A Prospective, Open, Non-comparative, Post-Market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance® Solo NPWT System in Surgically Closed Incisions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 主要终点
- Change in wound remaining closed
研究概览
简要总结
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).
详细描述
The ASOLO-SCI investigation is designed as a prospective, open, non-comparative, PMCF study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the IfU in up to 34 patients (n=34).
The ASOLO-SCI investigation is a multicentre study that is expected to take place in approximately three European centres.
The study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study Subjects withdraw their consent, or shall the Principal Investigator and clinical team deem the Avance® Solo NPWT System to be no longer adequate for the study Subject's wound. Following termination of Subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment.
As a primary endpoint, the Principal Investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at Day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 of age.
- •Signed written Informed Consent Form.
- •Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
- •Study subjects that are deemed capable and willing to comply with the 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 breastfeeding 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 remaining closed
时间窗: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
The evaluation of the wound remaining closed is captured through an assessment by the Principal Investigator/clinical team from baseline to the final visit (wound remaining closed yes/no).
次要结局
- Wound progress to baseline(Day 14 (+0/-2 days))
- Change in lack of dermal opposition(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Change in exudate amount(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Pain assessment(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Change in wound progress across visits(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Change in exudate odour(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- System wear time(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Sounding of alarms(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Subject compliance(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Global satisfaction(Day 14 (+0/-2 days))
- Change in exudate nature(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Absorption and transportation of exudate(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Product consumption(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Subject quality of life assessment(Day 14 (+0/-2 days))
- Change in peri-wound conditions(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Trauma to the wound's surrounding skin(Day 7 (+0/-2 days), Day 14 (+0/-2 days))
- Ease of application and removal of the Avance® Solo NPWT System(Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days))