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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer (H&N)
• Intervention / Treatment: Procedure: Standard Closure (Control); Procedure: Avive+ Intervention

Detailed Description

Radial forearm free flap (RFFF) harvest is associated with significant donor-site morbidity, including neuropathic pain, hypoesthesia, and functional impairment related to superficial radial nerve irritation and postoperative scar formation. Current donor-site management focuses on wound closure and healing but does not directly address nerve protection.

Avive+ Soft Tissue Matrix is a human-derived biologic material designed for soft tissue reinforcement and protection. Its use as a barrier over surgically manipulated nerves is biologically plausible but has not been studied in this clinical context.

This study is a prospective, randomized controlled pilot trial designed to evaluate the feasibility, safety, and preliminary efficacy of Avive+ placement over the superficial radial nerve during RFFF harvest. Subjects will be randomized to standard closure versus Avive+ placement plus standard closure. Outcomes will focus on neuropathic pain, sensory function, and wound complications.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John M Le, MD, DDS; Phone Number: 205-975-6356; Email: jle@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: John M Le, MD, DDS; Phone Number: 205-975-6356

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Closure (Control); Standard RFFF harvest; Split-thickness skin graft (STSG) donor-site closure	Procedure: 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	Procedure: Avive+ Intervention; Standard RFFF harvest; Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve; STSG donor-site closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Significant Neuropathic Pain at 6 Months - DN4 score	A DN4 questionnaire score of 4 or higher out of 10 indicates a high probability of neuropathic pain. This validated tool, which can be viewed in this DN4 Questionnaire consists of seven patient-interview questions and three clinician-examination items, with a total score distinguishing neuropathic from non-neuropathic pain. A score greater than or equal to 4 is considered positive for neuropathic pain	6 months
Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale	Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Severity	Numeric Rating Scale (NRS): Commonly used in healthcare to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"	1, 3, 6, and 12 months
Average Sensory Function with Semmes-Weinstein monofilament testing	The Semmes-Weinstein monofilament test is a quick, non-invasive, and objective clinical exam used to evaluate nerve function by measuring skin sensitivity to light touch and pressure.	1, 3, 6, and 12 months
Average Sensory Function with Static 2-point discrimination	Static 2-point discrimination (2PD) is a clinical test measuring the minimum distance at which a patient can perceive two simultaneous touch stimuli as distinct, rather than one, using a device like an aesthesiometer or disk-criminator.	1, 3, 6, and 12 months
Percentage of Skin Graft Loss	Measured by percentage of 0-100% total graft loss.	up to 3 months
Number of Participants that develop Infection	Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics.	Up to 3 months
Number of participants with Tendon Exposure	Measured by number of participants with visual appearance of tendon exposure.	up to 3 months
Change in QuickDASH score	The QuickDASH is an 11-item questionnaire assessing upper limb musculoskeletal disability, scoring from 0 (no disability) to 100 (most severe).	3, 6, and 12 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: John M Le, MD, DDS, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Neuropathic pain; Radial forearm free flap; Superficial radial nerve; Donor site morbidity; Soft tissue matrix
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Head and Neck Neoplasms
• Other Study ID Numbers: IRB-300016607; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No