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

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

No Placebo Group

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.

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional armExperimental Treatment2 Interventions

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

Group II: Standard of Care ArmActive Control1 Intervention