MicroMatrix® Flex in Tunneling Wounds

Last updated: December 13, 2024
Sponsor: Integra LifeSciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Leg Ulcers

Diabetic Foot Ulcers

Stasis Dermatitis

Treatment

MicroMatrix® Flex

Cytal® Wound Matrix 2-Layer

MicroMatrix® UBM Particulate

Clinical Study ID

NCT06629506
T-MMFLEX-001
  • Ages > 22
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is ≥ 22 years at the time of consent

  2. 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

  3. Patient is willing and able to adhere to protocol requirements and comply with thestudy follow-up regimen

  4. 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:

  1. Burn as etiology of wound

  2. Unmanaged infection and/or osteomyelitis as determined pre-operatively

  3. Known allergy, hypersensitivity, or objection to porcine materials, due to religion,culture, or other

  4. Patient report of concurrent participation in another clinical trial that wouldinterfere with this study

  5. 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

Total Participants: 25
Treatment Group(s): 3
Primary Treatment: MicroMatrix® Flex
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
March 31, 2026

Study Description

The purpose of this study is to evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.

Connect with a study center

  • Northwell Comprehensive Wound Healing Center

    Lake Success, New York 11042
    United States

    Active - Recruiting

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