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

Necrotizing Soft Tissue Infection Clinical Trial

— SKIN-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116956
• Other study ID #: 1-0_30042021
• Status: Recruiting
• Start date: November 8, 2021
• Est. completion date: July 22, 2023

Study information

• Verified date: November 2021
• Source: Henri Mondor University Hospital
• Contact: Nicolas de Prost, MD, PhD
• Phone: +33145178617
• Email: nicolasdeprost[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1033
• Est. completion date: July 22, 2023
• Est. primary completion date: July 22, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Fasciitis
• Fasciitis, Necrotizing
• Fournier Gangrene
• Gangrene
• Infections
• Necrotizing Fasciitis
• Necrotizing Soft Tissue Infection
• Soft Tissue Infections

Intervention

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

Locations

Country	Name	City	State
France	Hopital Henri Mondor	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Henri Mondor University Hospital	European Society of Intensive Care Medicine

Country where clinical trial is conducted

France, 

References & Publications (5)

Madsen MB, Skrede S, Bruun T, Arnell P, Rosén 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. — View Citation

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. Review. — View Citation

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. — View Citation

Stevens DL, Bryant AE. Necrotizing Soft-Tissue Infections. N Engl J Med. 2017 Dec 7;377(23):2253-2265. doi: 10.1056/NEJMra1600673. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		day 90
Secondary	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
Secondary	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
Secondary	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
Secondary	Skin grafting and amputation	Skin grafting and limb amputation performed within three months of hospital admission will be recorded	At day 90
Secondary	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
Secondary	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
Secondary	Anatomic location	Llimbs upper or lower, abdomino-perineal, neck/head, periarticular/circonferential involvement	Within 24 hours of hospital admission
Secondary	Body surface area involved	Quantified with the Wallace rule of nine	Within 24 hours of hospital admission
Secondary	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