NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
| NCT ID | NCT06857708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benjamin T. Miller |
| Condition | Necrotizing Fascitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-03-05 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06857708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Necrotizing Fascitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06857708 currently recruiting?
Yes, NCT06857708 is actively recruiting participants. Visit ClinicalTrials.gov or contact Benjamin T. Miller to inquire about joining.
Where is the NCT06857708 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06857708 clinical trial?
NCT06857708 is sponsored by Benjamin T. Miller. The trial plans to enroll 50 participants.