A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute (Traumatic Wounds and Flaps and Grafts), as Well as Subacute (e.g., Dehisced Wounds) Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- Change in wound progress
研究概览
简要总结
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the Instructions for Use, for up to 28 days.
详细描述
This investigation is designed as a prospective, open, non-comparative, PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). This is a multi-center study that will take place in approximately 5 European countries. The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System, for up to 28 days.
Treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days).
The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will be assessed at each follow-up visit and measured by three outcomes:
- Deteriorated
- No change
- Improved
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female ≥ 18 years.
- •Signed written informed consent.
- •Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use
排除标准
- •Known malignancy in the wound or margins of the wound
- •Untreated and previously confirmed osteomyelitis
- •Non-enteric and unexplored fistulas
- •Necrotic tissue with eschar present
- •Exposed nerves, arteries, veins or organs
- •Exposed anastomotic site
- •Subjects with known allergies/hypersensitivity to product components.
- •Known pregnancy or planning to become pregnant or lactation at the time of study participation.
- •Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
- •Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.
结局指标
主要结局
Change in wound progress
时间窗: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wound progress compared to last visit and assessed as: * Deteriorated * No change * Improved
次要结局
- Wound progress(28 days)
- Tissue type(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Trauma(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Exudate(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Peri-wound(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Absorb and transport of exudate(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Wear time(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Global satisfaction(28 days)
- Wound dimension(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Pain assessment(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Graft take(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Ease of application(Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Compliance(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Tissue in-growth(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed)
- Flap survival(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Alarms(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Product consumption(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Quality of life assessment(28 days)