Clinical trial NCT06629506: MicroMatrix® Flex in Tunneling Wounds
Official title: Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pressure Injury
Venous Ulcer
Necrotizing Soft Tissue Infection
Diabetic Ulcers
Draining Wound
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative rate of closure of a tunneling or undermining feature
timeFrame: At 12 weeks or skin graft visit
Secondary outcomes:
measure: Relative rate of closure of a tunneling or undermining feature
timeFrame: First device application through to 12 weeks
measure: Relative rate of overall wound closure
timeFrame: First device application through to 12 weeks
measure: Relative rate of overall wound closure
timeFrame: First device application through to 12 weeks
measure: Number of wound infections, seromas, and hematomas
timeFrame: First device application through to 12 weeks
measure: Number of managed wounds which require removal of devices
timeFrame: First device application through to 12 weeks
measure: Length of stay in-patient
timeFrame: First device application through to 12 weeks
Other outcomes:
measure: Area of skin graft
timeFrame: At skin graft visit, a maximum of 14 weeks from first device application
measure: Skin graft take
timeFrame: At skin graft visit + (4 weeks ± 7 days)
measure: Time to graft
timeFrame: First device application through to skin graft visit
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: MedStar Health Research Institute Inc.
state: District of Columbia
city: Lake Success
country: United States
facility: Northwell Comprehensive Wound Healing Center
state: New York
Study officials:
affiliation: Integra LifeSciences Corporation
name: Claire Witherel, Ph.D.
role: STUDY_DIRECTOR
References: