Using MicroMatrix® Flex for treating complex wounds
Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining
This study is testing if MicroMatrix® Flex can help heal complex wounds better and safer over 12 weeks, while also checking how well skin grafts work when needed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Integra LifeSciences Corporation Industry-sponsored |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT06629506 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of MicroMatrix® Flex in patients with wounds that have tunneling or undermining features. It involves collecting prospective data to measure the reduction in wound area and volume over a 12-week period, as well as monitoring for post-operative complications. Additionally, the study will assess the success rate of skin grafts when applicable, with follow-up extending up to 16 weeks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22 and older with specific types of wounds such as pressure injuries, venous ulcers, or diabetic ulcers.
Not a fit: Patients with burns, unmanaged infections, or known allergies to porcine materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients with complex wounds.
How similar studies have performed: Other studies have shown promising results with similar wound treatment approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 2 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- MedStar Health Research Institute Inc. — Washington, District of Columbia, United States (Recruiting)
- Northwell Comprehensive Wound Healing Center — Lake Success, New York, United States (Recruiting)
Study contacts
- Study coordinator: Saarah Mohammedi Alseginy
- Email: saarah.mohammedialseginy@integralife.com
- Phone: 609-216-4587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.