NCT07107555

Necrotizing Soft Tissue Infections

SnapNSTI: An International Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Necrotizing Soft Tissue Infections

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 480 (estimated)
• Sponsor: European Society for Trauma and Emergency Surgery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Necrotizing Soft Tissue Infection
• Fournier Gangrene
• Sepsis
• Surgical Infection
• Soft Tissue Infections

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

1 site across 1 country: Spain