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

NCT06857708 | Recruiting FDA Device

• 1 other identifier: IRB 23-1221
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to readiness for grafting of the wound bed

  From randomization to readiness for grating, up to 12 weeks

Secondary Outcomes (6)

• Relative wound healing as assessed by the Photographic Wound Assessment Tool (PWAT)

  From randomization to readiness for grating, up to 12 weeks

• Assess the relative rate of wound infection, seroma, hematoma, and need for re-intervention (including incision and drainage)

  From randomization to readiness for grating, up to 12 weeks

• To assess the rate of product excision resulting from wound complications, allergic reaction, or intolerance to the product

  From randomization to readiness for grating, up to 12 weeks

• To assess relative rates of wound closure, measured as the proportion of the remaining wound area compared to the starting wound area

  From randomization to readiness for grating, up to 12 weeks

• To assess relative skin graft size as a percentage of starting wound area

  From randomization to readiness for grating, up to 12 weeks

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Device: Cytal® Wound Matrix; Device: MicroMatrix®

Standard of Care Arm

NO INTERVENTION

Interventions

Cytal® Wound Matrix DEVICE

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

Interventional arm

MicroMatrix® DEVICE

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18 years) with a diagnosis of necrotizing fasciitis
• Wound ≥ 30 cm2
• 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.

You may not qualify if:

• Burn as etiology of wound
• Acute osteomyelitis requiring active treatment
• Known allergy, hypersensitivity, or objection to porcine materials
• Pregnant participants
• Lack of English language fluency
• Participant report of concurrent participation in another clinical trial that would interfere with this study
• Inability to consent

Sponsors & Collaborators

• Benjamin T. Miller: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Fasciitis, Necrotizing

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

US (1)