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Necrotizing FasciitisSKIN-ICUNCT05116956

SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study

An observational study of Necrotizing Fasciitis and Fournier Gangrene, run by Henri Mondor University Hospital at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
non interventional
How many people
1,033 participants
Where
1 siteFrance
Study dates
8 Nov 2021to 22 Jul 2023
How long will I take part?
3 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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patient with surgically-confirmed NSTI

Who may be able to join

  • Age > 18 years
  • Patient with surgically-confirmed NSTI (i.e., macroscopic appearance of tissue during surgery revealing swollen, dull gray tissues with a thin, brownish exudate with or without necrosis)

Who cannot join

  • Patient deprived of liberty by judicial or administrative decision or patient under guardianship
  • Expressed opposition to project's participation at the project

Trial locations and contacts

1 site in 1 country.

Nicolas de Prost, MD, PhD contact

+33145178617

nicolasdeprost@gmail.com

Narimane Zeghbib contact

+33149814536

narimane.zeghbib@aphp.fr

France1 site, 1 recruiting

  • Hopital Henri Mondor

    Créteil, 94000

    Nicolas De Prost, Pr, nicolas.de-prost@aphp.fr

    Recruiting

Other trials in France

About this study

Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not.

The objectives of the study are :

  1. To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes
  2. To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life
Read the detailed description

Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. The mortality of NSTIs is high, ranging from 9% in non-selected patients to up to 30% in the most severe forms requiring intensive care unit (ICU) admission .

With an incidence of 4/100 000 persons per year, initial misdiagnosis is frequent, with no reliable diagnostic test available, frequently leading to a delayed surgical debridement of infected tissues, one of the main modifiable prognostic factors. According to international recommendations, any cutaneous infection associated with the failure of one or more organs or showing a dramatic deterioration must include the diagnosis of NSTI for consideration, even if there is no local sign of the condition being severe. The diagnosis is confirmed by identifying during surgery deficient tissue, sometimes necrotic, which comes away easily in the fingers and by the presence of the typical, foul-smelling "dishwasher" exudate.

The early management of NSTIs is challenging and requires a coordinated and multidisciplinary approach. Treatment of NSTIs consists of early broad-spectrum antimicrobial therapy together with emergency and aggressive surgical debridement including excision of all necrotic and infected tissues. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies.The few randomized therapeutic trials testing interventions in this setting have been disappointing, in part because of the difficulty to identify subgroups for individualized treatments. A large international study aimed at collecting granular data on the clinical presentation, microbiology, management and outcomes of patients with NSTI admitted in the ICU and involving a large number of centers and countries is thus desirable to improve our knowledge on this devastating condition.

The "SKin and soft tissue INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients with NSTI admitted or not to the ICU/intermediate care unit and aim at addressing the following points: 1) Hospital (i.e., ICU and hospital mortality) and medium-term outcomes (three- and six-month survival, functional outcomes and health-related quality of life scores, HR-QoL); and 2) Clinical presentation and microbiological epidemiology of NSTI.

Being tested
non interventional
Keywords
necrotizing soft tissue infection, Necrotizing Fasciitis, Fournier Gangrene
Medical subject headings
Fasciitis, Necrotizing, Fournier Gangrene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non interventionalOther

    Multinational prospective, standard care data collection, non-interventional, study not involving human subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    Measured: day 90

Secondary outcomes (9)

  1. Functional outcome

    Activity of daily living (ADL, 6 questions on selfcare, household, employment, shopping, travel, and communication, each rated 0 (best performance), 1 or 2 (worst performance). An ADL score of 12 indicates a high level of dependence.

    Measured: day 90

  2. Health-related quality of life outcome

    EuroQol five-dimensional descriptive system (EQ-5D-5L score). It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 3 response categories corresponding to no problems, some problems, and extreme problems. The instrument is designed for self-completion, and respondents also rate their overall health on the day of the interview on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS).

    Measured: day 90

  3. Microbiology

    Microorganisms involved in blood cultures and per operative tissue samples (species, antibiogram, resistance and "difficult to treat" status)

    Measured: During the first 72 hours of hospital admission

  4. Skin grafting and amputation

    Skin grafting and limb amputation performed within three months of hospital admission will be recorded

    Measured: At day 90

  5. SAPS II score

    The Simplified Acute Physiology Score II (SAPS II) is a severity of disease score, which is associated with the probability of death at intensive care unit admission (the greater the value of the SAPS II, the greater the odd of death increases).

    Measured: Within 24 hours of hospital admission

  6. SOFA score

    The Sequential Organ Failure Assessment score is a severity of illness score used in sepsis.the greater the value of the SOFA, the greater the odd of death increases

    Measured: Within 24 hours of hospital admission

  7. Anatomic location

    Llimbs upper or lower, abdomino-perineal, neck/head, periarticular/circonferential involvement

    Measured: Within 24 hours of hospital admission

  8. Body surface area involved

    Quantified with the Wallace rule of nine

    Measured: Within 24 hours of hospital admission

  9. Portal of entry of the NSTI

    Portal of entry of the NSTI will be recorder (e.g., skin ulcer, trauma, other)

    Measured: Within 24 hours of hospital admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study start8 Nov 2021
  3. Primary completion22 Jul 2023 (estimated)
  4. Study completion22 Jul 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,033 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05116956
Sponsor's protocol ID
1-0_30042021
Acronym
SKIN-ICU
Status last verified
Nov 2021
First submitted
15 Oct 2021
Last updated
23 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stevens DL, Bryant AE. Necrotizing Soft-Tissue Infections. N Engl J Med. 2017 Dec 7;377(23):2253-2265. doi: 10.1056/NEJMra1600673. No abstract available.

    PubMed 29211672

  • Urbina T, Canoui-Poitrine F, Hua C, Layese R, Alves A, Ouedraogo R, Bosc R, Sbidian E, Chosidow O, Dessap AM, de Prost N; Henri Mondor Hospital Necrotizing Fasciitis Group. Long-term quality of life in necrotizing soft-tissue infection survivors: a monocentric prospective cohort study. Ann Intensive Care. 2021 Jul 2;11(1):102. doi: 10.1186/s13613-021-00891-9.

    PubMed 34213694

  • Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014 Jul 15;59(2):147-59. doi: 10.1093/cid/ciu296. Epub 2014 Jun 18.

    PubMed 24947530

  • Peetermans M, de Prost N, Eckmann C, Norrby-Teglund A, Skrede S, De Waele JJ. Necrotizing skin and soft-tissue infections in the intensive care unit. Clin Microbiol Infect. 2020 Jan;26(1):8-17. doi: 10.1016/j.cmi.2019.06.031. Epub 2019 Jul 5.

    PubMed 31284035

  • Madsen MB, Skrede S, Bruun T, Arnell P, Rosen A, Nekludov M, Karlsson Y, Bergey F, Saccenti E, Martins Dos Santos VAP, Perner A, Norrby-Teglund A, Hyldegaard O. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT): protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2018 Feb;62(2):272-279. doi: 10.1111/aas.13024. Epub 2017 Oct 29.

    PubMed 29082520

Questions about this trial

What is this clinical trial studying?

An observational study of Necrotizing Fasciitis and Fournier Gangrene, run by Henri Mondor University Hospital at 1 site in France.

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 2 inclusion and 2 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 23 Nov 2021. 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 France. 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 Nicolas de Prost, MD, PhD (+33145178617, nicolasdeprost@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05116956, which also lists 5 linked publications.

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 23 Nov 2021.

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