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

Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
Aurora
Washington, D.c.
MedStar Health Research Institute Inc.
Washington D.c.
New York
Northwell Comprehensive Wound Healing Center
Lake Success
Time Frame
Start Date: 2024-12-12
Completion Date: 2026-03-31
Participants
Target number of participants: 25
Treatments
Experimental: Subjects with tunneling and/or undermining wounds
MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
Related Therapeutic Areas
Sponsors
Leads: Integra LifeSciences Corporation

This content was sourced from clinicaltrials.gov