CompletedNot Applicable

MicroMatrix® Flex in Tunneling Wounds

United States25 participantsStarted 2024-12-12

Plain-language summary

To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Relative rate of closure of a tunneling or undermining feature

Timeframe: At 12 weeks or skin graft visit

NCT IDNCT06629506

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-31