Trial document




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  DRKS00008830

Trial Description

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Title

Surgical site infections at sonographically proven subcutaneous fluid collections

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Trial Acronym

WISO

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URL of the Trial

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Brief Summary in Lay Language

After surgical procedures via abdominal incision fluid collections in the subcutaneous fatty tissueoccasionally occur. This study attempts to clarify the influence of such fluid collections at the formation of wound complications. Ultrasonography of the subcutaneous tissue is performed in the postoperative days and the incidence of wound complications determined in patients with or without fluid collections.

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Brief Summary in Scientific Language

After laparotomy the formation of seroma in the subcutaneous tissue occur sometimes. This study tries to find out the influence of such seromas on the formation of surgical site infections and wound complications. Ultrasonography of the subcutaneous tissue is performed in the postoperative days and the incidence of wound complications determined in patients with or without fluid collections

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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

  •   DRKS00008830
  •   2015/07/24
  •   [---]*
  •   yes
  •   Approved
  •   F-2015-041, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   T81.4 -  Infection following a procedure, not elsewhere classified
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Interventions/Observational Groups

  •   Patients with postoperative subcutaneous seroma, determined during ultrasound examinations on postoperative day 1, 2 and 4
  •   Patients without postoperative subcutaneous seroma during ultrasound examinations on postoperative day 1, 2 and 4
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incidence of surgical site ocurrences or surgical site infections (CDC-classification) within 30 days

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Secondary Outcome

Length of hospital stay, complications (dindo-clavien classification) within 30 days, pain (VAS-score) on postoperative day 1, 2 and 4.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/08/01
  •   57
  •   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

Laparotomy due to abdominal surgery

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Exclusion Criteria

Refusal to participate

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Addresses

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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Mr.  Dr.  Julius  Pochhammer 
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Mr.  Dr.  Julius  Pochhammer 
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/03/16
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Trial Publications, Results and other Documents

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