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

NCT07359651 | Recruiting

• 1 other identifier: FATAL-NSTI_UniCa_2025.
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

Necrotizing soft tissue infections (NSTIs) are rare but potentially life-threatening infections involving the skin and underlying tissues such as fat, fascia, and sometimes muscle. They can progress rapidly and, despite modern antibiotics, surgery, and intensive care, are still associated with high in-hospital mortality. A major challenge in the management of NSTIs is early diagnosis. Initial signs and symptoms are often nonspecific and may resemble less severe soft tissue infections, leading to diagnostic and therapeutic delays. Once identified, treatment requires urgent surgery, broad-spectrum antibiotics, and close monitoring, frequently in an intensive care setting. Even with appropriate treatment, the clinical course of NSTIs is highly variable. Some patients recover, while others develop severe complications such as septic shock or multiple organ failure and may die during hospitalization. Predicting outcomes early in the hospital stay remains difficult for clinicians. The aim of this observational study is to identify factors associated with in-hospital mortality in adult patients with NSTIs. In-hospital mortality, defined as death from any cause during the hospital stay for NSTI treatment, represents the most severe outcome and is of major relevance to patients and caregivers. The study focuses on clinical and laboratory data routinely available at hospital admission or during initial emergency department evaluation. These include patient demographics, vital signs, and standard blood test results commonly obtained in early clinical assessment. No additional diagnostic tests or procedures are required for study purposes. Identifying early predictors of mortality is particularly important in NSTIs, given the rapid progression of the disease. Early recognition of high-risk patients may allow closer monitoring and more timely interventions. The study will be conducted in high-volume referral centers with extensive experience in NSTIs management, where care is delivered according to established international guidelines. All patients will receive standard treatment based on clinical judgment. No experimental therapies or changes in routine care will be involved.

Conditions

Necrotizing Fascitis; Fournier Gangrene; Fournier's Gangrene; Soft Tissue Infections

Keywords

Necrotizing soft tissues infections; NSTI; Necrotizing fasciitis; Fournier's gangrene

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Death from any cause occurring during the index hospitalization for necrotizing soft tissue infection.

  30 days from hospital admission.

Secondary Outcomes (1)

• Limb amputation (upper or lower extremity)

  30 days from hospital admission.

Study Arms (4)

Patients with Necrotizing Soft Tissue Infections.

Adult patients admitted with a diagnosis of necrotizing soft tissue infection, diagnosed based on clinical findings, imaging when available, and/or intraoperative assessment.

Other: No Intervention: Observational Cohort

Necrotizing Fasciitis

Patients with necrotizing infection primarily involving the fascia and surrounding soft tissues, diagnosed based on clinical findings, imaging when available, and/or intraoperative assessment.

Other: No Intervention: Observational Cohort

Fournier's Gangrene

Patients with necrotizing infection involving the perineal, genital, or perianal region, consistent with Fournier's gangrene.

Other: No Intervention: Observational Cohort

Necrotizing Soft Tissue Infections of the Neck and Trunk

Patients with necrotizing soft tissue infections involving the cervical region or the trunk, including thoracic and abdominal wall locations.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No experimental intervention, treatment assignment, or change in clinical management is performed as part of the study. All patients receive standard medical and surgical care according to local institutional protocols and current clinical practice guidelines. Diagnostic and therapeutic decisions are made solely by the treating clinical teams and are not influenced by participation in the study.

Fournier's Gangrene; Necrotizing Fasciitis; Necrotizing Soft Tissue Infections of the Neck and Trunk; Patients with Necrotizing Soft Tissue Infections.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients admitted to the participating high-volume tertiary referral academic hospitals in Italy with a diagnosis of necrotizing soft tissue infection. Patients are managed according to standard clinical practice by experienced multidisciplinary teams, including emergency surgeons, trauma surgeons, and critical care specialists. The population includes patients affected by different forms of necrotizing soft tissue infections, such as necrotizing fasciitis, Fournier's gangrene, and necrotizing infections involving the neck or trunk. All patients are evaluated and treated during the index hospitalization, and clinical data are collected as part of routine medical care. Only information available at the time of hospital admission or during the initial clinical assessment is used for analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Milano Bicocca: collaborator
• University of Milan: collaborator
• Università Cattolica del Sacro Cuore, Rome, Italy: collaborator
• University of Cagliari: lead
• University of Cagliari, Cagliari, Italy: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Fasciitis, Necrotizing; Fournier Gangrene; Soft Tissue Infections

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Adolfo Pisanu, MD

  University of Cagliari

  STUDY DIRECTOR

Central Study Contacts

Mauro Podda, MD, FACS, Professor of Surgery

CONTACT

+39 07051096571; mauro.podda@unica.it

Valentina Murzi, MD

CONTACT

+39 07051096571; valentina.murzi@unica.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 22, 2026
• Study Start: January 1, 2020
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)