to be collected for the study at predefined follow-up
排除标准
- •Subject unwilling or unable to comply with the follow up visits necessary for data
- •collection.
- •2. Subject found positive for HIV and HPV.
- •3. Concurrent participation in another clinical trial that involves an investigational
- •drug or dressing that would interfere with This Study.
- •4. Pregnant females.
- •5. Subjects with osteomyelitis of the underlying bone.
- •6. Subject with Immunosuppression, corticosteroids or chemotherapy.
- •7. Subject with Diabetic foot ulcer and/or burn.
- •8. Patient with a severe comorbid disorder, not expected to survive more than
研究者
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