The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin T. Miller

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Benjamin T. Miller

Lead sponsor

The Cleveland Clinic

Sponsor institution