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临床试验/NCT02096562
NCT02096562已完成不适用

Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery

University of Rostock2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Amount of Swelling of lower Extremity (circumference in mm and volume in ml)

研究概览

简要总结

Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with compression stockings.

The investigators are going to investigate the effect of compression stockings on postsurgical swelling and formation of edema on outpatients.

详细描述

The investigators are planing on investigate the effect of compression stockings on postsurgical swelling and formation of edema. For this purpose the investigators devide outpatients who have undergone knee surgery to two different clinical study groups. Group A receives a common compression bandage after surgery to the first postsurgical day and receives compression stockings afterwards for the following 10 days, while Group B only receives a common compression bandage to the first postsurgical day. Group A will be instructed to wear compression stockings for 24 hours on the first two postsurgical day, afterwards at least for 8 hours a day.

Preoperatively the investigators are going to determine the volume and circumference of both legs using the Bodytronic 600 by Bauerfeind. Subsequently the measurement will be repeated on the first, forth and tenth postsurgical day. The investigators are going to measure the range of motion, also the patients of both groups will be asked to mark pain and tension on a visual analog scale and write down the amount of time they have been lying, sitting and standing each day. Group A will document the amount of time for how long they were wearing compression stockings each day.

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
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

入选标准

  • age > 18 years
  • signed release form

排除标准

  • deep vein thrombosis
  • swelling caused by cardiac, venous or endocrine genesis
  • dysfunction of the lymphatic system
  • dysfunction of kidney or liver
  • Use of water withholding medication
  • massive adiposity

结局指标

主要结局

Amount of Swelling of lower Extremity (circumference in mm and volume in ml)

时间窗: 10 days

次要结局

  • Pain (visual analoge scale) and Range of Movement (degree of flexion)(10 days)

研究者

发起方
University of Rostock
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Oye

University of Rostock

University of Rostock

研究点 (2)

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