NECROtizing Soft Tissue Infections and Their Scoring System

• Conditions: Necrosis

• Registration Number: NCT05224817
• Lead Sponsor: Methodist Health System

Brief 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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-04
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1010

Inclusion Criteria

• All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI

Exclusion Criteria

• Age <18 years old and age > 89 years
• Pregnancy
• Prisoners
• Below ankle diabetic foot infections complicated by peripheral vascular disease
• Burn wounds

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the presence of necrosis	up to 30 days	thrombosed vessels or absence of bleeding
mortality length of time in hospital	30-90 days

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States