Necrotizing Soft Tissue Infections

NCT07107555 | Enrolling By Invitation DMC

• 1 other identifier: SnapNSTI
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days from admission

Secondary Outcomes (5)

• Organ failure-free days within first 30 days

  30 days from admission

• Hospital and ICU length of stay

  From admision to ICU to discharge to the ward or death

• Number and type of reoperations

  From admission to 90 days

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

  60 days from admission

• Readmission and return to surgery within 90 days

  90 days from admission

Study Arms (1)

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).

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

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Society for Trauma and Emergency Surgery: lead
• University of Pennsylvania: collaborator
• Hospital del Mar Research Institute (IMIM): collaborator
• Hospital del Mar: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Fournier Gangrene; Sepsis; Soft Tissue Infections; Disease

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary A Bass, MD PhD

  University of Pennsylvania

  STUDY CHAIR

• Ana Maria González Castillo, MD PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication of primary results, and for a period of 5 years.
• Access Criteria: Researchers must submit a methodologically sound proposal to the Steering Committee. Approved proposals will require a data use agreement to ensure appropriate use and protection of data.

Locations

ES (1)