MicroMatrix® Flex in Tunneling Wounds

Launched by INTEGRA LIFESCIENCES CORPORATION · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MicroMatrix® Flex, which is designed to help heal wounds that have complications like tunneling or undermining. These types of wounds can occur from various conditions such as pressure injuries, venous ulcers, diabetic ulcers, and certain infections. The trial aims to evaluate how safe and effective this treatment is for people aged 22 and older who are dealing with these specific types of wounds.

To participate in this study, participants need to be at least 22 years old and have one of the qualifying wound conditions mentioned earlier. They should also be willing to follow the study's guidelines and attend follow-up appointments. Those who have burns as the cause of their wounds or certain infections that are not managed will not be eligible. If someone joins the study, they can expect to receive the MicroMatrix® Flex treatment and will be closely monitored throughout the process to assess how well it works. This trial is currently recruiting participants, and it welcomes people of all genders.

Gender

ALL

Eligibility criteria

• 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