Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT05224817

Conditions

Necrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Necrotizing soft tissue infections (NSTIs)

Study Details

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.

Conditions

Necrosis

Study ID

NCT05224817

Start date

Nov 1, 2019

Status verified date

Feb, 2022

Completion date

Jan 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1010 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Change in the presence of necrosis [ Time Frame: up to 30 days ]
  • Change in the presence of necrosis [ Time Frame: up to 30 days ]
  • mortality length of time in hospital [ Time Frame: 30-90 days ]

Central Contacts and Locations

Central contacts

Crystee Cooper, DHEd

214-947-1280ClinicalResearch@mhd.com

Ashley Haider

214-947-1280ClinicalResearch@mhd.com

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Michael Truitt, MD

214-947-2315michaeltruitt@mhd.com

More Information

Sponsor

Methodist Health System

Last update posted

Feb 4, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2022-02-04.