Microcirculation Clinical Trial
Official title:
Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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