Necrotizing Soft Tissue InfectionSnapNSTINCT07107555
Necrotizing Soft Tissue Infections
An observational study of Necrotizing Soft Tissue Infection and Fournier Gangrene, run by European Society for Trauma and Emergency Surgery at 1 site in Spain.
Trial summary
SnapNSTI is an international, multicenter, time-bound prospective observational cohort study designed to characterize current epidemiology, management patterns, and outcomes of patients with necrotizing soft-tissue infections (NSTI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infection, Fournier Gangrene, Sepsis
- Type of treatment
- Injection or infusion
- How many people
- 480 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 31 Mar 2027
- 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: Adults aged 18 years or older admitted to participating hospitals with a confirmed diagnosis of necrotizing soft-tissue infection (NSTI). The diagnosis must be based on surgical or histopathological evidence of fascial necrosis, or radiologic confirmation (e.g., gas in the fascial plane). Patients will be enrolled consecutively over a 6-month window at each site. The study includes diverse international centers in all over the world.
Who may be able to join
- Age ≥18 years
- Diagnosis of necrotizing soft-tissue infection (NSTI) confirmed by:
- Surgical or histopathological evidence of fascial necrosis
- OR imaging showing gas in the fascial plane
- Admitted to a participating hospital during the enrollment period
Who cannot join
- Non Severe soft-tissue infection
- Patients <18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SnapNSTI: An International Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Necrotizing Soft Tissue Infections
SnapNSTI is an international, multicenter, time-bound prospective observational cohort study designed to characterize current epidemiology, management patterns, and outcomes of patients with necrotizing soft-tissue infections (NSTI). The primary objective is to estimate 90-day all-cause mortality and to evaluate the variability in management across centers. The study will also explore the association between clinical characteristics, treatments, and patient-reported outcomes.
Read the detailed description
Necrotizing soft-tissue infections (NSTIs) are life-threatening surgical emergencies with high mortality despite timely surgical debridement and antibiotic treatment. Wide variability in treatment strategies-ranging from diagnostic imaging to operative timing and adjunctive therapies-contributes to outcome heterogeneity, yet no standardized, high-resolution prospective data exist to guide best practices.
SnapNSTI is a time-bound, multicenter international observational cohort study coordinated by the Center for Emergency Surgery Outcomes Research (CESOR) at the University of Pennsylvania, and led by a consortium of international surgical societies. The study will enroll adult patients with confirmed NSTI over a 6-month window at each participating site within a 12-month period starting in 2026.
The primary outcome is 90-day all-cause mortality. Secondary outcomes include organ support-free days, in-hospital complications, length of stay, and 60-day patient-reported outcomes (PROMs, including the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument). Standardized definitions and real-time REDCap-based data collection will ensure data quality. Analyses will include multivariable regression, propensity score methods, and target trial emulation. Results will inform future interventional research and evidence-based guidelines.
- Conditions
- Necrotizing Soft Tissue Infection, Fournier Gangrene, Sepsis, Surgical Infection, Soft Tissue Infections
- Keywords
- diagnosis, management, microbiology, patient related outcome measures, outcomes, NSTI, Necrotizing Soft Tissue Infection, Fournier Gangrene, Soft Tissue Infection, Severe Skin and Soft Tissue Infection, Debridement, Sepsis, Snapshot Audit
- Medical subject headings
- Fournier Gangrene, Sepsis, Soft Tissue Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Necrotizing Soft Tissue Infection | This is a prospective, multicenter, observational cohort study of adults (≥18 years) with necrotizing soft-tissue infection (NSTI), defined by surgical/histopathological confirmation or imaging evidence of fascial gas. Participants receive standard care; no interventions are mandated. Data collection includes timing and extent of debridement, antimicrobial regimens, and adjunctive therapies (e.g., intravenous immunoglobulin, hyperbaric oxygen, negative pressure wound therapy), as well as critical care support. Primary outcome is 90-day all-cause mortality; secondary outcomes include organ failure-free days, complications, and 90-day patient-reported outcome measures (PROMs) using EQ-5D-5L. Subgroup analyses will examine variations in practice and outcomes (e.g., immunocompromised status, Fournier's gangrene). |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day all-cause mortality
All-cause mortality measured at 90 days from hospital admission in patients with confirmed necrotizing soft-tissue infection (NSTI). Mortality status will be obtained via chart review, clinical follow-up or telephone contact.
Measured: 90 days from admission
Secondary outcomes (5)
Organ failure-free days within first 30 days
Number of days alive and free from mechanical ventilation, vasopressors, or renal replacement therapy within 28 days from admission.
Measured: 30 days from admission
Hospital and ICU length of stay
Number of days from hospital admission to discharge in ICU, including both days. Reported in days, as a continuous variable.
Measured: From admision to ICU to discharge to the ward or death
Number and type of reoperations
Number and type of surgical re-interventions performed after the initial debridement, including amputations, repeat debridement, and drainage procedures.
Measured: From admission to 90 days
Patient-reported quality of life (EQ-5D-5L)
Self-reported health status at 60 days after admission using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. This includes five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a 5-point scale (1 = no problems; 5 = extreme problems). The score varies from 5 to 25 points.
