Managing necrotizing soft tissue infections with specialized wound matrices
Official title: The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Run by The Cleveland Clinic · NCT06857708 · Data updated 2026-11-12
This study is testing if special wound dressings can help people with severe skin infections heal better than regular dressings.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | March 5, 2025 |
| Main results expected | September 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06857708 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with necrotizing fasciitis and having a wound size of at least 30 cm².
✕Probably not a fit
Patients with burns as the cause of their wounds, acute osteomyelitis requiring treatment, or allergies to porcine materials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a prospective, pilot, parallel group, randomized controlled trial conducted at the Cleveland Clinic Foundation. It compares the effectiveness of Cytal® Wound Matrix and MicroMatrix® against standard care dressings in treating necrotizing fasciitis. Participants will undergo wound debridement by surgical staff, and the specialized treatments will be applied by trained co-investigators. Data will be securely collected using REDCap, and the study will adhere to ethical standards with IRB approval and informed consent.
Why it matters
Potential benefit: If successful, this approach could significantly improve wound healing and reduce the morbidity associated with necrotizing soft tissue infections.
How similar studies have gone: Previous studies using extracellular matrices for wound healing have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Cleveland Clinic
Cleveland, Ohio, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.