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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Burns, Osteomyelitis, Pregnancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for necrotizing fasciitis, a severe skin infection often called "flesh-eating disease." Researchers compare Cytal® Wound Matrix and MicroMatrix® (both wound care products) with standard wound care to determine if these new treatments improve wound healing. Participants must have a wound larger than 30 cm² due to necrotizing fasciitis and be willing to follow the study's guidelines. This study may suit those dealing with large, challenging wounds from this condition. As an unphased trial, it offers a unique opportunity to contribute to innovative wound care research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cytal® Wound Matrix and MicroMatrix® have demonstrated good safety results in past studies. One study found that patients generally tolerated these treatments well. Importantly, no deaths were linked to these products, suggesting they are safe for wound care.

Although this trial is not in a specific phase, an ethics board has approved it, and informed consent is required, indicating that safety is a priority. This approval often reflects the treatments' safety in earlier studies.

Overall, Cytal® Wound Matrix and MicroMatrix® appear to be safe options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cytal® Wound Matrix and MicroMatrix® because they offer a novel approach to treating flesh-eating disease, also known as necrotizing fasciitis. Unlike standard treatments that typically involve surgical removal of infected tissue and broad-spectrum antibiotics, these new treatments focus on enhancing the body's natural healing process. Cytal® Wound Matrix provides a scaffold for tissue regeneration, while MicroMatrix® delivers a fine powder of extracellular matrix particles to support cell growth and repair. This combination has the potential to not only speed up recovery but also improve the quality of healing, reducing the need for extensive surgical interventions.

What evidence suggests that this trial's treatments could be effective for flesh-eating disease?

Research has shown that Cytal® Wound Matrix and MicroMatrix® hold promise for treating wounds. In earlier studies, wounds treated with these products healed significantly. By week 4, the wound size reduced by 40%; by week 8, it reduced by 60%; and by week 12, it reduced by 80%. In this trial, participants in the interventional arm will receive both Cytal® Wound Matrix and MicroMatrix®. Experts believe these treatments might prepare wounds for skin grafts faster than traditional methods. These results suggest that Cytal® Wound Matrix and MicroMatrix® could effectively manage severe infections like flesh-eating disease. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

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

My wound is larger than 30 cm2.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06857708?term=micromatrix&rank=3&checkSpell=

The Management of Necrotizing Soft Tissue Infection ...

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 ...

2.

withpower.com

withpower.com/trial/phase-communicable-diseases-2-2025-cc8a6

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

This N/A medical study run by The Cleveland Clinic is evaluating whether Cytal® Wound Matrix and MicroMatrix® will have tolerable side effects & efficacy ...

3.

trialx.com

trialx.com/clinical-trials/listings/302946/the-management-of-necrotizing-soft-tissue-infection-wounds-with-cytal-wound-matrix-and-micromatrix/

The Management of Necrotizing Soft Tissue Infection ...

The study will consist of 2 arms: treatment with Cytal® Wound Matrix 2-Layer and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03632954

Cytal® Wound Matrix and MicroMatrix® Wound Study

Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12. Up to 12 weeks. Secondary Outcome Measures ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/aefc4a34686d5962/nct06857708-wound-management-cytral-micromatrix

The Management of Necrotizing Soft Tissue Infection Wounds ...

We hypothesize that wound beds treated with Cytal® and MicroMatrix® will have a significantly decreased time to skin graft readiness as compared to those ...

6.

products.integralife.com

products.integralife.com/file/products/clinical-compendium-cytal-micromatrix.pdf

MicroMatrix® and Cytal® Wound Matrix in Clinical Practice

One patient died during follow-up from causes unrelated to the use of UBM-ECM for wound care. RESULTS. 1.7APPLICATIONS. 26.5WEEKS. 100% achieved complete wound ...