Benjamin T. Miller
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. Data will be collected in a secure manner using REDCap housed at CCF. The study will consist of 2 arms: treatment with Cytal® Wound Matrix 2-Layer and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, U.S.A.) versus standard of care dressings. Wound debridement procedures will be performed by surgical staff at CCF. A co-investigator trained in the application of Cytal® Wound Matrix and MicroMatrix® will apply these treatments as outlined in section 6.1.2 Administration. This study will be conducted with IRB approval and written informed consent of each participant enrolled. The trial will be registered at ClinicalTrials.gov before the first participant is enrolled.
Necrotizing fasciitis (NF) is a type of soft tissue infection that is characterized by necrosis of the subcutaneous tissues and muscle fascia. Prompt diagnosis and surgical exploration are crucial in the management of these potentially fatal infections.1,2 For most patients, this requires an initial extensive, wide debridement with repeated inspection and debridement every 24-48 hours to remove all necrotic tissue.3 As a result, tissue reconstruction often necessitates flap surgery with autologous, split-thickness skin grafting (STSG) for sufficient coverage. The process during which the wound…
Inclusion Criteria: 1. Adults (≥ 18 years) with a diagnosis of necrotizing fasciitis 2. Wound ≥ 30 cm2 3. The participant is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen. Exclusion Criteria: 1. Burn as etiology of wound 2. Acute osteomyelitis requiring active treatment 3. Known allergy, hypersensitivity, or objection to porcine materials 4. Pregnant participants 5. Lack of English language fluency 6. Participant report of concurrent participation in another clinical trial that would interfere w…
This is the only study to use this intervention in necrotizing soft tissue wounds
This is the only study to use this intervention in necrotizing soft tissue wounds
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