CClinicalTrials.gg
Status unknownNCT05224817Updated Feb 4, 2022

NECROtizing Soft Tissue Infections and Their Scoring System

An observational study in Necrosis, sponsored by Methodist Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-02-04.

Sponsored by Methodist Health System · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,010
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Necrosis
03

In context

Soft Tissue Infections

90 studies on the registry are indexed under Soft Tissue Infections; 11 are open to participants now.

This study's planned enrollment of 1,010 is above the median of 300 across 28 observational studies indexed under Soft Tissue Infections.

Browse Soft Tissue Infections studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
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.

Inclusion criteria

  • All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years old and age > 89 years
  • Pregnancy
  • Prisoners
  • Below ankle diabetic foot infections complicated by peripheral vascular disease
  • Burn wounds
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,010 participants (estimated)
Patient registry
No

Interventions

  • OtherNecrotizing 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.

06

What researchers measure

Primary outcomes

  1. Change in the presence of necrosis

    presence of necrosis-"dishwater" fluid or deliquescent tissues

    Time frame: up to 30 days

  2. Change in the presence of necrosis

    thrombosed vessels or absence of bleeding

    Time frame: up to 30 days

  3. mortality length of time in hospital

    Time frame: 30-90 days

07

Study locations

1 of 1 sites recruiting
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05224817
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Nov 1, 2019
Primary completion
Dec 30, 2022 (estimated)
Completion
Jan 30, 2023 (estimated)
Last update
Feb 4, 2022

Study contacts

Crystee Cooper, DHEd
Contact
ClinicalResearch@mhd.com
214-947-1280
Ashley Haider
Contact
ClinicalResearch@mhd.com
214-947-1280
Michael Truitt, M.D.
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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