Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Frequency of device-related serious adverse events (SAEs) (all adverse events attributed to the wound and or device will be collected and assessed as non-device related or device related, and serious or non-serious, by the Investigator)
研究概览
简要总结
The main questions the study aims to answer are:
- How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days?
- How safe is the Avelle™ Negative Pressure Wound Therapy System?
详细描述
The goal of this observational study is to gather information about the the Avelle™ Negative Pressure Wound Therapy System in people that have a wound that leaks fluid and is 14 days old or less. The Avelle™ Negative Pressure Wound Therapy (NPWT) System combines a sterile dressing comprising gelling fibre technology to absorb wound exudate with negative pressure applied to the wound via a vacuum pump. The Avelle™ NPWT System consists of a disposable single patient use battery powered pump, absorbent wound dressing, and fixation strips.
Participants will:
- be asked questions about their medical history and medications
- asked to allow the wound and surrounding skin to be examined
- be asked to use the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days
- be asked to review any issues or concerns with the Avelle™ Negative Pressure Wound Therapy System
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age.
- •Subject is willing and able to take part in the study and provide written informed consent.
- •Subject has one target wound which is ≤ 14 days old
- •Subject has target wound that is intended to heal by primary intention
- •Subject has a target wound which is ≤ 25% of the dressing area as per the Instructions For Use
- •Target wound has low to moderate exudate
- •Wound is suitable for treatment with Avelle™ NPWT
- •Subject is deemed capable and willing to comply with the protocol and product instructions.
排除标准
- •Subject has an existing health condition that would compromise their participation and follow-up in this study such as the ability to understand and follow instructions
- •Subject has been treated with another NPWT system during the past 14 days
- •Subject, in the opinion of the Investigator, is not clinically suitable for inclusion
- •Subject is contraindicated for the Avelle™ NPWT System
结局指标
主要结局
Frequency of device-related serious adverse events (SAEs) (all adverse events attributed to the wound and or device will be collected and assessed as non-device related or device related, and serious or non-serious, by the Investigator)
时间窗: Up to 14 days
Primary safety outcome
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).
时间窗: Up to 14 days
Primary performance outcome
次要结局
未报告次要终点