An interventional study of Hyperbaric Oxygen Therapy in Hyperbaric Oxygen Therapy, Recovery Time and Contrast Media, sponsored by RWTH Aachen University. Suspended at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-28.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Treatment
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.
272 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 218 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients, who receive hyperbaric Oxygen Therapy after their surgical treatment
Procedure: Hyperbaric Oxygen Therapy
Patients who receive the same surgical treatment of their radius fracture than the patients of the group "with HBOT", but no hyperbaric oxygen therapy (comparison group)
The patients receive 10 sessions of HBOT in two weeks, starting on the day after the surgical treatment of their radius fracture. Each session lasts about one hour.
functional outcome
The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.
Time frame: 18 months
This study is suspended, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University