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.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of dressings and time required (in days) to achieve complete wound closure.
研究概览
简要总结
The study is been conducted to assess the efficacy of a new anti-microbial wound dressing (VELVERT) with the standard dressing used (Paraffin gauze dressings) in an infected wound on the basis of its healing rate on clinical evaluation and wound photograph 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
- •Subject with cellulitis, necrotizing fasciitis, venous ulcer, and bedsores.
- •Subjects with Infected wounds with or without trauma.
- •Male and female of age group between 18 to 70 years (Adult, Older Adult).
- •Subjects must be able to read and understand informed consent and sign the informed consent to provide data for the study.
- •Subjects who allow their data to be collected for the study at predefined follow-up periods.
排除标准
- •Subject unwilling or unable to comply with the follow up visits necessary for data collection.
- •Subject found positive for HIV and HPV.
- •Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with This Study.
- •Pregnant females.
- •Subjects with osteomyelitis of the underlying bone.
- •Subject with Immunosuppression, corticosteroids or chemotherapy.
- •Subject with Diabetic foot ulcer and/or burn.
- •Patient with a severe comorbid disorder, not expected to survive more than 12 months.
结局指标
主要结局
Number of dressings and time required (in days) to achieve complete wound closure.
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
Healing is based on Favorable healing outcome (FHO) at a time frame of 24 days from
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
the first application of dressing.
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
FHO is considered to have occurred in a given patient if all the following composite
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
endpoints are met:
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
i) Total wound area (sum of areas of all present wounds on both limbs) has
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
decreased, compared to baseline (Screening), by 100% at or before the scheduled
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
last visit.
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
ii) Comparative evaluation of wounds through Bates-Jensen Wound Assessment
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
Tool and assessment of wound photographs at each visit.
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
iii) Comparative evaluation of wound infection during the study period assessed
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
through TLC and DLC evaluation.
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
iv) Visual Analogue scale for pain assessment
时间窗: Schedule mentioned in the protocol up to 24 days from | the first application of dressing
次要结局
- i) Comparative evaluation of each of the observation used to define FHO at time frame of 24 days from the first application of dressing. ii) Comparative evaluation of the number of complete wound closures. iii) Number of local cares requiring instrumental debridement (surgical or sharp debridement) in 24 days duration. iv) Number of subjects reporting relive from pain Comparative evaluation of Subject pain level based on a 0 10 Numeric Pain Chart on each dressing day and its final removal (0 no pain, 10 worst pain imaginable). They will be instructed to share the medication name, dosage, and number of pills if they are given analgesics for pain relief. v) Assessment of infection level Comparative evaluation of Subject for their infection level based on TLC & DLC value.(24 days from the first dressing application.)