Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Hospital del Mar Research Institute (IMIM) | OTHER |
| Hospital del Mar | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Necrotizing Soft Tissue Infection | This is a prospective, multicenter, observational cohort study of adults (≥18 years) with necrotizing soft-tissue infection (NSTI), defined by surgical/histopathological confirmation or imaging evidence of fascial gas. Participants receive standard care; no interventions are mandated. Data collection includes timing and extent of debridement, antimicrobial regimens, and adjunctive therapies (e.g., intravenous immunoglobulin, hyperbaric oxygen, negative pressure wound therapy), as well as critical care support. Primary outcome is 90-day all-cause mortality; secondary outcomes include organ failure-free days, complications, and 90-day patient-reported outcome measures (PROMs) using EQ-5D-5L. Subgroup analyses will examine variations in practice and outcomes (e.g., immunocompromised status, Fournier's gangrene). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 90-day all-cause mortality | 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. | 90 days from admission |
| Measure | Description | Time Frame |
|---|---|---|
| Organ failure-free days within first 30 days | Number of days alive and free from mechanical ventilation, vasopressors, or renal replacement therapy within 28 days from admission. | 30 days from admission |
| Hospital and ICU length of stay |
Not provided
Inclusion Criteria:
Age ≥18 years
Diagnosis of necrotizing soft-tissue infection (NSTI) confirmed by:
Admitted to a participating hospital during the enrollment period
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults aged 18 years or older admitted to participating hospitals with a confirmed diagnosis of necrotizing soft-tissue infection (NSTI). The diagnosis must be based on surgical or histopathological evidence of fascial necrosis, or radiologic confirmation (e.g., gas in the fascial plane). Patients will be enrolled consecutively over a 6-month window at each site. The study includes diverse international centers in all over the world.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary A Bass, MD PhD | University of Pennsylvania | Study Chair |
| Ana Maria González Castillo, MD PhD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08003 | Spain |
De-identified individual participant data (IPD), including clinical variables and patient-reported outcomes (PROMs), will be available upon reasonable request and approval by the study Steering Committee.
Starting 6 months after publication of primary results, and for a period of 5 years.
Researchers must submit a methodologically sound proposal to the Steering Committee. Approved proposals will require a data use agreement to ensure appropriate use and protection of data.
Not provided
Not provided
| ID | Term |
|---|---|
| D018934 | Fournier Gangrene |
| D018805 | Sepsis |
| D018461 | Soft Tissue Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005832 | Genital Diseases, Male |
Not provided
Not provided
| OTHER |
| University of Birmingham | OTHER |
Not provided
Not provided
Not provided
Number of days from hospital admission to discharge in ICU, including both days. Reported in days, as a continuous variable.
| From admision to ICU to discharge to the ward or death |
| Number and type of reoperations | Number and type of surgical re-interventions performed after the initial debridement, including amputations, repeat debridement, and drainage procedures. | From admission to 90 days |
| Patient-reported quality of life (EQ-5D-5L) | 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. | 60 days from admission |
| Readmission and return to surgery within 90 days | Incidence and reasons for hospital readmissions or return to operating room within 90 days from index admission. | 90 days from admission |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |