Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrosis
- Sponsor
- Methodist Health System
- Enrollment
- 1010
- Locations
- 1
- Primary Endpoint
- mortality length of time in hospital
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
mortality length of time in hospital
Time Frame: 30-90 days
Change in the presence of necrosis
Time Frame: up to 30 days
thrombosed vessels or absence of bleeding