Factors linked to in-hospital death in necrotizing soft tissue infections
Factors Associated With In-hospital Mortality in Necrotizing Soft Tissue Infections. A Multicenter Retrospective Cohort Study. FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).
This project will try to identify early clinical and laboratory signs at hospital admission that predict which adults with necrotizing soft tissue infections are at highest risk of dying in hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cagliari Academic / other |
| Locations | 4 sites (Cagliari and 3 other locations) |
| Trial ID | NCT07359651 on ClinicalTrials.gov |
What this trial studies
This observational multicenter cohort collects routine clinical and laboratory data from adults admitted with necrotizing soft tissue infections at four tertiary referral hospitals in Italy. Investigators will analyze information available at hospital admission to identify factors associated with in-hospital mortality. The cohort includes necrotizing fasciitis, Fournier's gangrene, and other NSTIs of the neck or trunk, and excludes patients transferred before outcome assessment or with missing primary outcome data. The aim is to produce practical early risk indicators that clinicians can use during initial evaluation to guide monitoring, resource allocation, and treatment intensity.
Who should consider this trial
Good fit: Adults aged 18 or older admitted with a confirmed necrotizing soft tissue infection (including necrotizing fasciitis or Fournier's gangrene) at one of the participating hospitals are the intended participants.
Not a fit: Children under 18, patients with non-necrotizing skin or soft tissue infections, patients transferred to another hospital before completion of care, and those with missing outcome data are unlikely to benefit from this analysis.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify high-risk patients earlier so they can prioritize urgent surgery, intensive monitoring, and targeted resources to reduce deaths.
How similar studies have performed: Prior single-center studies and scoring tools (for example LRINEC) have reported mixed performance in predicting outcomes for NSTI, so multicenter data are needed to improve reliability.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Hospital admission with a diagnosis of necrotizing soft tissue infection, including: Necrotizing fasciitis, Fournier's gangrene, Necrotizing soft tissue infections involving the neck or trunk. Exclusion Criteria: * Age younger than 18 years * Patients with non-necrotizing skin or soft tissue infections * Patients transferred to another hospital before completion of treatment or outcome assessment * Missing data for the primary outcome (in-hospital mortality)
Where this trial is running
Cagliari and 3 other locations
- Cagliari University Hospital "Duilio Casula". — Cagliari, Italy (Recruiting)
- Niguarda Hospital, Trauma team. — Milan, Italy (Recruiting)
- San Gerardo Hospital, Department of Surgery — Monza, Italy (Recruiting)
- Gemelli Hospital, Rome. Department of Surgery. — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Mauro Podda, MD, FACS, Professor of Surgery
- Email: mauro.podda@unica.it
- Phone: +39 07051096571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.