MicroMatrix® Flex in Tunneling Wounds

Not Applicable

Recruiting

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

• Registration Number: NCT06629506
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Study Start: 2024-12-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with tunneling and/or undermining wounds	MicroMatrix® Flex	MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
Subjects with tunneling and/or undermining wounds	MicroMatrix® UBM Particulate	MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
Subjects with tunneling and/or undermining wounds	Cytal® Wound Matrix 2-Layer	MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.

Primary Outcome Measures

Name	Time	Method
Relative rate of closure of a tunneling or undermining feature	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 Outcome Measures

Name	Time	Method
Relative rate of closure of a tunneling or undermining feature	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
Relative rate of overall wound closure	First device application through to 12 weeks	Relative rate of overall wound closure per number of treatments received
Number of wound infections, seromas, and hematomas	First device application through to 12 weeks	Number of wound infections, seromas, and hematomas requiring re-intervention (including incision and drainage)
Number of managed wounds which require removal of devices	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
Length of stay in-patient	First device application through to 12 weeks	Length of stay in-patient, if applicable

Trial Locations

Locations (3)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

MedStar Health Research Institute Inc.; 🇺🇸 Washington, District of Columbia, United States

Northwell Comprehensive Wound Healing Center; 🇺🇸 Lake Success, New York, United States