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

Description

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.

Conditions

Necrotizing Fascitis, Necrotizing Soft Tissue Infection

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Necrotizing Fascitis
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Benjamin T. Miller,

Study Record Dates

2026-12-31