The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin T. Miller
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Burn as etiology of wound
Acute osteomyelitis requiring active treatment
Known allergy, hypersensitivity, or objection to porcine materials
Pregnant participants
Trial design
Design model
Parallel
Treatments tested in this trial
Cytal® Wound Matrix
DeviceThis is the only study to use this intervention in necrotizing soft tissue wounds
MicroMatrix®
DeviceThis is the only study to use this intervention in necrotizing soft tissue wounds
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Interventional armExperimental treatment 2 interventions
Group B: Standard of Care ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time to readiness for grafting of the wound bed
Time frame
From randomization to readiness for grating, up to 12 weeksSecondary outcomes
1
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
Time frame
From randomization to readiness for grating, up to 12 weeks2
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
Time frame
From randomization to readiness for grating, up to 12 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Benjamin T. Miller
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov