NECROtizing Soft Tissue Infections and Their Scoring System

Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224817
• Other study ID #: 056.GME.2019.D
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2022
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: ClinicalResearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1010
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Soft Tissue Infections

Intervention

Other:
• Necrotizing soft tissue infections (NSTIs)
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.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the presence of necrosis	presence of necrosis-"dishwater" fluid or deliquescent tissues	up to 30 days
Primary	Change in the presence of necrosis	thrombosed vessels or absence of bleeding	up to 30 days
Primary	mortality length of time in hospital		30-90 days