Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
NCT07385313 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-13
Summary
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Conditions
- Soft Tissue Defects
- Soft Tissue Wounds
- Traumatic Soft Tissue Defect
Interventions
- DEVICE
-
Myriad™ applied in conjunction with NPWT
Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
- DEVICE
-
NPWT Alone
Control Arm: NPWT alone ('NPWT')
Sponsors & Collaborators
-
Coalition for National Trauma Research
collaborator OTHER -
Aroa Biosurgery Limited
lead INDUSTRY
Principal Investigators
-
Julie Rizzo, MD · Brooke Army Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-03-31
- Completion
- 2027-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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