Actively Recruiting
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal ae Wound Matrix and MicroMatrix ae
Led by Benjamin T. Miller · Updated on 2026-04-03
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates treatments for necrotizing soft tissue infections, specifically necrotizing fasciitis, a serious infection that destroys soft tissue and muscle layers. The study aims to compare the healing process of wounds treated with two special products, Cytal ae Wound Matrix 2-Layer and MicroMatrix ae, against standard wound care. This trial is a prospective, randomized controlled pilot study conducted at a single center to explore if these products can help wounds heal faster and reduce the time before skin grafting is possible. Participants will be randomly assigned to one of two groups: one receiving Cytal ae Wound Matrix and MicroMatrix ae applied by trained staff, and the other receiving standard wound dressings. All participants will undergo wound debridement performed by surgical staff as part of their care. The treatments will be applied and managed under close supervision at the Cleveland Clinic Foundation. Data collection will be securely managed, and the study is conducted with ethical approval and informed consent. During the study, participants will be monitored for wound healing progress, including the time until the wound bed is ready for skin grafting, assessed up to 12 weeks after randomization. Researchers will also evaluate wound healing quality using photographic tools, track infections and complications, and measure the size and success of skin grafts. Follow-up includes regular assessments to monitor safety and treatment effects throughout the treatment period.
CONDITIONS
Brief Title
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with a diagnosis of necrotizing fasciitis
- Wound size of 30 cm2 or greater
- Ability and willingness to follow the study protocol and attend follow-up visits
You will not qualify if you...
- Wounds caused by burns
- Acute osteomyelitis requiring active treatment
- Known allergy or hypersensitivity to porcine (pig-derived) materials
- Pregnant individuals
- Inability to speak English fluently
- Currently participating in another clinical trial that conflicts with this study
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks or until readiness for skin grafting
Participants receive application of Cytal® Wound Matrix and MicroMatrix® or standard of care dressings on their necrotizing soft tissue infection wounds.
Repeated visits every 24 to 48 hours for wound debridement and treatment application
Duration - Up to 12 weeks from randomization
Participants attend follow-up visits to assess wound healing, monitor for complications, and evaluate readiness for skin grafting.
Multiple follow-up visits during the treatment period
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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