Trial document





This trial has been registered retrospectively.
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  DRKS00004408

Trial Description

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Title

WOUND COMPLICATIONS AFTER MEDIAN STERNOTOMY

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Sternal wound complications following median sternotomy remain a challenge in cardiac surgery. Changes in both the patient profiles and the types of operations have been observed in the recent years. Therefore, we want to analyze the actual wound healing complications after median sternotomy at our center.
All adult patients with median sternotomy between January 2009 and April 2011 are to be included in this retrospective analysis. Transplantations and assist devices implantations are omitted. We will assess outcome, microbiologic results of standardized wound swabs, and prognostic factors.

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Brief Summary in Scientific Language

Sternal wound complications following median sternotomy remain a challenge in cardiac surgery. Changes in both the patient profiles and the types of operations have been observed in the recent years. Therefore, we want to analyze the actual wound healing complications after median sternotomy at our center.
All adult patients with median sternotomy between January 2009 and April 2011 are to be included in this retrospective analysis. Transplantations and assist devices implantations are omitted. We will assess outcome, microbiologic results of standardized wound swabs, and prognostic factors.

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Organizational Data

  •   DRKS00004408
  •   2012/10/15
  •   [---]*
  •   yes
  •   Approved
  •   382/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1135-8421 
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Health Condition or Problem studied

  •   Wound complications after median sternotomy
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Interventions/Observational Groups

  •   adult patients with median sternotomy (excluding ventricular assist device implantation and heart transplantation), follow-up in hospital, analysis of mortality, wound complications, microbial wound swabs and perioperative risk factors
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

wound healing complication in hospital

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Secondary Outcome

results of wound swabs, risk factors (multivariate analysis)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/01/01
  •   1300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   120   Years
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Additional Inclusion Criteria

median sternotomy

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Exclusion Criteria

heart transplantion, implantation of ventricular assist devices

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Addresses

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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Abt. Herz- und Gefäßchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Abt. Herz- und Gefäßchirurgie
    • Ms.  Dr.  Claudia  Heilmann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Ms.  Dr.  Claudia  Heilmann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Abt. Herz- und Gefäßchirurgie
    • Ms. 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/04/30
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Trial Publications, Results and other Documents

  •   Interactive CardioVascular and Thoracic Surgery (2013) doi:10.1093/icvts/ivs554
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* This entry means the parameter is not applicable or has not been set.