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

Starting soon · Not applicable

Conditions studied: Head and Neck Cancer (H&N)

In brief

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.

Key facts

Study ID

NCT07558096

Run by

University of Alabama at Birmingham

People needed

80

Starts

2026-08-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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