Managing necrotizing soft tissue infections with specialized wound matrices
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
This study is testing if special wound dressings can help people with severe skin infections heal better than regular dressings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06857708 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with necrotizing fasciitis and having a wound size of at least 30 cm².
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.
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 performed: Previous studies using extracellular matrices for wound healing have shown promising results, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.