Necrotizing FascitisFATAL-NSTINCT07359651
FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).
An observational study of Necrotizing Fascitis and Fournier Gangrene, run by University of Cagliari at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Fascitis, Fournier Gangrene, Fournier's Gangrene
- How many people
- 300 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jan 2020to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Cagliari University Hospital "Duilio Casula".
Cagliari
Mauro Podda, MD, +39 07051096571, mauro.podda@unica.it
- Recruiting
Niguarda Hospital, Trauma team.
Milan
Tiziana Pilia, MD, + 39 02 6444 3030, tiziana.pilia@libero.it
- Recruiting
San Gerardo Hospital, Department of Surgery
Monza
Marco Ceresoli, MD, + 39 039 233 3651, ceresoli@unimib.it
- Recruiting
Gemelli Hospital, Rome. Department of Surgery.
Roma
Fausto Rosa, MD, +39 0688818881, faustofrosa@unicatt.it
About this study
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).
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.
Read more
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.
Read the detailed description
Necrotizing soft tissue infections (NSTIs) represent a group of rare but extremely severe conditions characterized by rapid progression, extensive tissue destruction, and a high risk of systemic complications. These infections often require surgical management in emergency settings, broad-spectrum antimicrobial therapy, and intensive supportive care. Despite improvements in diagnostic strategies, surgical techniques, and critical care, NSTIs continue to be associated with high in-hospital mortality and substantial morbidity.
The main clinical challenge in the management of these infections is the difficulty in predicting outcomes early in the hospital course. Initial signs and symptoms may be nonspecific and can overlap with those of less severe soft tissue infections. Early risk assessment remains complex, particularly during the first hours after hospital admission, when critical decisions regarding monitoring intensity, resource allocation, and escalation of care must be made.
The present study is designed to improve understanding of factors associated with adverse outcomes in patients with NSTIs by focusing on clinical and laboratory information available at the time of hospital admission. The study aims to identify early indicators of increased risk that can be recognized promptly in everyday clinical practice through the analysis of variables routinely collected during initial evaluation.
The study involves four tertiary referral academic hospitals in Italy, all of which are high-volume centers with extensive experience in the management of NSTIs and other (traumatic and septic) complex surgical emergencies.
Data used for this study are derived from routinely collected clinical information recorded during standard patient care. The dataset includes demographic characteristics, comorbid conditions, physiological parameters, and laboratory test results obtained at hospital admission and during the initial clinical assessment. The selected variables are widely available, rapidly obtainable, and commonly used by clinicians to evaluate patient status at presentation.
The study aims to clarify how combinations of early clinical and laboratory findings are associated with death and other severe in-hospital outcomes.
The study does not seek to influence or modify clinical management but rather to provide prognostic information that may complement clinical judgment.
The analytical approach includes exploratory and confirmatory statistical analyses to assess associations between admission variables and adverse outcomes. Multivariable modeling techniques are used to account for the combined effect of multiple factors and to identify independent predictors of poor outcomes.
The results of the multivariable model will be translated into a graphical risk estimation tool. This tool is intended to provide an intuitive representation of how different admission variables contribute to overall risk.
All data are handled in accordance with applicable ethical standards and data protection regulations. The study uses retrospective data collected during routine care, and appropriate approvals were obtained from institutional authorities at each participating center.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Necrotizing soft tissues infections, NSTI, Necrotizing fasciitis, Fournier's gangrene
- Medical subject headings
- Fasciitis, Necrotizing, Fournier Gangrene, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Intervention: Observational Cohort | |
| Fournier's Gangrene | Patients with necrotizing infection involving the perineal, genital, or perianal region, consistent with Fournier's gangrene. Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death from any cause occurring during the index hospitalization for necrotizing soft tissue infection.
Measured: 30 days from hospital admission.
Secondary outcomes (1)
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.
Measured: 30 days from hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2020
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca, University of Milan, Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Mauro Podda, University of Cagliari
- Investigators
- Adolfo Pisanu, MD, Study director, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359651
- Sponsor's protocol ID
- FATAL-NSTI_UniCa_2025.
- Acronym
- FATAL-NSTI
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data sharing is restricted due to patient confidentiality, data protection regulations, and local institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT07359651
- Acronym / sponsor ID
- FATAL-NSTI / FATAL-NSTI_UniCa_2025.
