Avive+ Soft Tissue Matrix for Neuropathic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
Radial forearm free flap (RFFF) reconstruction is commonly used for head and neck defects but is associated with donor-site morbidity, including neuropathic pain and sensory disturbance. This randomized controlled pilot study evaluates whether placement of a soft tissue matrix over the superficial radial nerve at the donor site reduces neuropathic pain and improves sensory outcomes compared to standard closure alone.
Who Is on the Research Team?
John M Le, MD, DDS
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo radial forearm free flap (RFFF) harvest with either standard closure or Avive+ Soft Tissue Matrix placement
Follow-up
Participants are monitored for neuropathic pain, sensory function, and wound complications
Extended Follow-up
Participants continue to be monitored for long-term outcomes such as sensory function and graft loss
What Are the Treatments Tested in This Trial?
Interventions
- Avive+ Soft Tissue Matrix
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
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