A Dual-center Study 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
- 25
- 试验地点
- 4
- 主要终点
- Goal of therapy: Change in granulation tissue
研究概览
简要总结
The purpose of this study is to 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 is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes 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
- Decrease in edema/periwound swelling
- 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
- •Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema
- •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 follow up (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
Goal of therapy: Change in granulation tissue
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached
Goal of therapy: Change in wound volume
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and length, width and depth of the wound measured during treatment until goal of the therapy is reached
Goal of therapy: 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
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached
Goal of therapy: Change in size of the tunneling area
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached
Goal of therapy: Change in size of undermining
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached
Goal of therapy: Change in amount of slough
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached
Goal of therapy: Change in edema/periwound swelling
时间窗: Up to 4 week study duration
Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached
次要结局
- Evaluate the ease of use from clinicians(Up to 4 week study duration)
- Evaluate overall satisfaction from clinicians(Up to 4 week study duration)