CTRI/2020/12/029698已完成Unknown
A randomized, open label, single centre, post market clinical study (PMS) to evaluate the efficacy and safety of a new antimicrobial wound dressing (VELVERT) compared to Silver Sulfadiazine in the treatment of second degree burn wounds.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- (i)Evaluation of total wound area (sum of areas of all present wounds on both limbs) has completely closed, compared to baseline (inclusion), on or before the scheduled last visit (Day 24)
研究概览
简要总结
To assess the efficacy of a new antimicrobial wound dressing (VELVERT) to treat second degree burn wounds compared to Silver Sulfadiazine in terms of healing rates based on clinical evaluation and wound photographs analysis.
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
- •1.Adult non-diabetic male and female subjects of the age group between 18 to 70 years.
- •2.Subjects with second-degree burn wounds 3.Total Body Surface Area of burns 5% to 20% 4.Subjects/ LAR 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 periods
- •All sexually active female subjects of childbearing potential without any clinical evidence of pregnancy.
排除标准
- •1.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
- •2.Subjects found positive for HIV and HCV 3.Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study 4.Pregnant females 5.Comorbidities which could interfere with clinical evaluations or interpretation of results 6.Subjects with known allergy to the constituents of investigational products/ device.
- •7.Subjects with immunosuppression, corticosteroids or chemotherapy 8.Subjects with a severe comorbid disorder, not expected to survive more than 12 months.
- •9.Subjects requiring concomitant use of negative pressure wound therapy (NPWT) on the reference wound 10.Poor adaptivity or seriously ill subjects who cannot finish the observation period 11.Any other condition which, according to the judgment of the investigator, could interfere in the study 12.Subjects with Diabetic foot ulcer and Infected wound.
结局指标
主要结局
(i)Evaluation of total wound area (sum of areas of all present wounds on both limbs) has completely closed, compared to baseline (inclusion), on or before the scheduled last visit (Day 24)
时间窗: 24 days
(ii)Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visit
时间窗: 24 days
次要结局
- 1.Comparative evaluation of the number of complete wound closures by day 24(2.Number of subjects reporting relief from pain)
研究者
研究点 (1)
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