About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial 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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo 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.
Treatment groups
Trial outcomes
Primary outcomes
In-hospital mortality
Death from any cause occurring during the index hospitalization for necrotizing soft tissue infection.
Secondary outcomes
Limb amputation (upper or lower extremity)
Need for surgical amputation of the upper or lower limb performed during the index hospitalization for necrotizing soft tissue infection.
Sponsors and contacts
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University of Cagliari
Lead sponsor
University of Milano Bicocca
Collaborator
University of Milan
Collaborator
Catholic University of the Sacred Heart
Collaborator