An observational study in Necrotizing Fasciitis, Fournier Gangrene and Necrotizing Soft Tissue Infection, sponsored by Henri Mondor University Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Henri Mondor University Hospital · Observational
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 :
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.
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's planned enrollment of 1,033 is above the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →Henri Mondor University Hospital is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with surgically-confirmed NSTI
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Multinational prospective, standard care data collection, non-interventional, study not involving human subjects
mortality
Time frame: day 90
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.
Time frame: day 90
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).
Time frame: day 90
Microbiology
Microorganisms involved in blood cultures and per operative tissue samples (species, antibiogram, resistance and "difficult to treat" status)
Time frame: During the first 72 hours of hospital admission
Skin grafting and amputation
Skin grafting and limb amputation performed within three months of hospital admission will be recorded
Time frame: At day 90
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).
Time frame: Within 24 hours of hospital admission
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
Time frame: Within 24 hours of hospital admission
Anatomic location
Llimbs upper or lower, abdomino-perineal, neck/head, periarticular/circonferential involvement
Time frame: Within 24 hours of hospital admission
Body surface area involved
Quantified with the Wallace rule of nine
Time frame: Within 24 hours of hospital admission
Portal of entry of the NSTI
Portal of entry of the NSTI will be recorder (e.g., skin ulcer, trauma, other)
Time frame: Within 24 hours of hospital admission
Plan to share: No
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Henri Mondor University Hospital