Not Yet RecruitingNot Applicable

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

United States80 participantsStarted 2026-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Undergoing RFFF for head and neck reconstruction * Treated at University of Alabama at Birmingham * Able to provide informed consent * Willing to comply with follow-up Exclusion Criteria: * Reconstruction using a non-RFFF free flap * Pre-existing ipsilateral radial nerve neuropathy * Prior ipsilateral forearm surgery affecting nerve anatomy * Active donor-site infection * Severe peripheral vascular disease * Inability to complete follow-up

What they're measuring

Clinically Significant Neuropathic Pain at 6 Months - DN4 score

Timeframe: 6 months

Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale

Timeframe: 6 months

Trial details

NCT IDNCT07558096

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

John M Le, MD, DDS

205-975-6356 jle@uabmc.edu

View on ClinicalTrials.gov More Head and Neck Cancer (H&N) trials