About this trial
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
Qualifiers
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.
Disqualifiers
Burn as etiology of wound
Acute osteomyelitis requiring active treatment
Known allergy, hypersensitivity, or objection to porcine materials
Pregnant participants
Trial design
Treatments tested in this trial
- Cytal® Wound Matrix
- MicroMatrix®
Treatment groups
Sponsors and collaborators
Benjamin T. Miller
Lead sponsor
The Cleveland Clinic
Sponsor institution