Trial document





This trial has been registered retrospectively.
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  DRKS00006239

Trial Description

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Title

Subcutaneous application of gentamicin collagen implants as prophylaxis of surgical site infections in laparoscopic colorectal surgery: A randomized, double-blinded, 3-armed trial

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Despite prophylaxis with antibiotics wound infections occur regularly in surgery of the colon . There is evidence that the application of antibiotic-containing sponges in the wound can reduce this rate. However, reliable data does not exist. Therefore, this study is conducted. Sponges containing collagen or gentamycin and collagen are used randomly.

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Brief Summary in Scientific Language

Despite a standardized prophylaxis with antibiotics surgical site infections (SSI) are a characteristic problem in colorectal surgery. Local administration of gentamicin-collagen sponges (GCS) has shown to decrease the infection rate after contaminated procedures. So far the effect has not been tested for standardized laparoscopic colorectal resections.
This randomized, double-blind, placebo-controlled trial aims to investigate the efficacy of GCS to reduce wound infection after laparoscopic colorectal resections. The intervention was application of a GCS, a collagen-sponge or no sponge in the subcutaneous tissue of the bowel extraction site. Primary endpoint was surgical site infection after definition of CDC.

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Organizational Data

  •   DRKS00006239
  •   2014/06/12
  •   [---]*
  •   yes
  •   Approved
  •   2008-054-F, 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

  •   Subcutaneous application of a gentamicin collagen sponge (GCS) (Gentacoll resorb®, Resorba Medical GmbH, Nürnberg, Germany) of 6,25 cm2 containing 17,5 mg equine collagen and 12,5 mg gentamicinsulfat
  •   Subcutaneous application of a sponge (Kollagen resorb®, Resorba Medical GmbH, Nürnberg, Germany) of 6,25 cm2 containing 17,5 mg equine collagen
  •   No subcutaneous Sponge
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo, Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Surgical Site Infection (according definition of CDC) in the first 28 days after surgery, visite by investigator

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Secondary Outcome

incidence of surgical or general complications, the length of hospitalization and the incidence of incisional hernias during study period, check of patient file

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2008/07/01
  •   297
  •   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

All adult patients scheduled for an elective laparoscopic resection

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Exclusion Criteria

known allergic reaction to gentamicin or animal collagen, refusal to participate, expected incompliance or intraoperative conversion to open surgery

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Addresses

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    • Marienhospital 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
  •   2012/01/07
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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.