NCT01339429已完成1 期
Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Maintenance of Negative Pressure
研究概览
简要总结
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.
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
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •open wound appropriate for NPWT
- •wound size greater than 2 cm2 and less than 150 cm2
- •adequate adjacent intact skin for application of sNPWT
- •adequate contour of wound location for application of sNPWT
- •patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
- •the patient is expected to remain clinically stable for the duration of the study
- •the patient is to remain hospitalized for the duration of the study
- •patient or their legal representative is willing and able to sign an IRB-approved informed consent
- •patient less than 21 years old is willing to sign an approved assent form if able to sign
排除标准
- •exposed blood vessels
- •ischemic wound
- •wound with necrotic tissue requiring further debridement at the time of enrollment
- •infection
- •acute osteomyelitis
- •malignancy in the wound
- •latex or rubber containing product sensitivity
结局指标
主要结局
Maintenance of Negative Pressure
时间窗: 3 days
The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.
次要结局
- Number of Participants With Serious Adverse Events(3 days)
研究者
Robert Riviello
Instructor in Surgery
Brigham and Women's Hospital
研究点 (2)
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