MedTrace Logo

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

NCT07558096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Head and Neck Cancer (H&N)

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • John M Le, MD, DDS · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558096 on ClinicalTrials.gov