Clinical trials: Necrotizing Soft Tissue Infection
Necrotizing Fascitis
Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections
The goal of this clinical trial is to learn if hyperbaric oxygen is beneficial in treating necrotizing infections and decreasing rates of morbidity and mortality. This study therefore has two aims: 1.
- Trial name
- NCT07170020
- Testing
- Hyperbaric Oxygen Therapy
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Corewell Health West
Necrotizing Soft Tissue Infection, Necrotizing Fasciitis
Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial
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…
- Conditions
- Necrotizing Soft Tissue Infection, Necrotizing Fasciitis, Gas Gangrene, Fournier Gangrene
- Trial name
- INSTINCT (NCT02111161)
- Testing
- IVIG (Privigen), Saline 0.9%
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Anders Perner
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
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.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Necrotizing Soft Tissue Infection, Necrotizing Fasciitis
Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment
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
- Conditions
- Necrotizing Soft Tissue Infection, Necrotizing Fasciitis, Gas Gangrene, Fournier Gangrene
- Trial name
- BIONEC-II (NCT02501382)
- Where
- Denmark
- Volunteers
- 65 people
- Sponsor
- Ole Hyldegaard
Necrotizing Soft Tissue Infection, Necrotizing Fasciitis
Biomarkers in Patients With Flesh-eating Bacterial Infections
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…
- Conditions
- Necrotizing Soft Tissue Infection, Necrotizing Fasciitis, Gas Gangrene, Fournier Gangrene
- Trial name
- BIONEC (NCT02180906)
- Where
- Denmark
- Volunteers
- 169 people
- Sponsor
- Ole Hyldegaard
Necrotizing Soft Tissue Infections
Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of…
- Trial name
- NCT01417780
- Testing
- AB103
- Where
- 7 sites in United States
- Volunteers
- 43 people
- Sponsor
- Atox Bio Ltd
Necrotizing Soft Tissue Infection, Fournier Gangrene
Necrotizing Soft Tissue Infections
SnapNSTI is an international, multicenter, time-bound prospective observational cohort study designed to characterize current epidemiology, management patterns, and outcomes of patients with necrotizing soft-tissue infections…
- Conditions
- Necrotizing Soft Tissue Infection, Fournier Gangrene, Sepsis, Surgical Infection
- Trial name
- SnapNSTI (NCT07107555)
- Where
- Spain
- Volunteers
- 480 people
- Sponsor
- European Society for Trauma and Emergency Surgery
Necrotizing Fasciitis
Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles.
- Trial name
- NCT02169128
- Where
- 3 sites in Denmark, Sweden
- Volunteers
- 30 people
- Sponsor
- Göteborg University
Necrotizing Soft Tissue Infections
RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections
Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections Tissue biopsies will…
- Trial name
- NSTI (NCT02025816)
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Texas Tech University Health Sciences Center
Necrotizing Soft Tissue Infection
To Evaluate the Outcomes After Surgery for Necrotizing Soft Tissue Infections
There is significant mortality associated with necrotizing soft tissue infections, it is imperative to decrease mortality and complications associated with this disease is determined.
- Trial name
- NCT05032625
- Testing
- Surgery
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- New York Medical College
Necrotizing Fascitis
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Necrotizing soft-tissue infections (NSTIs, a.k.a. "necrotizing fasciitis" or "flesh-eating bacteria") are aggressive infections that can progress rapidly from mild symptoms to sepsis, multi-organ failure, and death.
- Trial name
- NCT06877793
- Testing
- Administration of indocyanine green (ICG) and fluorescence imaging
- Where
- 8 sites in United States
- Volunteers
- 420 people
- Sponsor
- Eric R. Henderson
Necrotizing Soft Tissue Infections, Necrotizing Fasciitis
Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
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.
- Conditions
- Necrotizing Soft Tissue Infections, Necrotizing Fasciitis, Fournier's Gangrene
- Trial name
- ACCUTE (NCT02469857)
- Testing
- AB103 0.5 mg/kg, NaCl 0.9%
- Where
- 71 sites in United States, France
- Volunteers
- 290 people
- Sponsor
- Atox Bio Ltd
Necrotizing Soft Tissue Infection, Sepsis
HAT for the Treatment of Sepsis Associated With NASTI
Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis.
- Trial name
- NCT05157360
- Testing
- HAT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ascension Health
Air or Gas Embolism, Carbon Monoxide Poisoning
Hyperbaric Oxygen Therapy Registry
The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world patient outcome and side effect information from electronic health records submitted to a specialty specific hyperbaric registry as part of…
- Conditions
- Air or Gas Embolism, Carbon Monoxide Poisoning, Clostridial Myositis and Myonecrosis (Gas Gangrene), Crush Injury, Compartment Syndrome & Other Acute Traumatic Ischemias
- Trial name
- HBOTR (NCT02483650)
- Volunteers
- 5,000 people
- Sponsor
- U.S. Wound Registry
Necrotizing Soft Tissue Infection
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades.
- Trial name
- HOT-NSTI (NCT07489274)
- Testing
- Hyperbaric oxygen treatment, Standard of Care (Investigator Choice)
- Where
- 2 sites in Belgium, Norway
- Volunteers
- 1,480 people
- Sponsor
- Ole Hyldegaard
Necrotizing Fascitis, Fournier Gangrene
FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).
Necrotizing soft tissue infections (NSTIs) are rare but potentially life-threatening infections involving the skin and underlying tissues such as fat, fascia, and sometimes muscle.
- Conditions
- Necrotizing Fascitis, Fournier Gangrene, Fournier's Gangrene, Soft Tissue Infections
- Trial name
- FATAL-NSTI (NCT07359651)
- Testing
- No Intervention: Observational Cohort
- Where
- 4 sites in Italy
- Volunteers
- 300 people
- Sponsor
- University of Cagliari
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
Necrosis
NECROtizing Soft Tissue Infections and Their Scoring System
Primary Objective: The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue…
- Trial name
- NCT05224817
- Testing
- Necrotizing soft tissue infections (NSTIs)
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Methodist Health System
Acute Kidney Injury, Peritonitis
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Trial name
- NCT03403751
- Testing
- Reltecimod 0.5 mg/kg
- Where
- 56 sites in United States, France
- Volunteers
- 58 people
- Sponsor
- Atox Bio Ltd
Necrotizing Fascitis, Necrotizing Soft Tissue Infection
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
This is a prospective, pilot, parallel group, randomized controlled trial with 1:1 allocation. This will be a single center study coordinated at the Cleveland Clinic Foundation (CCF) Main Campus in Cleveland, Ohio.
- Trial name
- NCT06857708
- Testing
- Cytal® Wound Matrix, MicroMatrix®
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Benjamin T. Miller