Trial document



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  DRKS00006199

Trial Description

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Title

Postoperative negative pressure incision therapy following open colorectal surgery: a randomized-controlled trial

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Trial Acronym

Poniy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

More than 20% of patients develop surgical site infections following colorectal surgery, which cause substantial morbidity, prolongation of hospital stay, costs and even mortality. A novel negative pressure incision therapy device, which is applied for 5-7 days postoperative, was developed to reduce surgical site infections by continuous removal of wound secretion from the incisional wound. However, the device has not yet been tested in a high-quality trial and its effectiveness is therefore unclear. The Poniy trial will investigate, whether this negative pressure incision therapy device reduces wound infections in comparison to standard wound coverage in patients undergoing open elective colorectal surgery.

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Brief Summary in Scientific Language

The aim of the trial is to investigate whether negative pressure incisional therapy for 5-7 days postoperative significantly reduces postoperative surgical site infections in comparison to standard wound dressings following open elective abdominal surgery.

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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

  •   DRKS00006199
  •   2014/08/20
  •   [---]*
  •   yes
  •   Approved
  •   155/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   open colorectal surgery
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Interventions/Observational Groups

  •   Postoperative wound coverage with negative pressure incisional therapy device (PrevenaTM Incision Management System) for 5-7 days postoperative.
  •   Postoperative wound coverage with standard dressings for 5-7 days postoperative.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of surgical site infections according to the definition of the Centers for Disease Control and Prevention within 30 days postoperative.

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Secondary Outcome

1.) Length of hospital stay
2.) Rate of reoperations
3.) Rate of antibiotic theray
4.) Duration of postoperative negative pressure incision therapy (intervention arm only)
5.) Wound pain assessed with visual analogue scale
6.) Rate of wound complications other than wound infections
7.) Rate of serious adverse events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/10/01
  •   340
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1.) Planned elective open colorectal surgery via median or transverse laparotomy
2.) Age 18 years or older
3.) Ability to understand the nature and extend of the trial and to sign the written informed consent.

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Exclusion Criteria

1.) Pregnancy or breast-feeding
2.) Median or transverse laparotomy within the last 60 days prior to inclusion into the study.
3.) Planned relaparotomy within 30 days
4.) Laparoscopic or laparoscopic assissted surgery
5.) Patients on preoperative antibiotic treatment

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Addresses

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    • Klinikum rechts der Isar,Technische Universität München
    • Mr.  Dr.med. M.Sc.  Andre L.  Mihaljevic 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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    • Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
    • Ms.  Dr.med.   Rebekka  Schirren 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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    • Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
    • Ms.  Dr.med.  Rebekka  Schirren 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • KCI Europe
    • Mr.  Dr.  Christian L.  Seelandt 
    • Hagenauer Straße 47
    • 65203  Wiesbaden
    • 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.