The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Recruiting now · Not applicable
Conditions studied: Necrotizing Fascitis, Necrotizing Soft Tissue Infection
In brief
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 facts
- Study ID
- NCT06857708
- Run by
- Benjamin T. Miller
- People needed
- 50
- Starts
- 2025-03-05
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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