A randomized-controlled, open label, two arm post market clinical study to evaluate safety and efficacy of a new antimicrobial wound dressing (VELVERT) compared to the standard dressing. (SD) in infected wound.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- An FHO is considered to have occurred in a given patient if all the following composite endpoints are met:
研究概览
简要总结
A new anti microbial dressing is been tested in comparison with the standard available dressing. As per the current practice, Framycetin cream 1%w/w ointment is been used for dressing in infected wounds. the participant would be treated with either the standard dressing (SD) or the investigational new anti- microbial dressing VELVERT as the randomization schedule.
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.Male and female of age group between 18 to 70 years (Adult, Older Adult).
- •2.Subjects must be able to read and understand informed consent, and sign the informed consent to provide data for the study.
- •3.Subjects who allow their data to be collected for the study at predefined follow-up periods.
- •4.Female subject that is willing to take contraceptive pills for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment.
- •5.Subjects suffering from infected wound with size more than 25/30 square centimeter.
- •6.Subjects having a traumatic infected wound with duration less than 1 month.
排除标准
- •1.Subject unwilling or unable to comply with the follow up visits necessary for data collection.
- •2.Subject found positive for HIV, HBsAg 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.Subject with Immunosuppression, corticosteroids or chemotherapy.
- •6.Subject with decision making impairment.
- •7.Subject with a severe comorbid disorder, not expected to survive more than 12 months.
- •8.Diabetic foot infections.
- •9.Allergies to any material contained investigational devices.
- •10.Subjects with burn wounds, DFU, malignant ulcers, tubercular ulcers, leprotic ulcers, gangrenous ulcers, ischemic ulcers, bed sores.
- •11.Any other condition which, according to the judgment of the investigator, could interfere in the study.
结局指标
主要结局
An FHO is considered to have occurred in a given patient if all the following composite endpoints are met:
时间窗: (Day 24).
III.Evaluate bacterial load before (Day 0), Day 8, Day 16 and on the last day (Day 24).
时间窗: (Day 24).
Number of dressings and time required (in days) to achieve complete wound closure. Healing is based on Favorable healing outcome (FHO) at a time frame of 24 days.
时间窗: (Day 24).
I.Total wound area (sum of areas of all present wounds on both limbs) has decreased, compared to baseline (Screening), by 100% at or before the scheduled last visit.
时间窗: (Day 24).
II.Comparative evaluation of wounds through Bates-Jensen Wound Assessment Tool and assessment of wound photographs at each visit.
时间窗: (Day 24).
次要结局
- i.Comparative evaluation of wound infection during the study period assessed through TLC and DLC evaluation.(ii.Comparative evaluation of each of the observation used to define FHO at time frame of 24 days.)