MicroMatrix® Flex in Tunneling Wounds

Description

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, Necrotizing Soft Tissue Infection, Diabetic Ulcers, Draining Wound

Study Overview

Study Details

Study overview

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

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

MicroMatrix® Flex in Tunneling Wounds

Condition
Pressure Injury
Intervention / Treatment

-

Contacts and Locations

Lake Success

Northwell Comprehensive Wound Healing Center, Lake Success, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Integra LifeSciences Corporation,

Claire Witherel, Ph.D., STUDY_DIRECTOR, Integra LifeSciences Corporation

Study Record Dates

2026-03-31