Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Aroa Biosurgery Limited
Study ID
NCT07385313
Phase
PHASE4
Status
Recruiting
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Conditions

  • Soft Tissue Defects
  • Soft Tissue Wounds
  • Traumatic Soft Tissue Defect

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Myriad™ applied in conjunction with NPWT — DEVICE
    Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
  • NPWT Alone — DEVICE
    Control Arm: NPWT alone ('NPWT')

Study Details

Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional Arm
    Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
  • Active Comparator: Control Arm
    NPWT alone ('NPWT')

Primary Outcome Measure

Tissue Coverage [ Time Frame: Up to 56 days/ 8 week follow up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado-Anschutz Medical CampusAuroraColorado80045
Alyssa Caldwell-McGee
[email protected]
303-517-2669
Tracey MacDermott
[email protected]
(303)724-2757
Michael Cripps, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Stephanie DeMoor
[email protected]
210-743-4147
Rachelle Jonas
[email protected]
2107434144
Susannah Nicholson, MD (PRINCIPAL_INVESTIGATOR)

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