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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Benjamin T. Miller
Study ID
NCT06857708
Status
Recruiting
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Conditions

  • Necrotizing Fascitis
  • Necrotizing Soft Tissue Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cytal® Wound Matrix — DEVICE
    This is the only study to use this intervention in necrotizing soft tissue wounds
  • MicroMatrix® — DEVICE
    This is the only study to use this intervention in necrotizing soft tissue wounds

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional arm
    This arm will receive application of Cytal® Wound Matrix and MicroMatrix®
  • No Intervention: Standard of Care Arm

Primary Outcome Measure

Time to readiness for grafting of the wound bed [ Time Frame: From randomization to readiness for grating, up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Kimberly Woo
[email protected]
2163999672
Benjamin Miller, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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