Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About 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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Undergoing RFFF for head and neck reconstruction

Treated at University of Alabama at Birmingham

Able to provide informed consent

Disqualifiers

Reconstruction using a non-RFFF free flap

Pre-existing ipsilateral radial nerve neuropathy

Prior ipsilateral forearm surgery affecting nerve anatomy

Active donor-site infection

Trial design

Treatments tested in this trial

  • Standard Closure (Control)
  • Avive+ Intervention

Treatment groups

80 Participants
are divided into 2 treatment groups