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NOT YET RECRUITING
NCT07558096
NA

A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-07

Completion Date

2029-12

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

PROCEDURE

Standard Closure (Control)

* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure

PROCEDURE

Avive+ Intervention

* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States