NCT01113658撤回不适用
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 3M
- 试验地点
- 4
- 主要终点
- Frequency of complaints about device use and operation
研究概览
简要总结
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.
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
- •Wound < 10 cm in greatest diameter
- •Patient >18 years of age
- •Willing and able to sign informed consent
排除标准
- •Patients with wound-related cellulitis
- •Patients with thick eschar at wound base post debridement
- •Patients with wounds located in an area not amenable to forming an air- tight seal
- •Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome
- •Patient has untreated osteomyelitis
- •Patient is allergic to wound care products
- •Patient wounds with exposed blood vessels not suitable for negative pressure therapy
- •Pregnant or pregnancy-suspected patients
- •Subject actively participating in other clinical trials that conflict with the current study
结局指标
主要结局
Frequency of complaints about device use and operation
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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