To Evaluate the Outcomes After Surgery for Necrotizing Soft Tissue Infections- A Prospective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- 30-day mortality. (Short term )
研究概览
简要总结
There is significant mortality associated with necrotizing soft tissue infections, it is imperative to decrease mortality and complications associated with this disease is determined. To accomplish this goal, study team will create a prospectively maintained database of all NSTI patients admitted at department of surgery. Investigators will asses the predictors of poor outcome and follow these patients for 1 year in clinic and asses the functional quality of life by incorporating 36-Item Short Form Survey (SF-36) score.
详细描述
RATIONALE AND BACKGROUND Necrotizing soft tissue infections (NSTIs) are severe life-threatening, rapidly-spreading, soft tissue infections of the subcutaneous tissue, fascia, or muscle caused by bacteria. Due to the rapid progression of disease, early diagnosis and treatment are crucial to a patient's survival.
Given the aggressive nature of these infections and the significant mortality associated with them, it is imperative that the optimal standard of care to decrease mortality and complications associated with this disease is determined. To accomplish this goal, study team will create a prospectively maintained database of all NSTI patients admitted at department of surgery. Investigators will follow these patients for 1 year in clinic and asses the functional quality of life by incorporating 36-Item Short Form Survey (SF-36) score. This RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It is a validated scale freely available for research to assess the quality of life after surgery.
Primary Objectives:
The short term objectives are to evaluate 30-day mortality and to establish the predictors of poor outcome. The long term objectives are to measure quality of life after NSTI.
CHARACTERISTICS OF THE STUDY POPULATION
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients ≥ 18 years presenting with necrotizing soft tissue infections admitted to Westchester Medical Center, who will undergo surgical management
排除标准
- •Age < 18 years.
结局指标
主要结局
30-day mortality. (Short term )
时间窗: 30 days
The short term objectives are to evaluate 30-day mortality.
次要结局
- The quality of life survey (Long Term)(1year)
研究者
Rifat Latifi
The Felicien Steichen Professor and Chairman of Surgery
New York Medical College