Necrotizing Soft Tissue InfectionNCT04801615
Characteristics of Patients With Necrotizing Soft Tissue Infections
An observational study of Necrotizing Soft Tissue Infection, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
To study the demographic characteristic of patients with necrotizing soft tissue infections. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Soft Tissue Infection
- What is being tested?
- Surgery
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 1 Jun 2025
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients admitted to Aarhus University Hospital with necrotizing soft tissue infections, either diagnosed prior to arriving to the hospital or diagnosed in the hospital.
Who may be able to join
- Patients diagnosed with necrotizing soft tissue infections and treated at Aarhus Universital Hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
per gundtoft, 26195112, pergun@rm.dk
About this study
Official title: Demographic Characteristics, Symptoms, Treatment and Mortality of Patients With Necrotizing Soft Tissue Infections
To study the demographic characteristic of patients with necrotizing soft tissue infections.
Read the detailed description
At Aarhus University Hospital, Denmark, all patients with necrotizing soft tissue infections will be registered in a database in order to be able to describe their symptoms, demographic variables and thier treatment (surgery, time to surgery, antibiotics, intensive care unit, laboratory data etc).
- Conditions
- Necrotizing Soft Tissue Infection
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
All patients in the database undergo surgery due to a suspicion of necrotizing soft tissue infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that dies within 1 year following admission date
The risk of death within 1 year
Measured: 12 months following admission date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Gundtoft, Aarhus University Hospital
- Investigators
- per gundtoft, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801615
- Sponsor's protocol ID
- ICD_20201212
- Status last verified
- Aug 2023
- First submitted
- 23 Dec 2020
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share this with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic Characteristics, Symptoms, Treatment and Mortality of Patients With Necrotizing Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT04801615
- Acronym / sponsor ID
- ICD_20201212
- Conditions
- Necrotizing Soft Tissue Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 17 Mar 2021 (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.
To study the demographic characteristic of patients with necrotizing soft tissue infections.
Detailed description
At Aarhus University Hospital, Denmark, all patients with necrotizing soft tissue infections will be registered in a database in order to be able to describe their symptoms, demographic variables and thier treatment (surgery, time to surgery, antibiotics, intensive care unit, laboratory data etc).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to Aarhus University Hospital with necrotizing soft tissue infections, either diagnosed prior to arriving to the hospital or diagnosed in the hospital.
Key inclusion criteria (1 listed)
- Patients diagnosed with necrotizing soft tissue infections and treated at Aarhus Universital Hospital
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SurgeryAll patients in the database undergo surgery due to a suspicion of necrotizing soft tissue infections | Other | – |
Primary outcome
Percentage of patients that dies within 1 year following admission date
Time frame: 12 months following admission date
The risk of death within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No. We do not plan to share this with other researchers.
Related trials for Necrotizing Soft Tissue Infection
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Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
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Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
Necrotizing Soft Tissue Infection
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Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
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.
per gundtoft principal investigator
Aarhus University Hospital
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 Necrotizing Soft Tissue Infection, run by Aarhus University Hospital at 1 site in Denmark.
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 0 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 7 Aug 2023. 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 Denmark. 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 per gundtoft (26195112, pergun@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that dies within 1 year following admission date (time frame: 12 months following admission date). 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 7 Aug 2023.