NecrosisNCT05224817
NECROtizing Soft Tissue Infections and Their Scoring System
An observational study of Necrosis, run by Methodist Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Necrosis
- What is being tested?
- Necrotizing soft tissue infections (NSTIs)
- How many people
- 1,010 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
Study population: study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.
Who may be able to join
- All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI
Who cannot join
- Age <18 years old and age > 89 years
- Pregnancy
- Prisoners
- Below ankle diabetic foot infections complicated by peripheral vascular disease
- Burn wounds
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Michael Truitt, MD, 214-947-2315, michaeltruitt@mhd.com
About this study
Official title: Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score
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.
- Conditions
- Necrosis
- Being tested
- Necrotizing soft tissue infections (NSTIs)
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necrotizing soft tissue infections (NSTIs)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the presence of necrosis
presence of necrosis-"dishwater" fluid or deliquescent tissues
Measured: up to 30 days
Change in the presence of necrosis
thrombosed vessels or absence of bleeding
Measured: up to 30 days
mortality length of time in hospital
Measured: 30-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Nov 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Truitt, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224817
- Sponsor's protocol ID
- 056.GME.2019.D
- Status last verified
- Feb 2022
- First submitted
- 4 Nov 2019
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score
- ClinicalTrials.gov ID
- NCT05224817
- Acronym / sponsor ID
- 056.GME.2019.D
- Conditions
- Necrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.
Key inclusion criteria (1 listed)
- All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI
Key exclusion criteria (5 listed)
- Age <18 years old and age > 89 years
- Pregnancy
- Prisoners
- Below ankle diabetic foot infections complicated by peripheral vascular disease
- Burn wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Change in the presence of necrosis
Time frame: up to 30 days
presence of necrosis-"dishwater" fluid or deliquescent tissues
Change in the presence of necrosis
Time frame: up to 30 days
thrombosed vessels or absence of bleeding
mortality length of time in hospital
Time frame: 30-90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Truitt, M.D. principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrosis, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the presence of necrosis (time frame: up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.