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NCT07558096
Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
Conditions: Head and Neck Cancer (H&N)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07558096). StuddyBuddy aggregates publicly available trial information.