Actively Recruiting

Age: 18Years +
All Genders
ID07359651

Factors Associated With In-hospital Mortality in Necrotizing Soft Tissue Infections A Multicenter Retrospective Cohort Study FATAL-NSTI Study

Led by University of Cagliari · Updated on 2026-01-22

300

Participants Needed

4

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Cagliari

Lead Sponsor

U

University of Milano Bicocca

Collaborating Sponsor

AI-Summary

What this Trial Is About

Necrotizing soft tissue infections (NSTIs) are rare but life-threatening infections affecting the skin and underlying tissues like fat and fascia. These infections progress rapidly and, despite antibiotics, surgery, and intensive care, still have a high risk of death during hospital stays. Early diagnosis is challenging because initial symptoms can resemble less severe infections, which may delay treatment and worsen outcomes. This observational study aims to identify factors linked to in-hospital death in adult patients with NSTIs by analyzing routine clinical and laboratory data collected at hospital admission. The study does not involve any experimental treatments or changes to usual care. All patients receive standard treatment based on clinical judgment at experienced referral centers following established guidelines. The study focuses on gathering and analyzing data such as patient demographics, vital signs, and standard blood tests obtained during early hospital evaluation to find early predictors of mortality. No additional tests or procedures are required specifically for the study. Participants will be adults admitted with a diagnosis of NSTI, including necrotizing fasciitis, Fournier's gangrene, or infections involving the neck or trunk. The research team will review routinely collected clinical information and laboratory results from the initial hospital admission and assessment. The primary outcome measured is death from any cause during the hospital stay within 30 days. The study also looks at limb amputation rates during this period. Data will be used to develop a risk estimation tool to help recognize patients at higher risk early in their hospital course.

CONDITIONS

Brief Title

FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hospital admission with a diagnosis of necrotizing soft tissue infection, including necrotizing fasciitis, Fournier's gangrene, or infections involving the neck or trunk
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 30 days from hospital admission

Participants who undergo routine care are observed using clinical and laboratory data collected during their hospital admission and initial clinical assessment.

Data collected during standard medical and surgical care visits

Trial Site Locations

Total: 4 locations

1

Cagliari University Hospital "Duilio Casula".

Cagliari, Italy

Actively Recruiting

2

Niguarda Hospital, Trauma team.

Milan, Italy

Actively Recruiting

3

San Gerardo Hospital, Department of Surgery

Monza, Italy

Actively Recruiting

4

Gemelli Hospital, Rome. Department of Surgery.

Roma, Italy

Actively Recruiting

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Research Team

M

Mauro Podda, MD, FACS, Professor of Surgery

V

Valentina Murzi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Frequently Asked Questions

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