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.
Age ≥ 18 years
Undergoing RFFF for head and neck reconstruction
Treated at University of Alabama at Birmingham
Able to provide informed consent
Reconstruction using a non-RFFF free flap
Pre-existing ipsilateral radial nerve neuropathy
Prior ipsilateral forearm surgery affecting nerve anatomy
Active donor-site infection
Parallel
Standard Closure (Control)
Procedure/Surgery* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
Avive+ Intervention
Procedure/Surgery* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
Clinically Significant Neuropathic Pain at 6 Months - DN4 score
A DN4 questionnaire score of 4 or higher out of 10 indicates a high probability of neuropathic pain. This validated tool, which can be viewed in this DN4 Questionnaire consists of seven patient-interview questions and three clinician-examination items, with a total score distinguishing neuropathic from non-neuropathic pain. A score greater than or equal to 4 is considered positive for neuropathic pain
Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale
Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Average Pain Severity
Numeric Rating Scale (NRS): Commonly used in healthcare to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Average Sensory Function with Semmes-Weinstein monofilament testing
The Semmes-Weinstein monofilament test is a quick, non-invasive, and objective clinical exam used to evaluate nerve function by measuring skin sensitivity to light touch and pressure.
Average Sensory Function with Static 2-point discrimination
Static 2-point discrimination (2PD) is a clinical test measuring the minimum distance at which a patient can perceive two simultaneous touch stimuli as distinct, rather than one, using a device like an aesthesiometer or disk-criminator.
Percentage of Skin Graft Loss
Measured by percentage of 0-100% total graft loss.
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