Clinical Trials Logo

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05116956
Study type Observational [Patient Registry]
Source Henri Mondor University Hospital
Contact Nicolas de Prost, MD, PhD
Phone +33145178617
Email nicolasdeprost@gmail.com
Status Recruiting
Phase
Start date November 8, 2021
Completion date July 22, 2023

See also
  Status Clinical Trial Phase
Terminated NCT05157360 - HAT for the Treatment of Sepsis Associated With NASTI Phase 1/Phase 2
Recruiting NCT04801615 - Characteristics of Patients With Necrotizing Soft Tissue Infections
Withdrawn NCT02314468 - Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation N/A
Terminated NCT03403751 - Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury Phase 3
Terminated NCT05032625 - To Evaluate the Outcomes After Surgery for Necrotizing Soft Tissue Infections
Recruiting NCT05243966 - Myriad™ Augmented Soft Tissue Reconstruction Registry
Active, not recruiting NCT06126263 - Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections
Completed NCT02180906 - Biomarkers in Patients With Flesh-eating Bacterial Infections N/A
Completed NCT02501382 - Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment
Completed NCT03147352 - Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study
Recruiting NCT06002607 - Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
Completed NCT02111161 - Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial Phase 2
Recruiting NCT03482245 - The Role of Circadian Clock Proteins in Innate and Adaptive Immunity N/A