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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Universal Hospital of the RWTH Aachen University
Aachen, North Rhine-Westphalia, Germany
Start Date
December 1, 2010
Primary Completion Date
November 1, 2012
Completion Date
November 1, 2012
Last Updated
November 27, 2012
20
ACTUAL participants
Stitches
PROCEDURE
Fibrin-glue
PROCEDURE
Stitches and Fibrin-glue
PROCEDURE
Lead Sponsor
RWTH Aachen University
NCT06723639
NCT06799832
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT03259204