Comparison of Functional Outcomes and Morbidity of the Radial Forearm Versus the Ulnar Forearm Free Flap: A Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Average Key Pinch Strength (lbs) in the operative hand and non-operative hand
研究概览
简要总结
This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction.
详细描述
The radial forearm free flap and the ulnar forearm free flap are both well-described procedures used for free tissue transfer in reconstructive surgery. Although forearm free flaps are frequently performed, there is insufficient prospective data looking at the morbidity of the radial compared to ulnar forearm free flaps. The goal of this research study is to characterize the outcomes for each of these two flaps, and to determine if there is surgical equipoise, or if one flap is better than the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
To the extend possible based on the nature of the study, subjects and researchers will be masked from the treatment arms.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with planned forearm free flap reconstruction
- •Patients who are deemed equal surgical candidates for radial forearm free flap and ulnar forearm free flap reconstruction
- •Preoperative Allen's test completed and passed
- •Patients have the capacity to complete the informed consent process
排除标准
- •Patients that are not candidates for a forearm flap based on their physiology
- •Clinically evident peripheral neuropathy (e.g., diabetic neuropathy, leprosy)
- •Patients requiring concurrent forearm bone for reconstruction
- •Child, prisoner, or other vulnerable group
结局指标
主要结局
Average Key Pinch Strength (lbs) in the operative hand and non-operative hand
时间窗: up to 6 months
Subjects' pinch strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied with key pinch in pounds.
Average Physician and Patient Rating of Scar Appearance
时间窗: up to 6 months
Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10.
Average Static Two Point Discrimination (mm)
时间窗: up to 6 months
Subjects' static two point discrimination threshold in their finger pads, palm, and dorsum of the hand, in the operative and non-operative extremity, each measured in millimeters.
Average Grip Strength (lbs) in the operative hand and non-operative hand
时间窗: up to 6 months
Subjects' grip strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied by the hand to a Jamar Dynometer in pounds.
Aggregated Brief Michigan Hand Questionnaire results (composite score)
时间窗: up to 6 months
Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100.
次要结局
- Number of patients with complete flap loss(up to 6 months)
- Number of patients with partial flap loss(up to 6 months)
- Number of patients reporting cold intolerance(up to 6 months)
- Number of patients with partial skin graft non-take(up to 6 months)
- Number of patients experiencing mortality(up to 6 months)
- Number of patients with postoperative hematoma at donor site(up to 6 months)
- Number of patients with donor site dehiscence(up to 6 months)
- Number of patients with complete skin graft non-take(up to 6 months)
- Number of patients with postoperative hematoma at recipient site(up to 6 months)
- Number of patient with postoperative infection at recipient site(up to 6 months)
- Number of patients reporting neuropathy(up to 6 months)
- Number of patients with postoperative cellulitis at donor site(up to 6 months)
研究者
Joshua Adkinson
Chief of Hand Surgery
Indiana University