An interventional study of MicroMatrix® Flex and MicroMatrix® UBM Particulate in Pressure Injury, Venous Ulcer and Necrotizing Soft Tissue Infection, sponsored by Integra LifeSciences Corporation. Completed at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Integra LifeSciences Corporation · Not applicable, Interventional, and Treatment
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
Device: MicroMatrix® Flex · Device: MicroMatrix® UBM Particulate · Device: Cytal® Wound Matrix 2-Layer
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.
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.
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
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
Area of skin graft
Area of skin graft utilized relative to the original wound size
Time frame: At skin graft visit, a maximum of 14 weeks from first device application
Skin graft take
Skin graft take percentage at skin graft follow-up
Time frame: At skin graft visit + (4 weeks ± 7 days)
Time to graft
Time to skin graft
Time frame: First device application through to skin graft visit
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Aug 2025, 8 months.
Of 30 industry-sponsored interventional studies with no phase under Pressure Ulcer, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 8 months is below that.
Counting every sponsor, half of 209 studies reached it within 11 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Integra LifeSciences Corporation →