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
- 2
- 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.
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)