NCT01417234已完成不适用
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 3M
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Wound Closure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
- •Wound < 16 cm in greatest diameter
- •Subject ≥ 18 years of age
- •Exudate < 25 ml/ day (estimate)
- •Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
- •Subject is willing and able to sign informed consent
排除标准
- •Wound > 45 days old
- •Wound-related cellulitis
- •Wound located in an area not amenable to forming an air-tight seal
- •Subject has untreated osteomyelitis
- •Subject is allergic to wound care products
- •Wound has exposed blood vessels not suitable for negative pressure therapy
- •Subject is pregnant
- •Subject is actively participating in other clinical trials that conflict with current study
- •Subject has fistulas
结局指标
主要结局
Wound Closure
时间窗: 12 weeks
Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant
次要结局
- Percent Wound Size Change(8 weeks and 12 weeks)
研究者
研究点 (1)
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