Randomized and Controlled Prospective Study on Use of the Adhesive Elastic Tape to Control Hand Edema in Patients With a Wrist Fracture Treated With Forearm Plaster.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Thumb Circumference
研究概览
简要总结
Wrist fractures are a very common event affecting patients of all ages and are estimated to account for approximately 10% -25% of all fractures. 70-90% of fractures are treated with closed reduction and forearm cast. In 2019, 17.4% of wrist fractured patients treated with a plaster cast at the Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza had a second access to the OED for edema, pain or "intolerance to the plaster cast ".
In literature, there are several studies that demonstrate the effectiveness of adhesive elastic tape for edema control, mostly lymphedema secondary to breast cancer or post-operative edema after knee arthroplasty, although a definitive evidence is still needed.
With this trial, the investigators aim to evaluate the tape effectiveness in counteracting hand edema formation in wrist fractured adult patients treated with forearm cast.
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
Data processing will be blinded
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
- •Patients with growth plates closed on radiographic examination
- •Unilateral distal radius fracture associated or not with ulnar styloid fracture
- •Wrist fracture requiring bloodless reduction and immobilization with a forearm cast
排除标准
- •Patients with multiple fractures
- •Polytrauma patients
- •Patients with previous plegia / paralysis of the fractured limb
- •Patients with previous lymphedema of the fractured limb
- •Patients with access to the OED during the night when the organization does not guarantee the presence of 2 nurses
- •Wounds or abrasions in the area of application of the tape
- •Acute thrombosis (upper limb veins)
- •Scars not perfectly healed in the area of application of the tape
- •Dermatitis, psoriatic manifestations or erythema in the area of application of the tape
- •Known allergy to acrylic (patch glue)
- •Solid neoplasms
结局指标
主要结局
Thumb Circumference
时间窗: baseline and 1 week
thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Circumference of the Other 4 Fingers All Together
时间窗: baseline and 1 week
difference between T0 and T1 in the circumference of the other 4 fingers (index, middle, ring and pinky) all side by side, measured at the first phalanx
次要结局
- Number of Participants With OED Entry(1 week)
- Pain Degree by Numerical Rating Scale (NRS)(1 week)
- Number of Participants Taking Painkillers(1 week)
研究者
Massimo Guasconi
RN, MSN
Azienda Unita Sanitaria Locale di Piacenza