Necrotizing Soft Tissue Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Necrotizing Soft Tissue Infection, Fournier Gangrene, Sepsis, Surgical Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SnapNSTI: An International Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Necrotizing Soft Tissue Infections
Overview
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.
Primary outcome measures
- 90-day all-cause mortality [Time frame: 90 days from admission]
Secondary outcome measures (5)
- Organ failure-free days within first 30 days [Time frame: 30 days from admission]
- Hospital and ICU length of stay [Time frame: From admision to ICU to discharge to the ward or death]
- Number and type of reoperations [Time frame: From admission to 90 days]
- Patient-reported quality of life (EQ-5D-5L) [Time frame: 60 days from admission]
- Readmission and return to surgery within 90 days [Time frame: 90 days from admission]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Non Severe soft-tissue infection
- Patients <18 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital del Mar — Barcelona
Identifiers
NCT: NCT07107555 · SnapNSTI