NECROtizing Soft Tissue Infections and Their Scoring System

NCT ID: NCT05224817

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1010 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2023-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Necrosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Truitt, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Crystee Cooper, DHEd

Role: CONTACT

214-947-1280

Ashley Haider

Role: CONTACT

214-947-1280

Facility Contacts

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Michael Truitt, MD

Role: primary

214-947-2315

Other Identifiers

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056.GME.2019.D

Identifier Type: -

Identifier Source: org_study_id

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