Phase
Condition
Venous Leg Ulcers
Diabetic Foot Ulcers
Stasis Dermatitis
Treatment
MicroMatrix® Flex
Cytal® Wound Matrix 2-Layer
MicroMatrix® UBM Particulate
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is ≥ 22 years at the time of consent
Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer,necrotizing soft tissue infection associated wound, dehiscing and/or draining woundsassociated with open abdominal procedures, or any indication per the InstructionsFor Use
Patient is willing and able to adhere to protocol requirements and comply with thestudy follow-up regimen
Patient has reviewed the IRB/IEC-approved consent form, has been properly consentedper the protocol and has documented their consent to participate in the study bysigning the IRB/IEC-approved consent form
Exclusion
Exclusion Criteria:
Burn as etiology of wound
Unmanaged infection and/or osteomyelitis as determined pre-operatively
Known allergy, hypersensitivity, or objection to porcine materials, due to religion,culture, or other
Patient report of concurrent participation in another clinical trial that wouldinterfere with this study
Any condition, concomitant medication, or concomitant treatment that, in the opinionof the investigator, would preclude the use of the study device or preclude thepatient from completing the follow-up requirements
Study Design
Study Description
Connect with a study center
Northwell Comprehensive Wound Healing Center
Lake Success, New York 11042
United StatesActive - Recruiting
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