To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
MedStar Health Research Institute Inc.
Washington D.C., District of Columbia, United States
Northwell Comprehensive Wound Healing Center
Lake Success, New York, United States
Relative rate of closure of a tunneling or undermining feature
Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at 12 weeks or skin graft visit, relative to first visit/application post debridement
Time frame: At 12 weeks or skin graft visit
Relative rate of closure of a tunneling or undermining feature
Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at each visit, relative to first visit/application post debridement
Time frame: First device application through to 12 weeks
Relative rate of overall wound closure
Relative rate of overall wound closure as determined manually, through measurement of volume, using the Kundin method, of managed wound at each visit, relative to first visit/application post debridement
Time frame: First device application through to 12 weeks
Relative rate of overall wound closure
Relative rate of overall wound closure per number of treatments received
Time frame: First device application through to 12 weeks
Number of wound infections, seromas, and hematomas
Number of wound infections, seromas, and hematomas requiring re-intervention (including incision and drainage)
Time frame: First device application through to 12 weeks
Number of managed wounds which require removal of devices
Number of managed wounds which require removal of devices due to complications, allergic reactions, or intolerance of devices
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: First device application through to 12 weeks
Length of stay in-patient
Length of stay in-patient, if applicable
Time frame: First device application through to 12 weeks