Effective Treatment of Posttraumatic and Postoperative Edema in Patients With Ankle- and Hindfoot Fractures. A Randomized Controlled Trial Comparing Multi-layer Compression Therapy and A-V Impulse Compression to the Standard Treatment With Ice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Ankle edema as measured with the figure-of-eight20 method
研究概览
简要总结
Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.
详细描述
After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Inpatients
- •Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
- •No walking aids before trauma
- •Written informed consent
- •Monotrauma
- •Preoperative and/or postoperative edema
- •Preoperative inclusion
- •if delay of surgery due to ankle edema
- •if fracture stable enough for temporary removal of orthesis
排除标准
- •Diabetes Mellitus
- •Lymphedema
- •Peripheral arterial occlusive disease (PAD)
- •Decompensated heart failure or renal insufficiency
- •Acute bacterial infection
- •Severe osteoporosis
- •Pathological fractures
- •Known tumors
- •Postthrombotic syndrome
- •Thrombosis
- •Open fractures
- •Polytrauma, cerebral trauma
- •Neurological deficiencies
- •Diuretics
- •Pregnancy
- •Alcohol or drug abuse
- •Psychological disorders
研究组 & 干预措施
Control group
The Control group received ice gel packs and elevation to reduce edema.
干预措施: ice gel pack (Behavioral)
Multi-layer compression bandage
A multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated.
干预措施: Multi-layer compression bandage (Other)
A-V Impulse compression
An A-V Impulse compression device was used to reduce edema.
干预措施: A-V Impulse compression (Device)
结局指标
主要结局
Ankle edema as measured with the figure-of-eight20 method
时间窗: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint.
次要结局
- Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale(12 weeks and 1 year postoperative.)
- Number of complains of discomfort or intolerances considering the intervention(Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.)
- Patient satisfaction with treatment scores measured on the Visual Analogue Scale(Participants were assessed for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative --> assessment at the day of discharge.)
- Number of postoperative hospitalization days(Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.)
- Amount of daily intake of medication(Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.)
- Number of adverse events as a measure of safety in each group(Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Patient file was screened for adverse events until 1 year postoperatively.)
- Amount of volumetric lower limb edema(Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.)
- Pain scores measured on the Visual Analogue Scale (VAS)(Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-ups at 6 weeks, 12 weeks and 1 year postoperative.)
- Number of days until possible operation(Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.)
- Range of motion of the ankle joint and foot.(Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.)
- Lower limb function (Foot and ankle ability measure)(12 weeks postoperative, 1 year postoperative.)
- General Health (SF-36)(12 weeks postoperative,1 year postoperative.)
研究者
Reto Babst
Prof. Dr. med. Reto Babst, Senior Consultant Orthopedic Trauma
Luzerner Kantonsspital