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| UAB | Other Identifier | UAB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Closure (Control) | Active Comparator |
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| Avive+ Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
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| Standard Closure (Control) | Procedure |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M Le, MD, DDS | Contact | 205-975-6356 | jle@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| John M Le, MD, DDS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| Avive+ Intervention | Procedure |
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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 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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