Cytal® Wound Matrix + MicroMatrix® for Flesh-Eating Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of 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

Adults over 18 with necrotizing fasciitis (flesh-eating disease) and a wound size of at least 30 cm2 can join this study. They must be willing to follow the trial's procedures and attend all follow-up appointments.

Inclusion Criteria

I am 18 or older with a diagnosis of necrotizing fasciitis.

I am willing and able to follow the study's requirements and attend all follow-ups.

My wound is larger than 30 cm2.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cytal® Wound Matrix and MicroMatrix® or standard of care dressings, with repeated debridement every 24-48 hours

Up to 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of wound infection, seroma, hematoma, and need for re-intervention

4 weeks

Treatment Details

Interventions

• Cytal® Wound Matrix
• MicroMatrix®

Trial Overview The trial is testing Cytal® Wound Matrix and MicroMatrix® against standard care dressings for treating flesh-eating bacteria wounds. It's a randomized controlled trial, meaning participants are randomly assigned to one of two groups.

Participant Groups

Group I: Interventional arm Experimental Treatment 2 Interventions

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

Group II: Standard of Care Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Benjamin T. Miller

Lead Sponsor

Trials

3

Recruited

350+