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

Not Applicable

Recruiting

• Conditions: Necrotizing Fascitis; Necrotizing Soft Tissue Infection

• Registration Number: NCT06857708
• Lead Sponsor: Benjamin T. Miller

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.

Study Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Status Verified: 2025-03
• Study First Posted: 2025-03-04
• Study Start: 2025-03-05
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to readiness for grafting of the wound bed	From randomization to readiness for grating, up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Relative wound healing as assessed by the Photographic Wound Assessment Tool (PWAT)	From randomization to readiness for grating, up to 12 weeks	Relative wound healing as assessed by the Photographic Wound Assessment Tool (PWAT) between the two study arms
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 relative rate of wound infection, seroma, hematoma, and need for re-intervention (including incision and drainage) between the treated and untreated wound beds
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
To assess the relative percentages of skin graft take	From randomization to readiness for grating, up to 12 weeks

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States