- Keywords
- Necrotizing soft tissues infections, NSTI, Necrotizing fasciitis, Fournier's gangrene
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- University of Milano Bicocca, University of Milan, Catholic University of the Sacred Heart
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Necrotizing soft tissue infections (NSTIs) represent a group of rare but extremely severe conditions characterized by rapid progression, extensive tissue destruction, and a high risk of systemic complications. These infections often require surgical management in emergency settings, broad-spectrum antimicrobial therapy, and intensive supportive care. Despite improvements in diagnostic strategies, surgical techniques, and critical care, NSTIs continue to be associated with high in-hospital mortality and substantial morbidity.
The main clinical challenge in the management of these infections is the difficulty in predicting outcomes early in the hospital course. Initial signs and symptoms may be nonspecific and can overlap with those of less severe soft tissue infections. Early risk assessment remains complex, particularly during the first hours after hospital admission, when critical decisions regarding monitoring intensity, resource allocation, and escalation of care must be made.
The present study is designed to improve understanding of factors associated with adverse outcomes in patients with NSTIs by focusing on clinical and laboratory information available at the time of hospital admission. The study aims to identify early indicators of increased risk that can be recognized promptly in everyday clinical practice through the analysis of variables routinely collected during initial evaluation.
The study involves four tertiary referral academic hospitals in Italy, all of which are high-volume centers with extensive experience in the management of NSTIs and other (traumatic and septic) complex surgical emergencies.
Data used for this study are derived from routinely collected clinical information recorded during standard patient care. The dataset includes demographic characteristics, comorbid conditions, physiological parameters, and laboratory test results obtained at hospital admission and during the initial clinical assessment. The selected variables are widely available, rapidly obtainable, and commonly used by clinicians to evaluate patient status at presentation.
The study aims to clarify how combinations of early clinical and laboratory findings are associated with death and other severe in-hospital outcomes.
The study does not seek to influence or modify clinical management but rather to provide prognostic information that may complement clinical judgment.
The analytical approach includes exploratory and confirmatory statistical analyses to assess associations between admission variables and adverse outcomes. Multivariable modeling techniques are used to account for the combined effect of multiple factors and to identify independent predictors of poor outcomes.
The results of the multivariable model will be translated into a graphical risk estimation tool. This tool is intended to provide an intuitive representation of how different admission variables contribute to overall risk.
All data are handled in accordance with applicable ethical standards and data protection regulations. The study uses retrospective data collected during routine care, and appropriate approvals were obtained from institutional authorities at each participating center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with Necrotizing Soft Tissue Infections. | – | Other: No Intervention: Observational CohortAdult patients admitted with a diagnosis of necrotizing soft tissue infection, diagnosed based on clinical findings, imaging when available, and/or intraoperative assessment. |
| Necrotizing Fasciitis | – | Other: No Intervention: Observational CohortPatients with necrotizing infection primarily involving the fascia and surrounding soft tissues, diagnosed based on clinical findings, imaging when available, and/or intraoperative assessment. |
| Fournier's Gangrene | – | Other: No Intervention: Observational CohortPatients with necrotizing infection involving the perineal, genital, or perianal region, consistent with Fournier's gangrene. |
| Necrotizing Soft Tissue Infections of the Neck and Trunk | – | Other: No Intervention: Observational CohortPatients with necrotizing soft tissue infections involving the cervical region or the trunk, including thoracic and abdominal wall locations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo 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. | Other | Fournier's Gangrene, Necrotizing Fasciitis, Necrotizing Soft Tissue Infections of the Neck and Trunk, Patients with Necrotizing Soft Tissue Infections. |
Primary outcome
In-hospital mortality
Time frame: 30 days from hospital admission.
Death from any cause occurring during the index hospitalization for necrotizing soft tissue infection.
1 secondary outcome
Limb amputation (upper or lower extremity)
Time frame: 30 days from hospital admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data sharing is restricted due to patient confidentiality, data protection regulations, and local institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adolfo Pisanu, MD study director
University of Cagliari
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Fascitis and Fournier Gangrene, run by University of Cagliari at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauro Podda, MD, FACS, Professor of Surgery (+39 07051096571, mauro.podda@unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 30 days from hospital admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.