NECROtizing Soft Tissue Infections and Their Scoring System

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

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.

Study Overview

• Status: Recruiting
• Conditions: Necrosis
• Intervention / Treatment: Other: Necrotizing soft tissue infections (NSTIs)

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 Type: Observational
• Enrollment (Anticipated): 1010

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Michael Truitt, MD; Phone Number: 214-947-2315; Email: michaeltruitt@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Necrosis; Soft Tissue Infections
• Other Study ID Numbers: 056.GME.2019.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No