Trials Today

MicroMatrix® Flex in Tunneling Wounds

Purpose

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

Eligibility

Eligible Ages: Over 22 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Device: MicroMatrix® Flex MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), draining wounds. The device is intended for one-time use. Device: MicroMatrix® UBM Particulate MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use. Device: Cytal® Wound Matrix 2-Layer Cytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.

Recruiting Locations

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045

Contact:
Alyssa CALDWELL-MCGEE
ALYSSA.CALDWELL-MCGEE@CUANSCHUTZ.EDU

MedStar Health Research Institute Inc.
Washington, District of Columbia 20007

Contact:
Alison Ross
Alison.R.Ross@medstar.net

Northwell Comprehensive Wound Healing Center
Lake Success, New York 11042

Contact:
Sally Kaplan
skaplan2@northwell.edu

More Details

NCT ID: NCT06629506
Status: Recruiting
Sponsor: Integra LifeSciences Corporation

Study Contact

Saarah Mohammedi Alseginy
609-216-4587
saarah.mohammedialseginy@integralife.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.