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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07558096
Status
Not Yet Recruiting

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Conditions

  • Head and Neck Cancer (H&N)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard Closure (Control) — PROCEDURE
    * Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
  • Avive+ Intervention — PROCEDURE
    * Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure

Study Details

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 Dates

First listed
Apr 30, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Standard Closure (Control)
    * Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
  • Experimental: Avive+ Intervention
    * Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure

Primary Outcome Measure

Clinically Significant Neuropathic Pain at 6 Months - DN4 score [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
John M Le, MD, DDS
205-975-6356

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By research site
University of Alabama at Birmingham· Birmingham, AL

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