A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
University of Alabama at Birmingham
Summary
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.
Description
Radial forearm free flap (RFFF) harvest is associated with significant donor-site morbidity, including neuropathic pain, hypoesthesia, and functional impairment related to superficial radial nerve irritation and postoperative scar formation. Current donor-site management focuses on wound closure and healing but does not directly address nerve protection. Avive+ Soft Tissue Matrix is a human-derived biologic material designed for soft tissue reinforcement and protection. Its use as a barrier over surgically manipulated nerves is biologically plausible but has not been studied in this clinical…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Undergoing RFFF for head and neck reconstruction * Treated at University of Alabama at Birmingham * Able to provide informed consent * Willing to comply with follow-up Exclusion Criteria: * Reconstruction using a non-RFFF free flap * Pre-existing ipsilateral radial nerve neuropathy * Prior ipsilateral forearm surgery affecting nerve anatomy * Active donor-site infection * Severe peripheral vascular disease * Inability to complete follow-up
Interventions
- ProcedureStandard Closure (Control)
* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
- ProcedureAvive+ Intervention
* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
Location
- University of Alabama at BirminghamBirmingham, Alabama