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)

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

Start date

Jul 31, 2026

Status verified

Apr 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

• John M Le, MD, DDS
  205-975-6356
  [email protected]

Locations (1)

Find similar trials in Birmingham, AL

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