Measured: 60 days from admission
Readmission and return to surgery within 90 days
Incidence and reasons for hospital readmissions or return to operating room within 90 days from index admission.
Measured: 90 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionStudies 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
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Society for Trauma and Emergency Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Hospital del Mar Research Institute (IMIM), Hospital del Mar, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Birmingham
- Responsible party
- Principal investigator, Ana María González Castillo, European Society for Trauma and Emergency Surgery
- Investigators
- Gary A Bass, MD PhD, Study chair, University of PennsylvaniaAna Maria González Castillo, MD PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107555
- Sponsor's protocol ID
- SnapNSTI
- Acronym
- SnapNSTI
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including clinical variables and patient-reported outcomes (PROMs), will be available upon reasonable request and approval by the study Steering Committee.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SnapNSTI: An International Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Necrotizing Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT07107555
- Acronym / sponsor ID
- SnapNSTI / SnapNSTI
- Conditions
- Necrotizing Soft Tissue Infection, Fournier Gangrene, Sepsis, Surgical Infection, Soft Tissue Infections
- Keywords
- diagnosis, management, microbiology, patient related outcome measures, outcomes, NSTI, Necrotizing Soft Tissue Infection, Fournier Gangrene
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- European Society for Trauma and Emergency SurgeryUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Hospital del Mar Research Institute (IMIM), Hospital del Mar, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Birmingham
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
SnapNSTI is an international, multicenter, time-bound prospective observational cohort study designed to characterize current epidemiology, management patterns, and outcomes of patients with necrotizing soft-tissue infections (NSTI). The primary objective is to estimate 90-day all-cause mortality and to evaluate the variability in management across centers. The study will also explore the association between clinical characteristics, treatments, and patient-reported outcomes.
Detailed description
Necrotizing soft-tissue infections (NSTIs) are life-threatening surgical emergencies with high mortality despite timely surgical debridement and antibiotic treatment. Wide variability in treatment strategies-ranging from diagnostic imaging to operative timing and adjunctive therapies-contributes to outcome heterogeneity, yet no standardized, high-resolution prospective data exist to guide best practices.
SnapNSTI is a time-bound, multicenter international observational cohort study coordinated by the Center for Emergency Surgery Outcomes Research (CESOR) at the University of Pennsylvania, and led by a consortium of international surgical societies. The study will enroll adult patients with confirmed NSTI over a 6-month window at each participating site within a 12-month period starting in 2026.
The primary outcome is 90-day all-cause mortality. Secondary outcomes include organ support-free days, in-hospital complications, length of stay, and 60-day patient-reported outcomes (PROMs, including the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument). Standardized definitions and real-time REDCap-based data collection will ensure data quality. Analyses will include multivariable regression, propensity score methods, and target trial emulation. Results will inform future interventional research and evidence-based guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Necrotizing Soft Tissue Infection | – | –This is a prospective, multicenter, observational cohort study of adults (≥18 years) with necrotizing soft-tissue infection (NSTI), defined by surgical/histopathological confirmation or imaging evidence of fascial gas. Participants receive standard care; no interventions are mandated. Data collection includes timing and extent of debridement, antimicrobial regimens, and adjunctive therapies (e.g., intravenous immunoglobulin, hyperbaric oxygen, negative pressure wound therapy), as well as critical care support. Primary outcome is 90-day all-cause mortality; secondary outcomes include organ failure-free days, complications, and 90-day patient-reported outcome measures (PROMs) using EQ-5D-5L. Subgroup analyses will examine variations in practice and outcomes (e.g., immunocompromised status, Fournier's gangrene). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older admitted to participating hospitals with a confirmed diagnosis of necrotizing soft-tissue infection (NSTI). The diagnosis must be based on surgical or histopathological evidence of fascial necrosis, or radiologic confirmation (e.g., gas in the fascial plane). Patients will be enrolled consecutively over a 6-month window at each site. The study includes diverse international centers in all over the world.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosis of necrotizing soft-tissue infection (NSTI) confirmed by:
- Admitted to a participating hospital during the enrollment period
Key exclusion criteria (2 listed)
- Non Severe soft-tissue infection
- Patients <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day all-cause mortality
Time frame: 90 days from admission
All-cause mortality measured at 90 days from hospital admission in patients with confirmed necrotizing soft-tissue infection (NSTI). Mortality status will be obtained via chart review, clinical follow-up or telephone contact.
5 secondary outcomes
Organ failure-free days within first 30 days
Time frame: 30 days from admission
Hospital and ICU length of stay
Time frame: From admision to ICU to discharge to the ward or death
Number and type of reoperations
Time frame: From admission to 90 days
Patient-reported quality of life (EQ-5D-5L)
Time frame: 60 days from admission
Readmission and return to surgery within 90 days
Time frame: 90 days from 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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including clinical variables and patient-reported outcomes (PROMs), will be available upon reasonable request and approval by the study Steering Committee.
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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.
Gary A Bass, MD PhD study chair
University of Pennsylvania
Ana Maria González Castillo, MD PhD principal investigator
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Soft Tissue Infection and Fournier Gangrene, run by European Society for Trauma and Emergency Surgery at 1 site in Spain.
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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day all-cause mortality (time frame: 90 days from 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 6 Aug 2025.