Pilot randomized trial of Avive+ amnion soft‑tissue barrier to reduce radial nerve morbidity

This University of Alabama at Birmingham (UAB) single-blind, randomized, parallel-group pilot study tests whether adding Avive+ Soft Tissue Matrix to the radial forearm free flap (RFFF) donor site can reduce superficial radial nerve–related neuropathic pain and sensory disturbance after flap harvest for resectable head and neck cancer reconstruction. All participants undergo standard RFFF harvest with split-thickness skin graft (STSG) closure; the experimental arm additionally receives Avive+ placed over the superficial radial nerve. Avive+ (Axogen) is a multilayer amnion allograft intended to act as a temporary soft-tissue barrier, separating adjacent tissues and potentially reducing adhesions/nerve tethering during healing (a physical “anti-adhesion” mechanism rather than a drug-like receptor target). The main commercial/scientific angle is translating a peripheral-nerve protection product into a head-and-neck microvascular reconstruction workflow where donor-site nerve irritation can be a durable quality-of-life issue. Today’s care after RFFF harvest is meticulous nerve identification/preservation plus STSG-based donor-site closure, with symptomatic neuropathic pain managed reactively using analgesics and neuropathic agents rather than a prophylactic nerve-protection implant.