Hyperbaric Oxygen Therapy Clinical Trial
Official title:
Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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