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The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®

RecruitingNAAges 18 Years - anyAllBenjamin T. Miller
NCT06857708 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 with this study 7. Inability to consent
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What it tests

  • Cytal® Wound Matrix
  • MicroMatrix®
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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