NCT05224817

NECROtizing Soft Tissue Infections and Their Scoring System

Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,010 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

Summary

Primary Objective: The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection. Secondary Objectives: To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.

Detailed description

This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.

Conditions

• Necrosis

Interventions

Type	Name	Description
OTHER	Necrotizing soft tissue infections (NSTIs)	There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-12-30
• Completion: 2023-01-30
• First posted: 2022-02-04
• Last updated: 2022-02-04

Locations

1 site across 1 country: United States