Head and Neck Cancer (H&N)
Conditions
Keywords
Head and Neck Cancer, Radial forearm free flap, Neuropathic pain, Superficial radial nerve, Donor site morbidity, Soft tissue matrix
Brief 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.
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.
Interventions
PROCEDUREStandard Closure (Control)
* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
PROCEDUREAvive+ Intervention
* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Neuropathic Pain at 6 Months - DN4 score | 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 |
| Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale | 6 months | Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Severity | 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" |
| Average Sensory Function with Semmes-Weinstein monofilament testing | 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. |
| Average Sensory Function with Static 2-point discrimination | 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. |
| Percentage of Skin Graft Loss | up to 3 months | Measured by percentage of 0-100% total graft loss. |
| Number of Participants that develop Infection | Up to 3 months | Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics. |
| Number of participants with Tendon Exposure | up to 3 months | Measured by number of participants with visual appearance of tendon exposure. |
| Change in QuickDASH score | 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). |
Countries
United States
Contacts
CONTACTJohn M Le, MD, DDS
PRINCIPAL_INVESTIGATORJohn M Le, MD, DDS
University of Alabama at Birmingham
Outcome results
None listed