Fournier Gangrene, Necrotizing Soft Tissue Infection, Sepsis, Soft Tissue Infections, Surgical Infection
Conditions
Keywords
diagnosis, management, microbiology, patient related outcome measures, outcomes, NSTI, Necrotizing Soft Tissue Infection, Fournier Gangrene, Soft Tissue Infection, Severe Skin and Soft Tissue Infection, Debridement, Sepsis, Snapshot Audit
Brief 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.
Interventions
None listed
Sponsors
University of Pennsylvania
Hospital del Mar Research Institute (IMIM)
Hospital del Mar
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
University of Birmingham
European Society for Trauma and Emergency Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day all-cause mortality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ failure-free days within first 30 days | 30 days from admission | Number of days alive and free from mechanical ventilation, vasopressors, or renal replacement therapy within 28 days from admission. |
| Hospital and ICU length of stay | From admision to ICU to discharge to the ward or death | Number of days from hospital admission to discharge in ICU, including both days. Reported in days, as a continuous variable. |
| Number and type of reoperations | From admission to 90 days | Number and type of surgical re-interventions performed after the initial debridement, including amputations, repeat debridement, and drainage procedures. |
| Patient-reported quality of life (EQ-5D-5L) | 60 days from admission | Self-reported health status at 60 days after admission using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. This includes five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a 5-point scale (1 = no problems; 5 = extreme problems). The score varies from 5 to 25 points. |
| Readmission and return to surgery within 90 days | 90 days from admission | Incidence and reasons for hospital readmissions or return to operating room within 90 days from index admission. |
Countries
Spain
Outcome results
None listed