Necrotizing Soft Tissue Infections

NCT ID: NCT07107555

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-03-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Hospital del Mar Research Institute (IMIM)

OTHER

Sponsor Role: collaborator

Hospital del Mar

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: collaborator

European Society for Trauma and Emergency Surgery

OTHER

Sponsor Role: lead

Responsible Party

Ana María González Castillo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary A Bass, MD PhD

Role: STUDY_CHAIR

University of Pennsylvania

Ana Maria González Castillo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Locations

Hospital del Mar

Barcelona, , Spain

Countries

Spain

Other Identifiers

SnapNSTI

Identifier Type: -

Identifier Source: org_study_id