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

November 22, 2021 updated by: Nicolas de Prost, Henri Mondor University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1033

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with surgically-confirmed NSTI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: day 90
day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: day 90
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
Time Frame: day 90
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
Time Frame: During the first 72 hours of hospital admission
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
Time Frame: At day 90
Skin grafting and limb amputation performed within three months of hospital admission will be recorded
At day 90
SAPS II score
Time Frame: Within 24 hours of hospital admission
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
Time Frame: Within 24 hours of hospital admission
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
Time Frame: Within 24 hours of hospital admission
Llimbs upper or lower, abdomino-perineal, neck/head, periarticular/circonferential involvement
Within 24 hours of hospital admission
Body surface area involved
Time Frame: Within 24 hours of hospital admission
Quantified with the Wallace rule of nine
Within 24 hours of hospital admission
Portal of entry of the NSTI
Time Frame: Within 24 hours of hospital admission
Portal of entry of the NSTI will be recorder (e.g., skin ulcer, trauma, other)
Within 24 hours of hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henri Mondor University Hospital

Collaborators

European Society of Intensive Care Medicine

Investigators

  • Principal Investigator: Nicolas de Prost, MD, PhD, Service MIR, Hôpital Henri Mondor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Anticipated)

July 22, 2023

Study Completion (Anticipated)

July 22, 2023

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-0_30042021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fournier Gangrene

Clinical Trials on non interventional

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe