MicroMatrix® Flex in Tunneling Wounds
Completed · Not applicable
Conditions studied: Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers, Draining Wound
In brief
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
Key facts
- Study ID
- NCT06629506
- Run by
- Integra LifeSciences Corporation
- People needed
- 25
- Starts
- 2024-12-12
- Expected to finish
- 2025-08-31
- Last updated by the study team
- 2026-03-05
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 wounds associated with open abdominal procedures, or any indication per the Instructions For Use
- Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
- Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form
You may not qualify if…
- 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 would interfere with this study
- Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- MedStar Health Research Institute Inc. — Washington D.C., District of Columbia, United States
- Northwell Comprehensive Wound Healing Center — Lake Success, New York, United States
Full record on ClinicalTrials.gov
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