Recruiting

Cytal® & MicroMatrix®

Sponsor:

Benjamin T. Miller

Code:

NCT06857708

Conditions

Necrotizing Fascitis

Necrotizing Soft Tissue Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cytal® Wound Matrix

MicroMatrix®

Study Details

Brief summary:

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

Study ID

NCT06857708

Start date

Mar 5, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional arm

This arm will receive application of Cytal® Wound Matrix and MicroMatrix®

no intervention: Standard of Care Arm

Interventions

Cytal® Wound Matrix

This is the only study to use this intervention in necrotizing soft tissue wounds

MicroMatrix®

This is the only study to use this intervention in necrotizing soft tissue wounds

Primary outcome measure

  • Time to readiness for grafting of the wound bed [ Time Frame: From randomization to readiness for grating, up to 12 weeks ]

Central Contacts and Locations

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kimberly Woo

2163999672wook2@ccf.org

Principal Investigator:

Benjamin Miller, MD

More Information

Sponsor

Benjamin T. Miller

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benjamin T. Miller on 2026-04-03.