Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds
研究概览
简要总结
Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
详细描述
The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds when using the Medela Invia Motion Endure NPWT system during 4-week study duration.
Goal of therapy will be defined by the physician according to initial assessment:
Endpoints (dependent on goal of therapy):
- Decrease in wound volume
- Decrease in size of the tunneling area
- Decrease in size of undermining
- Decrease in amount of slough
- Increase in granulation tissue
- The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.
**Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented**
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
- •Adult subjects ≥18 years of age.
- •Signed, informed consent by patient or LAR within 72 hours of admission to burn center.
- •Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
- •Patient is comfortable (e.g. not in pain)
- •Patient is willing and able to adhere to treatment protocol.
排除标准
- •Patient not willing to comply with f/u clinic visits.
- •Subjects with
- •Necrotic tissue with eschar present
- •Untreated osteomyelitis
- •Non-enteric and unexplored fistulas
- •Malignancy in wound
- •Exposed vasculature
- •Exposed nerves
- •Exposed anastomotic site of blood vessels or bypasses
- •Exposed organs
- •Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives.
研究组 & 干预措施
Invia Motion Endure
干预措施: Invia Motion Endure (Device)
结局指标
主要结局
Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds
时间窗: 4 weeks
Goal of the therapy will be defined by the physician according to initial assessment: * Decrease in wound volume * Decrease in size of the tunneling area * Decrease in size of undermining * Decrease in amount of slough * Increase in granulation tissue * The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft. \*\*Study endpoint will be determined by physician at the time of enrolment, when the goal of therapy is documented\*\*
次要结局
- Evaluation of ease of use and satisfaction(4 weeks)