NECROtizing Soft Tissue Infections and Their Scoring System
Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score
1 other identifier
observational
1,010
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedFebruary 4, 2022
February 1, 2022
3.2 years
November 4, 2019
February 3, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Change in the presence of necrosis
presence of necrosis-"dishwater" fluid or deliquescent tissues
up to 30 days
Change in the presence of necrosis
thrombosed vessels or absence of bleeding
up to 30 days
mortality length of time in hospital
30-90 days
Interventions
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.
Eligibility Criteria
study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.
You may qualify if:
- All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI
You may not qualify if:
- Age \<18 years old and age \> 89 years
- Pregnancy
- Prisoners
- Below ankle diabetic foot infections complicated by peripheral vascular disease
- Burn wounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Truitt, M.D.
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
February 4, 2022
Study Start
November 1, 2019
Primary Completion
December 30, 2022
Study Completion
January 30, 2023
Last Updated
February 4, 2022
Record last verified: 2022-02