MicroMatrix® Flex in Tunneling Wounds

NCT06629506 | Completed FDA Device

• 1 other identifier: T-MMFLEX-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pressure Injury; Venous Ulcer; Diabetic Ulcers; Necrotizing Soft Tissue Infection; Draining Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Relative rate of closure of a tunneling or undermining feature

  First device application through to 12 weeks

• Relative rate of overall wound closure

  First device application through to 12 weeks

• Relative rate of overall wound closure

  First device application through to 12 weeks

• Number of wound infections, seromas, and hematomas

  First device application through to 12 weeks

• Number of managed wounds which require removal of devices

  First device application through to 12 weeks

Other Outcomes (3)

• Area of skin graft

  At skin graft visit, a maximum of 14 weeks from first device application

• Skin graft take

  At skin graft visit + (4 weeks ± 7 days)

• Time to graft

  First device application through to skin graft visit

Study Arms (1)

Subjects with tunneling and/or undermining wounds

EXPERIMENTAL

MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.

Device: MicroMatrix® Flex; Device: MicroMatrix® UBM Particulate; Device: Cytal® Wound Matrix 2-Layer

Interventions

MicroMatrix® Flex DEVICE

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.

Subjects with tunneling and/or undermining wounds

MicroMatrix® UBM Particulate DEVICE

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.

Subjects with tunneling and/or undermining wounds

Cytal® Wound Matrix 2-Layer DEVICE

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.

Subjects with tunneling and/or undermining wounds

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (3)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MedStar Health Research Institute Inc.

Washington D.C., District of Columbia, 20007, United States

Location

Northwell Comprehensive Wound Healing Center

Lake Success, New York, 11042, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer

Study Officials

• Claire Witherel, Ph.D.

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: December 12, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)