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临床试验/NCT01265004
NCT01265004已完成不适用

Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Microcirculation

研究概览

简要总结

This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.

详细描述

This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.

Every method is long established and can be treated as clinical equal. So the surgical treatment is chosen randomly for each patient.

For this cause the microcirculation is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are nine measurements on this study: one before and one shortly after the surgery, followed by three measuring appointment every 6 hours (6,12,18,24 h post-op).Afterwards there are appointments planed after 12 days and 6 month. On the last appointment the patients are questioned according to established scores like AOFAS or VAS to register the functional outcome and level of pain.

Clinical parameters like time between rupture and surgical treatment, hospitalisation time, and form of anaesthesia are included to create comparable patient profiles. After 6 moths the last measurement appointment is stated, in which the clinical outcome is registered by Scores, e.g Mann-Whitney-Wilcoxon-Test.

This study is to detect any difference in wound heeling, re-rupture rate and functionality between these three methods.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Acute rupture of the achilles tendon (on one or both sides)
  • Older than 18 year of age
  • Firmed letter of approval
  • Patient speaks/understands German
  • Planed surgical treatment
  • No more than 48h after rupture

排除标准

  • No-traumatic rupture of the achilles tendon
  • More than 48h after rupture
  • No planed surgical treatment
  • History of surgery on the injured leg
  • Condition of diabetes mellitus
  • Condition of peripheral artery occlusive disease

结局指标

主要结局

Microcirculation

时间窗: 6 month

The microcirculation is measured by O2c, an non-invalive device functioning with lightwaves. Based on this data the soft tissue damage, edema and healing process is protocoled.

次要结局

  • Functional outcome(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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