Trial document




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  DRKS00020933

Trial Description

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Title

Does the application of adhesive skin drapes reduce the risk of early wound infection after implantation of central-venous port systems? A randomized trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In onkology, central-venous ports systems are implanted into the body, in order to make repeated administration of chemotherapeutic drugs and nutrition easier. Implantation of a port systems carries a low risk of infection. Some hospitals cover the patient's skin with adhesive drapes before start of surgery, because this might protect the wound from skin bacteria. The current study will assess which advantages or disadvantages such skin drapes have.

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Brief Summary in Scientific Language

This randomized controlled trial assesses whether additional application of adhesive skin drapes before surgical implantation of central-venous port systems has an effect on surgical site infection.

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

Yes

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Description IPD sharing plan:

After study closure, individividual patient data in an anonymous format will be made available on reasonable request.

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Organizational Data

  •   DRKS00020933
  •   2020/02/21
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  •   yes
  •   Approved
  •   44/2019, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C75 -  Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
  •   OPS-2020: 5-399.5
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Interventions/Observational Groups

  •   After antiseptic skin preparation in the OR the skin in the operating field (upper thorax and lower neck) will be covered with an adhesive skin drape. Implantation of the port system at jugular or cephalic vein will be performed through a small skin incision. At the end of surgery, the skin drapes will be carefully removed. The wound is closed by subcutaneous sutures (Vicryl 3.0) and skin sutures (Ethilon 3.0).
  •   In the OR, antiseptic skin preparation in the operating field (upper thorax and lower neck) is done in the usual way. Implantation of the port system at jugular or cephalic vein will be performed through a small skin incision. At the end of surgery, the wound is closed by subcutaneous sutures (Vicryl 3.0) and skin sutures (Ethilon 3.0).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Surgical site infection (defined according to the criteria of CDC [Centers of Disease Control]) within 4 weeks

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Secondary Outcome

Duration of surgery; severe adverse events; pain (measured with the numerical rating scale); length of hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/03/01
  •   100
  •   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

Indication for elective implantation of a central-venous port system

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Exclusion Criteria

Therapy-related immunosuppression; septic focus; pregnancy; lack of written informed consent

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Addresses

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    • Klinik für Allgemein- und Viszeralchirurgie, Evangelisches Krankenhaus Lippstadt gemeinnützige GmbH
    • Mr.  Prof. Dr.med.  Mike Ralf  Langenbach 
    • Wiedenbrücker Straße 33
    • 59555  Lippstadt
    • Germany
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    • c/o Institut für Gesundheitsökonomie und Klinische Epidemiologie (IGKE) der Universität zu Köln
    • Mr.  Prof. Dr.med.  Stefan  Sauerland 
    • Gleueler Str. 176-178
    • 50935  Köln
    • Germany
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    • Klinik für Allgemein- und Viszeralchirurgie, Evangelisches Krankenhaus Lippstadt gemeinnützige GmbH
    • Mr.  Sönke  Scheunemann 
    • Wiedenbrücker Straße 33
    • 59555  Lippstadt
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein- und Viszeralchirurgie, Evangelisches Krankenhaus Lippstadt gemeinnützige GmbH
    • Mr.  Prof. Dr.med.  Mike Ralf  Langenbach 
    • Wiedenbrücker Straße 33
    • 59555  Lippstadt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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