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Necrotizing Fasciitis clinical trials

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NCT ID: NCT06073301 Recruiting - Clinical trials for Necrotizing Fasciitis

AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

NF
Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

Necrotizing Fasciitis (NF) is a potentially life-threatening soft tissue infection. This study is comparing acellular fish skin graft (AFS) to standard of care allograft (AHC) in the treatment of NF. The purpose of this study is to compare clinical outcomes and time until autograft take in patients that were treated with AHC or AFS prior to permanent autografting to treat NF.

NCT ID: NCT05116956 Recruiting - Clinical trials for Necrotizing Soft Tissue Infection

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

SKIN-ICU
Start date: November 8, 2021
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT04091672 Completed - Infection Clinical Trials

RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.

NCT ID: NCT02501382 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment

BIONEC-II
Start date: February 2013
Phase:
Study type: Observational

The purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections

NCT ID: NCT02469857 Completed - Clinical trials for Necrotizing Fasciitis

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

ACCUTE
Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

NCT ID: NCT02180906 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Biomarkers in Patients With Flesh-eating Bacterial Infections

BIONEC
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the immune response in patients with necrotizing soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and the following 3 days

NCT ID: NCT02169128 Recruiting - Clinical trials for Necrotizing Fasciitis

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Start date: January 2014
Phase:
Study type: Observational

Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.

NCT ID: NCT02111161 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

INSTINCT
Start date: April 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).

NCT ID: NCT01790698 Completed - Clinical trials for Soft Tissue Infections

Systems Medicine to Study Necrotizing Soft Tissue Infections (NSTIs).

INFECT
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with high morbidity and mortality. The fulminant course of NSTIs demands immediate diagnosis and adequate interventions in order to salvage lives and limbs. However, diagnosis and management are difficult due to heterogeneity in clinical presentation, in co-morbidities and in microbiological aetiology. Thus, there is an urgent need for novel diagnostics and therapeutics in order to improve outcome of NSTIs. A comprehensive knowledge of diagnostic features, causative microbial agent, treatment strategies, and pathogenic mechanisms (host and bacterial disease traits and their underlying interaction network) is required for an improved diagnosis and management of NSTIs. The current proposal is designed to obtain such insights through an integrated systems biology approach in patients and experimental models. The project is based on a prospective NSTI patients cohort including a clinical registry to document clinical data and treatment strategies, combined with an isolate and biobank collection. The samples will be analyzed through advanced bioinformatics and computational modelling work flow to identify and quantify pathogen signatures and underlying networks that contribute to disease outcome. One aim is to translate clinical and systems biology data into development of novel diagnostics.

NCT ID: NCT01731483 Completed - Clinical trials for Infective Endocarditis

Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections

Start date: July 2012
Phase:
Study type: Observational

the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP activation in invasive staphylococcal and streptococcal infections.