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

NCT ID: NCT06857708

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2026-12-31

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.

Detailed Description

Necrotizing fasciitis (NF) is a type of soft tissue infection that is characterized by necrosis of the subcutaneous tissues and muscle fascia. Prompt diagnosis and surgical exploration are crucial in the management of these potentially fatal infections.1,2 For most patients, this requires an initial extensive, wide debridement with repeated inspection and debridement every 24-48 hours to remove all necrotic tissue.3 As a result, tissue reconstruction often necessitates flap surgery with autologous, split-thickness skin grafting (STSG) for sufficient coverage. The process during which the wound bed becomes ready for skin grafting can be lengthy, arduous, and often times costly. Post-discharge regimens may consist of pain management for daily dressing changes, nutritional supplements, multiple follow up visits in clinic and likely the involvement of a plastic and reconstructive surgeon.4 Therefore, strategies to promote the healing of these wounds may significantly improve the morbidity of this disease.

One such adjunct to the management of wounds is the use of mammalian-derived extracellular matrices (ECM). Multiple published case reports have demonstrated the safety and efficacy of ECM in the healing process of complex wounds.5-12 A randomized controlled trial was conducted in patients with chronic venous ulcers using an ECM derived from the submucosal layers of the porcine jejunum.8 Their findings demonstrated significant improvement in wound healing as compared to a standard-care group at 12 weeks of treatment (55% vs 34%, p = 0.196).

Cytal® and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, U.S.A.) are acellular, ECM products derived from porcine bladder epithelial basement membrane and tunica propria. It is thought that these products provide an optimal environment for healing by providing a scaffold for tissue regeneration and promoting neovascularization. These products have previously been demonstrated to improve healing in NF wounds.9-12 However, to date, there have been no randomized controlled trials evaluating the efficacy of ECM in the healing of NF 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 treated with standard of care wound management.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional arm

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

Group Type: EXPERIMENTAL

Cytal® Wound Matrix

Intervention Type: DEVICE

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

MicroMatrix®

Intervention Type: DEVICE

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

Standard of Care Arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cytal® Wound Matrix

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

Intervention Type: DEVICE

MicroMatrix®

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults (≥ 18 years) with a diagnosis of necrotizing fasciitis

2. Wound ≥ 30 cm2

3. 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.

Exclusion Criteria

1. Burn as etiology of wound

2. Acute osteomyelitis requiring active treatment

3. Known allergy, hypersensitivity, or objection to porcine materials

4. Pregnant participants

5. Lack of English language fluency

6. Participant report of concurrent participation in another clinical trial that would interfere with this study

7. Inability to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benjamin T. Miller

OTHER

Sponsor Role: lead

Responsible Party

Benjamin T. Miller

Assistant Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Kimberly Woo

Role: primary

wook2@ccf.org

2163999672

Other Identifiers

IRB 23-1221

Identifier Type: -

Identifier Source: org_study_id