Avive+ Soft Tissue Matrix for Neuropathic Pain

This trial tests a new soft tissue matrix called Avive+ to determine if it can reduce pain and improve sensation in individuals who have undergone radial forearm free flap (RFFF) reconstruction. This surgery often results in nerve pain and sensory issues at the donor site. Participants will receive either the Avive+ treatment or a standard closure for comparison. Those who have had RFFF surgery for head and neck reconstruction and can visit the University of Alabama at Birmingham may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical outcomes for future patients.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that Avive+ Soft Tissue Matrix is generally safe for soft tissue repair. This specialized tissue protects nerves and aids in healing. Studies have found that it can improve surgical outcomes involving nerves, such as reducing pain over time.

Unlike the standard of care for neuropathic pain, which often involves medications like anticonvulsants or antidepressants, the Avive+ Soft Tissue Matrix offers a novel approach by directly targeting the superficial radial nerve. This innovative treatment is applied over the nerve during surgery, potentially reducing nerve-related pain by promoting healing and reducing scar tissue formation. Researchers are excited about Avive+ because it promises a more direct and potentially faster method of pain relief, with the added benefit of addressing the source of nerve pain rather than just managing symptoms.

This trial will compare the Avive+ Soft Tissue Matrix with a standard closure method for managing neuropathic pain. Studies have shown that the Avive+ Soft Tissue Matrix can reduce pain and improve nerve function. In one study, patients who underwent nerve surgeries and used Avive+ reported a significant drop in pain levels, improving by nearly 2 points on a pain scale. Another study found that Avive+ helps keep tissues apart, reducing nerve sticking that can cause pain. Additionally, patients noticed a clear decrease in limb and phantom pain after using this treatment. These findings suggest that Avive+ may effectively reduce nerve-related pain and improve sensation in cases like radial forearm free flap reconstructions.¹³⁴⁶⁷