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Completed

NCT Number: NCT06629506

MicroMatrix® Flex in Tunneling Wounds

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

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Key information

Conditions

Pressure Injury Cardiovascular Diseases Diabetic Ulcers Draining Wound Leg Ulcer Necrotizing Soft Tissue Infection Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Ulcer

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Relative rate of closure of a tunneling or undermining feature

    Time frame: At 12 weeks or skin graft visit

    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

Secondary outcomes

  1. Relative rate of closure of a tunneling or undermining feature

    Time frame: First device application through to 12 weeks

    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

  2. Relative rate of overall wound closure

    Time frame: First device application through to 12 weeks

    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

  3. Relative rate of overall wound closure

    Time frame: First device application through to 12 weeks

    Relative rate of overall wound closure per number of treatments received

  4. Number of wound infections, seromas, and hematomas

    Time frame: First device application through to 12 weeks

    Number of wound infections, seromas, and hematomas requiring re-intervention (including incision and drainage)

  5. Number of managed wounds which require removal of devices

    Time frame: First device application through to 12 weeks

    Number of managed wounds which require removal of devices due to complications, allergic reactions, or intolerance of devices

  6. Length of stay in-patient

    Time frame: First device application through to 12 weeks

    Length of stay in-patient, if applicable

Other outcomes

  1. Area of skin graft

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

    Area of skin graft utilized relative to the original wound size

  2. Skin graft take

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

    Skin graft take percentage at skin graft follow-up

  3. Time to graft

    Time frame: First device application through to skin graft visit

    Time to skin graft

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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