SKin and soft tissue necrotizing INfections in the Intensive Care Unit: a prospective multi-national cohort study (SKIN-ICU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Mortality at day 90
研究概览
简要总结
Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The current study (SKIN-ICU) is a multinational prospective non-interventional cohort study that will include patients admitted to the intensive care units (ICU) for NSTI. The primary outcome is mortality at 90 days. Secondary outcome will includes functional outcome and quality of life at 6 months. This will be largest prospective study on NSTI, and expected to include 1000 patients worldwide including India, over 2 years of study duration.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age > 18 years 2.Patient with surgically-confirmed NSTI (i.e., macroscopic appearance of tissue during surgery revealing swollen, dull gray tissues with a thin, brownish exudate with or without necrosis).
排除标准
- 未提供
结局指标
主要结局
Mortality at day 90
时间窗: 3 months
次要结局
- Six-month mortality(6 months)
- Functional outcomes and HR-QoL at 6 months(6 months)