Necrotizing FascitisNCT06857708
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
A study testing Cytal® Wound Matrix and MicroMatrix® in people with Necrotizing Fascitis and Necrotizing Soft Tissue Infection, run by Benjamin T. Miller at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Fascitis, Necrotizing Soft Tissue Infection
- What is being tested?
- Cytal® Wound Matrix and MicroMatrix®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kimberly Woo, 2163999672, wook2@ccf.org
Benjamin Miller, MD
About this study
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.
Read the 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.
- Being tested
- Cytal® Wound Matrix, MicroMatrix®
- Medical subject headings
- Fasciitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytal® Wound MatrixDevice
This is the only study to use this intervention in necrotizing soft tissue wounds
MicroMatrix®Device
This is the only study to use this intervention in necrotizing soft tissue wounds
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | This arm will receive application of Cytal® Wound Matrix and MicroMatrix® Receives: Device: Cytal® Wound Matrix; Device: MicroMatrix® |
| Standard of Care Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to readiness for grafting of the wound bed
Measured: 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)
Relative wound healing as assessed by the Photographic Wound Assessment Tool (PWAT) between the two study arms
Measured: 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)
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
Measured: 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
Measured: 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
Measured: From randomization to readiness for grating, up to 12 weeks
To assess relative skin graft size as a percentage of starting wound area
Measured: From randomization to readiness for grating, up to 12 weeks
To assess the relative percentages of skin graft take
Measured: From randomization to readiness for grating, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start5 Mar 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin T. Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin T. Miller, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857708
- Sponsor's protocol ID
- IRB 23-1221
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
- ClinicalTrials.gov ID
- NCT06857708
- Acronym / sponsor ID
- IRB 23-1221
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benjamin T. MillerUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Cytal® Wound Matrix, Device: MicroMatrix®This arm will receive application of Cytal® Wound Matrix and MicroMatrix® |
| Standard of Care Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytal® Wound MatrixThis is the only study to use this intervention in necrotizing soft tissue wounds | Device | Interventional arm |
| MicroMatrix®This is the only study to use this intervention in necrotizing soft tissue wounds | Device | Interventional arm |
Primary outcome
Time to readiness for grafting of the wound bed
Time frame: From randomization to readiness for grating, up to 12 weeks
6 secondary outcomes
Relative wound healing as assessed by the Photographic Wound Assessment Tool (PWAT)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From randomization to readiness for grating, up to 12 weeks
To assess relative skin graft size as a percentage of starting wound area
Time frame: From randomization to readiness for grating, up to 12 weeks
To assess the relative percentages of skin graft take
Time frame: From randomization to readiness for grating, up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytal® Wound Matrix and MicroMatrix® in people with Necrotizing Fascitis and Necrotizing Soft Tissue Infection, run by Benjamin T. Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to readiness for grafting of the wound bed (time frame: From randomization to readiness for grating, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.