A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 23
- 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 the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic 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 and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation
A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.
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 take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator 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 chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
- •Subjects that will be capable and willing to comply with protocol instructions
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
- •Known allergy/hypersensitivity to the dressing or its components.
- •Known pregnancy or planning to become pregnant or lactation at time of study participation.
- •Participation in another investigative drug or device trial currently or within the last 30 days Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use
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
- Percentage change in wound area(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))
- Wound progress(28 days)
- Quality of life assessed using Numeric Rating Scale (NRS)(28 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))
- Global satisfaction(28 days)
- Percentage change in wound volume(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))
- Alarms(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Absolute change in wound area(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Absolute change in wound volume(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Exudate nature(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Exudate odor(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))
- Tissue type(Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days))
- Exudate amount(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)
- Compliance(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))
- Ability to absorb and/or transport exudate via clinical judgement(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))