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NECROtizing Soft Tissue Infections and Their Scoring System

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05224817
Enrollment
1010
Registered
2022-02-04
Start date
2019-11-01
Completion date
2023-01-30
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrosis

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.

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.

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.

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the presence of necrosisup to 30 dayspresence of necrosis-dishwater fluid or deliquescent tissues
mortality length of time in hospital30-90 days

Countries

United States

Contacts

Primary ContactCrystee Cooper, DHEd
ClinicalResearch@mhd.com214-947-1280
Backup ContactAshley Haider
ClinicalResearch@mhd.com214-947-1280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026