Trial document




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  DRKS00003244

Trial Description

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Title

Use of GentaColl after median sternotomy

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Trial Acronym

EIGEMS

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URL of the Trial

http://-

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Brief Summary in Lay Language

After median sternotomy during cardiac surgery up to 29% of patients develop surgical site infections. Clinical outcome of this is assotiated with prolongated hospital and ICU treatment as well as an increased risk of in-hospital death.
Thus, we investigate wether use of the genatmycin rich collagen sponge GentaColl (Resorba) is a usefull tool to reduce the incidence of mediastinitis and SSI.

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Brief Summary in Scientific Language

Surgical site infections (SSI) after median sternotomy represent a serious complication and a high potential risk for adverse clinical outcome after cardiac surgery.
The reported incidence of postoperative SSI after sternotomy in cardiac surgery varies from 0.25 to 29% with an associated mortality between 10 and 29% (Lepelletier et al. 2005).
Thus, we investigate wether the application of a gentamycin contending collagen sponge can reduce the incidence of postoperative mediastinitis and SSI. Secoundary endpoints are the duration of ICU and in-hosüpital stay.

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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

  •   DRKS00003244
  •   2011/08/31
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  •   yes
  •   Approved
  •   EK 148042011, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   J98.50 -  [generalization J98.5: Diseases of mediastinum, not elsewhere classified]
  •   T81.8 -  Other complications of procedures, not elsewhere classified
  •   T81.4 -  Infection following a procedure, not elsewhere classified
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Interventions/Observational Groups

  •   Intervention group: Use of GentaColl, a gentamycin rich collagen sponge (Resorba) during closure of sternotomy,
    (to day: routinely used during closure of sternotomy)
  •   historical cohort operated before introduction of GentaColl in routine-use of closure of sternotomy
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Prevention
  •   Other
  •   N/A
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Primary Outcome

primary outcome: The use of GentaColl reduces the incidence of mediastinitis inbetween the 30 day follow-up after cardiac surgery with median sternotomy.
The classification of surgical site infections is published by Horan et al (1992), the so called CDC classification.

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Secondary Outcome

hospital stay, ICU-stay, death, mild forms of surgical site infection, delir

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/09/18
  •   600
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

elecriv cardiac surgery with median sternotomy

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Exclusion Criteria

urgency cardiac surgery, transplatation, endocarditis

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Addresses

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    • Herzzentrum Dresden Universitätsklinik, Klinik für Herzchirurgie
    • Fetscherstr. 76
    • 01307   Dresden
    • Germany
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    • Herzzentrum Dresden Universitätsklinik, Klinik für Herzchirurgie
    • Mr.  PD Dr. med.  Thomas   Waldow 
    • Fetscherstr. 76
    • 01307   Dresden
    • Germany
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    • Herzzentrum Dresden Universitätsklinik, Klinik für Herzchirurgie
    • Ms.  Dr.  Katrin  Plötze 
    • Fetscherstr. 76
    • 01307   Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Resorba Wundversorgung GmbH&Co.KG
    • A.  Flierl 
    • Am Flachmoor 16
    • 90475  Nürnberg
    • Germany
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    • Herzzentrum Dresden Universitätsklinik, Klinik für Herzchirurgie
    • Fetscherstr. 76
    • 01307   Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.