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NCT Number: NCT07558096

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.

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Key information

Conditions

Head and Neck Cancer (H&N) Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location contact

John M Le, MD, DDS

CONTACT

205-975-6356

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Clinically Significant Neuropathic Pain at 6 Months - DN4 score

    Time frame: 6 months

    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

  2. Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale

    Time frame: 6 months

    Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"

Secondary outcomes

  1. Average Pain Severity

    Time frame: 1, 3, 6, and 12 months

    Numeric Rating Scale (NRS): Commonly used in healthcare to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"

  2. Average Sensory Function with Semmes-Weinstein monofilament testing

    Time frame: 1, 3, 6, and 12 months

    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.

  3. Average Sensory Function with Static 2-point discrimination

    Time frame: 1, 3, 6, and 12 months

    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.

  4. Percentage of Skin Graft Loss

    Time frame: up to 3 months

    Measured by percentage of 0-100% total graft loss.

  5. Number of Participants that develop Infection

    Time frame: Up to 3 months

    Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics.

  6. Number of participants with Tendon Exposure

    Time frame: up to 3 months

    Measured by number of participants with visual appearance of tendon exposure.

  7. Change in QuickDASH score

    Time frame: 3, 6, and 12 months

    The QuickDASH is an 11-item questionnaire assessing upper limb musculoskeletal disability, scoring from 0 (no disability) to 100 (most severe).

Study contacts

Contact information is provided by the study sponsor or research team.

John M Le, MD, DDS

CONTACT

[email protected]

205-975-6356

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 30, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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