Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score
试验速览
- 阶段
- 不适用
- 入组人数
- 1,010
- 试验地点
- 1
- 主要终点
- mortality length of time in hospital
研究概览
简要总结
Primary Objective:
The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection.
Secondary Objectives:
To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.
详细描述
This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI
排除标准
- •Age <18 years old and age > 89 years
- •Pregnancy
- •Prisoners
- •Below ankle diabetic foot infections complicated by peripheral vascular disease
- •Burn wounds
结局指标
主要结局
mortality length of time in hospital
时间窗: 30-90 days
Change in the presence of necrosis
时间窗: up to 30 days
thrombosed vessels or absence of bleeding
次要结局
未报告次要终点