Actively Recruiting
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Led by Aroa Biosurgery Limited · Updated on 2026-04-13
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Aroa Biosurgery Limited
Lead Sponsor
C
Coalition for National Trauma Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
CONDITIONS
Official Title
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with study requirements
- Male or female patients aged 18 years or older
- Require reconstruction of a full thickness soft tissue defect with exposed bone, tendon, or neurovascular structures on upper or lower extremity
- Total defect size between 25 and 800 cm2
You will not qualify if you...
- Known sensitivity to ovine (sheep) derived material
- Pregnant or lactating females
- Prisoners
- Likely unable to complete the study
- Unlikely to comply with the study protocol
- Participation in another clinical study within 30 days prior to enrollment making them unsuitable
- Any condition or illness deemed unsuitable by the Investigator
- Obesity with BMI greater than 45
- Blood glucose 350 mg/dL or higher at admission
- History of chronic peripheral vascular disease
- Current immunosuppression
- Recent neoadjuvant chemotherapy or radiotherapy
- Use of cell/tissue-based product or skin substitute at wound site within 30 days before screening
- Defect caused by a third degree burn
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Colorado-Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
L
Lizette Villarreal, MA
CONTACT
S
Serina Zorilla, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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