Trial document




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  DRKS00000697

Trial Description

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Title

COSTA - Closure of median sternotomy in high-risk patients with the sternal talon system

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Trial Acronym

COSTA

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URL of the Trial

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Brief Summary in Lay Language

Currently, a median sternotomy is closed by wires. A new system for sternal closure, the Sternal Talon®, has been developed. It consists of two parts which enclose the breast bone claw-like and are closed by a ratchet mechanism. This leads to a stable connection of the bone which prevents inflammation and disturbed healing. The study compares the new device with conventional wiring.

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Brief Summary in Scientific Language

Disturbed healing and inflammation after median sternotomy are significantly more frequent complications in high-risk patients. The study compares the conventional wiring technique with the Sternal Talon, a new device for sternal closure in these patients. First clinical observations show a reduced rate of complications with the Sternal Talon with good tolerance and lower postoperative pain.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000697
  •   2011/01/19
  •   2008/07/14
  •   no
  •   Approved
  •   188/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001686  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   mediastinitis after median sternotomy
  •   J98.50 -  [generalization J98.5: Diseases of mediastinum, not elsewhere classified]
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Interventions/Observational Groups

  •   Closure of median sternotomy by Sternal Talon
  •   closure of median sternotomy by wires
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

Incidence of mediastinitis or sternal instability within the first 30 (+/- 5) days after primary sternal closure

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Secondary Outcome

1. Intensity of postoperative pain in the chest area on the first and third postoperative days during the hospitalization period, and on the 7th, 14th, 21st and 30th day in case of continued hospitalization.
2. Incidence of mediastinitis or sternal instability within the first 60 (+/- 5) days after primary sternal closure.
3. Incidence of a transverse sternal fracture during the first 30 (+/- 5) days after primary sternal closure.
4. Incidence of pneumonia during the hospitalization period up to a maximum of 30 days after primary sternal closure

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2008/12/01
  •   250
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- planned median sternotomy
- at least 18 years old
- at least 4 of the following risk factors:
age at least 65 years
age at least 80 years
myocardial infarction within the last 90 days and left-ventricular ejection fraction at or below 35%
peripheral arterial disease
chronic obstructive pulmonary disease
creatinine at or above 200 µmol
immunosuppression, cytostatics
critical general condition
planned utilization of both Aa. mammariae
body mass index at or above 30 kg/m²
body mass index at or above 40 kg/m²

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Exclusion Criteria

- hyperresponsiveness to titanium
- systemic antibiotic therapy
- thoracic anomaly
- pregnancy possible, breast-feeding
- lacking compliance

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Addresses

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    • Gebrüder Martin GmbH & Co. KG
    • Ludwigstaler Straße 132
    • 78532  Tuttlingen
    • Germany
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    • Universitätsklinikum Freiburg Chirurgie - Herz - und Gefäßchirurgie
    • Mr.  Dr. med.  Stefan  Sorg 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Allgemeines Krankenhaus der Stadt Wien Universitätsklinik für Chirurgie Abteilung für Herz-Thoraxchirurgie
    • Ms.  Dr. med.  Tatjana  Fleck 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • Universitätsklinikum Freiburg Abt. Herz- und Gefäßchirurgie
    • Mr.  Dr.  Stefan  Sorg 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Gebrüder Martin GmbH & Co. KG
    • Ludwigstaler Straße 132
    • 78532  Tuttlingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/05/02
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Trial Publications, Results and other Documents

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