Factors linked to in-hospital death in necrotizing soft tissue infections
Official title: 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).
Run by University of Cagliari · NCT07359651 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Cagliari Academic / other |
| Locations | 4 sites (Cagliari and 3 other locations) |
| Status | Recruiting |
| Started | January 1, 2020 |
| Main results expected | March 31, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07359651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Real-time detection of necrotizing soft tissue infection using indocyanine green imaging
We will test whether injecting indocyanine green and tracking its fluorescence over time can quickly and accurately detect necrotizing soft tissue infections in adults suspected of having NSTI.
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Irrigating versus traditional negative-pressure wound therapy for necrotizing soft tissue infections
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.