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

NCT06857708 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-03

No results posted yet for this study

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

Interventions

DEVICE

Cytal® Wound Matrix

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

DEVICE

MicroMatrix®

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

Sponsors & Collaborators

  • Benjamin T. Miller

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2026-09-01
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857708 on ClinicalTrials.gov