A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinically Significant Neuropathic Pain at 6 Months - DN4 score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard Closure (Control)
- Standard RFFF harvest
- Split-thickness skin graft (STSG) donor-site closure
干预措施: Standard Closure (Control) (Procedure)
Avive+ Intervention
- Standard RFFF harvest
- Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve
- STSG donor-site closure
干预措施: Avive+ Intervention (Procedure)
结局指标
主要结局
Clinically Significant Neuropathic Pain at 6 Months - DN4 score
时间窗: 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
时间窗: 6 months
Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
次要结局
- Average Pain Severity(1, 3, 6, and 12 months)
- Average Sensory Function with Semmes-Weinstein monofilament testing(1, 3, 6, and 12 months)
- Average Sensory Function with Static 2-point discrimination(1, 3, 6, and 12 months)
- Percentage of Skin Graft Loss(up to 3 months)
- Number of Participants that develop Infection(Up to 3 months)
- Number of participants with Tendon Exposure(up to 3 months)
- Change in QuickDASH score(3, 6, and 12 months)
研究者
John M Le
Assistant Professor
University of Alabama at Birmingham