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临床试验/NCT01365780
NCT01365780暂停不适用

Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)

RWTH Aachen University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
100
试验地点
2
主要终点
functional outcome

研究概览

简要总结

This project is meant to show wether the HBOT can fasten the recovery process after surgical treatment of distal Radius fractures. For this propose the microcirculation is measured, together with the level of pain on a visual analog scale (VAS) and the remaining force of the hand after surgery is examined. Furthermore the sonography with contrast medium which is long established for examination of organs of the parenchyma, is meant to be verified at the muscular-skeletal system in this project.

详细描述

This project investigates microcirculation in skin, muscle and bone after surgical treatment of distal Radius fracture with and without Hyperbaric Oxygen Therapy for detecting any benefit of the HBOT. In Hyperbaric Oxygen Therapy the patients breathes Oxygen from a mask in a pressure chamber with higher air pressure than normal atmospheric pressure wich is meant to increase the peripheric oxygen suppley in the healing tissue. The patients will receive 10 sessions of HBOT. The patients who are treated with HBOT are chosen randomly.

The microcirculation is measured as parameter for tissue damage and wound healing. It 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 8 measurements in this study:

The first one shortly after the surgical treatment, then there will be one measuring appointment every week up to four week. Afterwards the patients hands will be measured in the 6th, 8th and 12th week after surgical treatment. In all measurements the healthy side will be measured as well for comparison. Additional the force fo both hands and the level of pain in the Visual Analogue Scale are evaluated.

Furthermore there will be a sonography with contrast medium in the first week after surgical treatment to indicate any increase of blood suppley after the HBOT and detect any wound healing complications.

Therefore this study will research on the one hand if there is a benefit to the HBOT for the often young and healthy patients of radius fractures to return earlier and more easily to their health condition. On the other hand this study is meant to establish the sonography with contrast medium as a examination method with little risks.

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

  • distal radius fracture
  • only one radius is fractured
  • medical treatment within 72 hours after accident
  • patient will receive surgical treatment (plate)
  • patient received information letter and singed agreement
  • patient is German-speaking
  • patient is competent
  • patient is over 18 years of age

排除标准

  • pathologic fractures
  • open fractures
  • fractures with wide soft tissue damage, that affects surgical treatment
  • surgical treatment after more than 72 hours after the accident
  • diabetes mellitus, that need medical treatment
  • patient has PAD
  • previous surgery treatment on the fractured arm or refracture
  • patient is not competent
  • immune deficiency
  • polytrauma
  • patient with diseases of the lung (hypercapnia)
  • patient with open Foramen ovale
  • pregnant women
  • patient with NYHA IV

结局指标

主要结局

functional outcome

时间窗: 18 months

The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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