MicroMatrix® Flex in Tunneling Wounds

Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining

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

Study Overview

• Status: Completed
• Conditions: Pressure Injury; Venous Ulcer; Necrotizing Soft Tissue Infection; Diabetic Ulcers; Draining Wound
• Intervention / Treatment: Device: MicroMatrix® Flex; Device: MicroMatrix® UBM Particulate; Device: Cytal® Wound Matrix 2-Layer

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Health Research Institute Inc.
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Comprehensive Wound Healing Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 wounds associated with open abdominal procedures, or any indication per the Instructions For Use
3. Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
4. 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

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 would interfere with this study
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with tunneling and/or undermining wounds; MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.

Device: MicroMatrix® Flex; MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), draining wounds. The device is intended for one-time use.; Device: MicroMatrix® UBM Particulate; MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.; Device: Cytal® Wound Matrix 2-Layer; Cytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative rate of closure of a tunneling or undermining feature	Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at 12 weeks or skin graft visit, relative to first visit/application post debridement	At 12 weeks or skin graft visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative rate of closure of a tunneling or undermining feature	Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at each visit, relative to first visit/application post debridement	First device application through to 12 weeks
Relative rate of overall wound closure	Relative rate of overall wound closure as determined manually, through measurement of volume, using the Kundin method, of managed wound at each visit, relative to first visit/application post debridement	First device application through to 12 weeks
Relative rate of overall wound closure	Relative rate of overall wound closure per number of treatments received	First device application through to 12 weeks
Number of wound infections, seromas, and hematomas	Number of wound infections, seromas, and hematomas requiring re-intervention (including incision and drainage)	First device application through to 12 weeks
Number of managed wounds which require removal of devices	Number of managed wounds which require removal of devices due to complications, allergic reactions, or intolerance of devices	First device application through to 12 weeks
Length of stay in-patient	Length of stay in-patient, if applicable	First device application through to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of skin graft	Area of skin graft utilized relative to the original wound size	At skin graft visit, a maximum of 14 weeks from first device application
Skin graft take	Skin graft take percentage at skin graft follow-up	At skin graft visit + (4 weeks ± 7 days)
Time to graft	Time to skin graft	First device application through to skin graft visit

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Claire Witherel, Ph.D., Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Pressure Ulcer
• Other Study ID Numbers: T-MMFLEX-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No