5 completed, 5 recruiting, 3 terminated, 3 unknown. 4 Not applicable, 2 Phase 2, 1 Phase 1, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 4 | Recruiting 2, Completed 1, Withdrawn 1 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
| Phase 1 | 1 | Terminated 1 |
| Phase 3 | 1 | Terminated 1 |
| Phase 4 | 1 | Recruiting 1 |
Follow Necrotizing Soft Tissue Infection: new trials by email Literature Review of Necrotizing Soft Tissue Infection trials Research Report on Necrotizing Soft Tissue Infection
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Urinary Bladder Matrix (UBM) Registry Urinary Bladder Matrix (UBM) Products - Tissue Repair, Soft Tissue Reconstruction | Not yet recruiting | Integra LifeSciences Corporation | 300 | 2026-08-31 | 2026-09-04 | |
| Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial). Hyperbaric oxygen treatment, Standard of Care (Investigator Choice) - Necrotizing Soft Tissue Infection | Phase 4 | Recruiting | Ole Hyldegaard | 1480 | 2026-04-04 | 2026-09-04 |
| Necrotizing Soft Tissue Infections Necrotizing Soft Tissue Infection, Fournier Gangrene | Enrolling by invitation | European Society for Trauma and Emergency Surgery | 480 | 2026-01-01 | 2025-08-06 | |
| The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® Cytal® Wound Matrix, MicroMatrix® - Necrotizing Fascitis, Necrotizing Soft Tissue Infection | Not applicable | Recruiting | Benjamin T. Miller | 50 | 2025-03-05 | 2026-10-21 |
| MicroMatrix® Flex in Tunneling Wounds MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer - Pressure Injury, Venous Ulcer | Not applicable | Completed | Integra LifeSciences Corporation | 25 | 2024-12-12 | 2026-03-05 |
| The Role of Circadian Clock Proteins in Innate and Adaptive Immunity Blue Light - Pneumonia, Necrotizing Soft Tissue Infection | Not applicable | Recruiting | Washington University School of Medicine | 144 | 2024-10-29 | 2026-02-11 |
| Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections Antibiotic duration (short course), Antibiotic duration (extended course) - Necrotizing Soft Tissue Infection | Recruiting | University of California, Irvine | 50 | 2023-12-28 | 2026-02-10 | |
| Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections Linezolid, Clindamycin - Streptococcal Sepsis, Invasive Group A Beta-Haemolytic Streptococcal Disease | Unknown | National Institutes of Health Clinical Center (CC) | 1000 | 2023-01-01 | 2023-11-13 | |
| Myriad™ Augmented Soft Tissue Reconstruction Registry Myriad Matrix™ and Myriad Morcells™ - Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection | Recruiting | Aroa Biosurgery Limited | 800 | 2022-01-10 | 2026-07-15 | |
| SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study non interventional - Necrotizing Fasciitis, Fournier Gangrene | Unknown | Henri Mondor University Hospital | 1033 | 2021-11-08 | 2021-11-23 | |
| HAT for the Treatment of Sepsis Associated With NASTI HAT, Placebo - Necrotizing Soft Tissue Infection, Sepsis | Phase 1 / Phase 2 | Terminated | Ascension Health | 10 | 2021-09-10 | 2024-07-24 |
| Characteristics of Patients With Necrotizing Soft Tissue Infections Surgery - Necrotizing Soft Tissue Infection | Unknown | Aarhus University Hospital | 30 | 2020-09-01 | 2023-08-07 | |
| To Evaluate the Outcomes After Surgery for Necrotizing Soft Tissue Infections Surgery - Necrotizing Soft Tissue Infection | Terminated | New York Medical College | 13 | 2019-07-01 | 2021-09-02 | |
| Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury Reltecimod 0.5 mg/kg, Placebo - Acute Kidney Injury, Peritonitis | Phase 3 | Terminated | Atox Bio Ltd | 58 | 2018-05-24 | 2021-10-12 |
| Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial IVIG (Privigen), Saline 0.9% - Necrotizing Soft Tissue Infection, Necrotizing Fasciitis | Phase 2 | Completed | Anders Perner | 100 | 2014-04-01 | 2016-09-30 |
| Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation Negative pressure wound therapy, Glycerol Preserved Allografts (GPA) - Necrotizing Soft Tissue Infection | Not applicable | Withdrawn | University Hospital, Ghent | 2013-10-01 | 2023-02-10 | |
| Biomarkers in Patients With Flesh-eating Bacterial Infections Necrotizing Soft Tissue Infection, Necrotizing Fasciitis | Completed | Ole Hyldegaard | 169 | 2013-02-01 | 2016-02-17 | |
| Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study Hyperbaric oxygen therapy - Necrotizing Soft Tissue Infection, Necrotizing Fascitis | Completed | Ole Hyldegaard | 260 | 2013-02-01 | 2019-06-24 | |
| Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment Necrotizing Soft Tissue Infection, Necrotizing Fasciitis | Completed | Ole Hyldegaard | 65 | 2013-02-01 | 2019-06-24 |
Fournier Gangrene (7) · Fasciitis, Necrotizing (6) · Sepsis (5) · Soft Tissue Infections (5) · Gas Gangrene (4) · Bacterial Infections (3) · Disease (3) · Fasciitis (3) · Pressure Ulcer (3) · Gangrene (2) · Hidradenitis Suppurativa (2) · Infections (2) · Intraabdominal Infections (2) · Necrosis (2) · Pilonidal Sinus (2)
Infections (11) · Bacterial Infections and Mycoses (9) · Male Urogenital Diseases (8) · Pathological Conditions, Signs and Symptoms (8) · Urogenital Diseases (8) · Genital Diseases (7) · Genital Diseases, Male (7) · Pathologic Processes (7) · Bacterial Infections (6) · Musculoskeletal Diseases (6) · Inflammation (5) · Skin Diseases (5) · Skin and Connective Tissue Diseases (5) · Systemic Inflammatory Response Syndrome (5) · Clostridium Infections (4)
Sodium Chloride (3) · Surgical Procedures, Operative (2) · AB103 (1) · Ascorbic Acid (1) · Blue Light (1) · Clindamycin (1) · Hydrocortisone (1) · Hyperbaric Oxygenation (1) · Immunoglobulin G (1) · Immunoglobulins, Intravenous (1) · Linezolid (1) · Negative-Pressure Wound Therapy (1) · Saline Solution (1) · Standard of Care (1) · Thiamine (1)
Ole Hyldegaard (4) · Integra LifeSciences Corporation (2) · Aarhus University Hospital (1) · Anders Perner (1) · Aroa Biosurgery Limited (1) · Ascension Health (1) · Atox Bio Ltd (1) · Benjamin T. Miller (1) · European Society for Trauma and Emergency Surgery (1) · Henri Mondor University Hospital (1) · National Institutes of Health Clinical Center (CC) (1) · New York Medical College (1) · University Hospital, Ghent (1) · University of California, Irvine (1) · Washington University School of Medicine (1)
United States (9) · Denmark (5) · Belgium (2) · France (2) · Norway (1) · Spain (1)
Ole Hyldegaard, MD, PhD (3) · Marco Bo Hansen, MD (2) · Ahmed Babiker (1) · Anders Perner, Professor (1) · Areg Grigorian, MD (1) · Azra Bihorac, MD (1) · Claire Witherel, Ph.D. (1) · Gary A Bass, MD PhD (1) · Matthew R Rosengart, MD MPH (1) · Nicolas de Prost, MD, PhD (1) · Peter V Polzik, MD (1) · Rifat Latifi, MD (1) · Stan Monstrey, MD, PhD (1) · Thomas Resch, M.D. (1)
PMID 25967993, PMID 26880104, PMID 27399982, PMID 28421246, PMID 28982834, PMID 31916575, PMID 32082310, PMID 42087918, PMID 42690295
2025 (1), R01GM145674 (1)