ConditionHead and Neck Cancer (H&N)
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 groupsSponsors and collaborators
Source ClinicalTrials.gov