MicroMatrix® Flex in Tunneling Wounds

Integra LifeSciences

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06629506

T-MMFLEX-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Subjects with tunneling and/or undermining wounds

Experimental group

Description:

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

Treatment:

Device: MicroMatrix® UBM Particulate

Device: Cytal® Wound Matrix 2-Layer

Device: MicroMatrix® Flex