SnapNSTI: An International Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Necrotizing Soft Tissue Infections
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- 90-day all-cause mortality
研究概览
简要总结
SnapNSTI is an international, multicenter, time-bound prospective observational cohort study designed to characterize current epidemiology, management patterns, and outcomes of patients with necrotizing soft-tissue infections (NSTI). The primary objective is to estimate 90-day all-cause mortality and to evaluate the variability in management across centers. The study will also explore the association between clinical characteristics, treatments, and patient-reported outcomes.
详细描述
Necrotizing soft-tissue infections (NSTIs) are life-threatening surgical emergencies with high mortality despite timely surgical debridement and antibiotic treatment. Wide variability in treatment strategies-ranging from diagnostic imaging to operative timing and adjunctive therapies-contributes to outcome heterogeneity, yet no standardized, high-resolution prospective data exist to guide best practices.
SnapNSTI is a time-bound, multicenter international observational cohort study coordinated by the Center for Emergency Surgery Outcomes Research (CESOR) at the University of Pennsylvania, and led by a consortium of international surgical societies. The study will enroll adult patients with confirmed NSTI over a 6-month window at each participating site within a 12-month period starting in 2026.
The primary outcome is 90-day all-cause mortality. Secondary outcomes include organ support-free days, in-hospital complications, length of stay, and 60-day patient-reported outcomes (PROMs, including the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument). Standardized definitions and real-time REDCap-based data collection will ensure data quality. Analyses will include multivariable regression, propensity score methods, and target trial emulation. Results will inform future interventional research and evidence-based guidelines.
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
- •Age ≥18 years
- •Diagnosis of necrotizing soft-tissue infection (NSTI) confirmed by:
- •Surgical or histopathological evidence of fascial necrosis
- •OR imaging showing gas in the fascial plane
- •Admitted to a participating hospital during the enrollment period
排除标准
- •Non Severe soft-tissue infection
- •Patients <18 years old
结局指标
主要结局
90-day all-cause mortality
时间窗: 90 days from admission
All-cause mortality measured at 90 days from hospital admission in patients with confirmed necrotizing soft-tissue infection (NSTI). Mortality status will be obtained via chart review, clinical follow-up or telephone contact.
次要结局
- Organ failure-free days within first 30 days(30 days from admission)
- Hospital and ICU length of stay(From admision to ICU to discharge to the ward or death)
- Number and type of reoperations(From admission to 90 days)
- Patient-reported quality of life (EQ-5D-5L)(60 days from admission)
- Readmission and return to surgery within 90 days(90 days from admission)
研究者
Ana María González Castillo
Principal Investigator
European Society for Trauma and Emergency Surgery