Diabetic Ulcers, Draining Wound, Necrotizing Soft Tissue Infection, Pressure Injury, Venous Ulcer
Conditions
Brief summary
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
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.
Interventions
DEVICEMicroMatrix® 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.
DEVICEMicroMatrix® 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.
DEVICECytal® 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.
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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
1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative rate of closure of a tunneling or undermining feature | At 12 weeks or skin graft visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative rate of closure of a tunneling or undermining feature | First device application through to 12 weeks | 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 |
| Relative rate of overall wound closure | First device application through to 12 weeks | 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 |
| Number of wound infections, seromas, and hematomas | First device application through to 12 weeks | Number of wound infections, seromas, and hematomas requiring re-intervention (including incision and drainage) |
| Number of managed wounds which require removal of devices | First device application through to 12 weeks | Number of managed wounds which require removal of devices due to complications, allergic reactions, or intolerance of devices |
| Length of stay in-patient | First device application through to 12 weeks | Length of stay in-patient, if applicable |
Countries
United States
Contacts
STUDY_DIRECTORClaire Witherel, Ph.D.
Integra LifeSciences Corporation
Outcome results
None listed