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

Study Overview
=================
Brief 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. 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 : 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 To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

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.

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

Conditions
-----------------
Necrotizing Fasciitis, Fournier Gangrene, Necrotizing Soft Tissue Infection

Intervention / Treatment
-----------------
* Other: non interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: Patient deprived of liberty by judicial or administrative decision or patient under guardianship Expressed opposition to project's participation at the project

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: non interventional|Multinational prospective, standard care data collection, non-interventional, study not involving human subjects|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | day 90 | 
| Microbiology | Microorganisms involved in blood cultures and per operative tissue samples (species, antibiogram, resistance and difficult to treat status) | 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 | 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). | 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 | Within 24 hours of hospital admission | 
| Anatomic location | Llimbs upper or lower, abdomino-perineal, neck/head, periarticular/circonferential involvement | Within 24 hours of hospital admission | 
| Body surface area involved | Quantified with the Wallace rule of nine | 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) | Within 24 hours of hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
necrotizing soft tissue infection, Necrotizing Fasciitis, Fournier Gangrene