Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).
研究概览
简要总结
Our study aims to prospectively compare outcomes of conservative treatment (occlusive dressing) to surgery with a palmar bipedicled island flap (modified Tranquilli-Leali flap) in the management of Allen zones II-III-IV fingertip injuries in long fingers. Based on these results, the investigators intend to help provide guidelines to optimize the management, and eventually the satisfaction of these patients.
详细描述
The investigators intend to conduct a prospective tricentric (Hand Surgery Service in CHUV( Centre Hospitalier Universitaire Vaudois, Lausanne/ Hand Surgery Service in HUG (Hôpitaux Universitaire de Genève and Hand Surgery Service in Valais hospital, Sierre), open-label, randomized controlled trial: Occlusive dressing versus surgery in fingertips amputation.
The investigators will collect demographic data and informations about the injury including age, sex, medical history and daily medications, occupation, dominant hand, active smoking, mechanism of injury, associated injuries, time from injury to management, size and geometry (volar/transverse/dorsal) of defect, level of amputation (Allen classification), injury and repair of the nail bed.
Patients will be randomized into the occlusive dressing group or the surgical group on their first visit to the Hand Surgery department.
Both groups will have 6 months and 1-year follow-up appointment, including Ultrasound evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients > 18 years old
- •Allen zones II-III-IV long finger amputation.
- •Trauma < 48h.
排除标准
- •Patients who are not able to give consent
- •Injuries involving the DIP joint, extensor apparatus or requiring osteosynthesis.
- •Chronic dermatological disorders of the hand, immunosuppressive drugs or chemotherapy. - Patient without a consent form would be excluded.
结局指标
主要结局
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).
时间窗: Enrollment in the study for one year
Patients will be instructed to rate their satisfaction (according to different criteria: overall hand function, activities of daily living, work performance, pain, and cosmetic) by checking on a horizontal line their degree of satisfaction. After evaluation, their measurement was considered as a continuous measure (0-100 mm). Higher scores indicate better satisfaction.
次要结局
- Objective evaluation of fingertips(Enrollment in the study for one year)