CTRI/2024/02/063282进行中（未招募）Unknown
An open label, single-centric, non-randomized clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A study outcome will be considered if below end points meet.
研究概览
简要总结
The study enrolled 20 patients with, "Necrotising soft-tissue infections fasciitis" and were treated with an anti-microbial dressing (VELVERT) for a duration of 60 days. Subjects were evaluated at the scheduled visits.
First subject was enrolled on 16-Apr-2024.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female subjects within the age group of 18 to 70 years (both inclusive).
- •Subject with HbA1c level below 6.5 % (Well-controlled diabetes mellitus)
- •Subject with soft tissue infection caused by trauma, injury, burn, surgery.
- •Subjects with damaged deep layers of your skin that led to necrosis.
排除标准
- •Exclusion Criteria
- •Subject unwilling or unable to comply with the follow up visits necessary for data collection.
- •Subject found positive for HIV, HBsAg and HCV.
- •Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
- •Pregnant females.
- •Subject with Immunosuppression, corticosteroids or chemotherapy.
- •Subject with decision making impairment.
- •Allergies to any material contained investigational devices.
结局指标
主要结局
A study outcome will be considered if below end points meet.
时间窗: 60 days
• Lesion/wound healed by 60 days (2 months) or prior
时间窗: 60 days
• Reduction of wound surface area within a time frame of 60 days (2 months). (Change in wound size)
时间窗: 60 days
次要结局
- • Number of patients achieve a complete wound closure or reduction in wound area by ≥ 50% by 60 days or earlier. (Change in wound area).(• Subject self-assessment of intensity of pain. (Pain scale from 0 to 10))
研究者
Dr Sudhir Kumar
Maharani Laxmi Bai Medical College
研究点 (1)
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