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Enrolling by Invitation

NCT Number: NCT07107555

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.

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Key information

Conditions

Necrotizing Soft Tissue Infection Bacterial Infections Bacterial Infections and Mycoses Disease Fournier Gangrene Genital Diseases Genital Diseases, Male Infections Inflammation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Soft Tissue Infections Surgical Infection Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Non Severe soft-tissue infection
  • Patients <18 years old

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Organ failure-free days within first 30 days

    Time frame: 30 days from admission

    Number of days alive and free from mechanical ventilation, vasopressors, or renal replacement therapy within 28 days from admission.

  2. Hospital and ICU length of stay

    Time frame: From admision to ICU to discharge to the ward or death

    Number of days from hospital admission to discharge in ICU, including both days. Reported in days, as a continuous variable.

  3. Number and type of reoperations

    Time frame: From admission to 90 days

    Number and type of surgical re-interventions performed after the initial debridement, including amputations, repeat debridement, and drainage procedures.

  4. Patient-reported quality of life (EQ-5D-5L)

    Time frame: 60 days from admission

    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.

  5. Readmission and return to surgery within 90 days

    Time frame: 90 days from admission

    Incidence and reasons for hospital readmissions or return to operating room within 90 days from index admission.

Sponsors and collaborators

Lead sponsor

European Society for Trauma and Emergency Surgery

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Hospital del Mar
  • Hospital del Mar Research Institute (IMIM)
  • University of Birmingham
  • University of Pennsylvania

Registry information

Official study title

SnapNSTI: An International Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Necrotizing Soft Tissue Infections

Acronym: SnapNSTI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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