NECROtizing Soft Tissue Infections and Their Scoring System

Methodist Health System

Status: Unknown

Conditions: Necrosis

Treatments: Other: Necrotizing soft tissue infections (NSTIs)

Study type: Observational

Funder types: Other

Identifiers

NCT05224817

056.GME.2019.D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,010 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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