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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with tunneling and/or undermining wounds | Experimental | MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroMatrix® Flex | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 12 weeks or skin graft visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | First device application through to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area of skin graft | Area of skin graft utilized relative to the original wound size | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Witherel, Ph.D. | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| MedStar Health Research Institute Inc. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
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|
| MicroMatrix® UBM Particulate | Device | 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 2-Layer | Device | 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 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 |
| First device application through to 12 weeks |
| Relative rate of overall wound closure | Relative rate of overall wound closure per number of treatments received | 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) | 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 | First device application through to 12 weeks |
| Length of stay in-patient | Length of stay in-patient, if applicable | First device application through to 12 weeks |
| At skin graft visit + (4 weeks ± 7 days) |
| Time to graft | Time to skin graft | First device application through to skin graft visit |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Northwell Comprehensive Wound Healing Center | Lake Success | New York | 11042 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |