Clinical trials: Necrotising Soft Tissue Infections
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
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
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 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
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
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 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
Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the SURFAST Care Pathway.
Necrotising soft-tissue infections (NSTIs) are rare and life-threatening skin and soft tissue infections requiring urgent combined medical and surgical management in specialist centres.
- Trial name
- SURFAST (NCT07417982)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
Pressure Injury, Venous Ulcer
MicroMatrix® Flex in Tunneling Wounds
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
- Conditions
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers
- Trial name
- NCT06629506
- Testing
- MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Necrotizing Soft Tissue Infection, Necrotizing Fascitis
Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study
The investigators will analyze biomarkers related to the prognosis and treatment of necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial and immune system biomarkers can function as markers…
- Conditions
- Necrotizing Soft Tissue Infection, Necrotizing Fascitis, Gas Gangrene, Fournier Gangrene
- Trial name
- ProTreat (NCT03147352)
- Testing
- Hyperbaric oxygen therapy
- Where
- Denmark
- Volunteers
- 260 people
- Sponsor
- Ole Hyldegaard