RecruitingNot ApplicableNCT06857708

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


Sponsor

Benjamin T. Miller

Enrollment

50 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adults (≥ 18 years) with a diagnosis of necrotizing fasciitis
  • Wound ≥ 30 cm2
  • 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 Criteria7

  • Burn as etiology of wound
  • Acute osteomyelitis requiring active treatment
  • Known allergy, hypersensitivity, or objection to porcine materials
  • Pregnant participants
  • Lack of English language fluency
  • Participant report of concurrent participation in another clinical trial that would interfere with this study
  • Inability to consent

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Interventions

DEVICECytal® Wound Matrix

This is the only study to use this intervention in necrotizing soft tissue wounds

DEVICEMicroMatrix®

This is the only study to use this intervention in necrotizing soft tissue wounds


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT06857708


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