Trial document



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  DRKS00000390

Trial Description

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Title

Prevention of abdominal wound infection:
PROUD-Trial
A randomized controlled trial

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Trial Acronym

PROUD-Trial

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URL of the Trial

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Brief Summary in Lay Language

Wound infection remain one of the most important comlications after abdominal surgery.
This is an interventional trial to investigate the rates of wound infection within 30 days after midline incision for abdominal surgery using two different materials for abdominal closure:
1. continuous closure using a slowly absorbable material, wich is coated with Triclosan (IRGACARE® MP).
2. continuous closure using a slowly absorbable material, wich is not coated.
Patients with elective midline laparotomy for any reason (except for emergency surgery).
Rates of wound infection are assumes to be the same in both groups.

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Brief Summary in Scientific Language

To evaluate possible differences in the frequency of wound infections and wound dehiscence within one month after index operation using two different suture materials (PDS vs. PDS+) for continuous abdominal fascial closure after elective midline laparatomy.

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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

  •   DRKS00000390
  •   2010/04/27
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  •   yes
  •   Approved
  •   S-064/2010, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1114-6522 
  •   01/2010  (KSC Trial Number)
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Health Condition or Problem studied

  •   elective midline laparotomy
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Interventions/Observational Groups

  •   The abdomen will be closed by a continuous, all-layer suture using two loops of slowly absorbable monofilament suture =PDS II plus (coated with triclosan).
  •   The abdomen will be closed by a continuous, all-layer suture using two loops of slowly absorbable monofilament suture =PDS II
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Characteristics

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

Wound infection (deep and superficial according to CDC definition) within 30 days after surgery

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Secondary Outcome

Duration of surgery /
Length of incision /
Frequency of wound dehiscence (with or without evisceration) /
Frequency of re-operation due to wound dehiscence /
Postoperative intensive care unit stay /
Postoperative hospital stay /
30 day mortality /
Quality of life (QoL)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/04/07
  •   1200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

age >= 18 years/

Patients undergoing elective midline laparatomy /

Informed consent

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Exclusion Criteria

Participation in another intervention-trial with interference of intervention and / or outcome of this study /

Impaired mental state or language problems

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Addresses

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    • Universitätsklinik Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Chirurgische Universitätsklinik Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC
    • Ms.  Colette  Dörr-Harim 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Chirurgische Universitätsklinik Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC
    • Ms.  Colette   Dörr-Harim 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • ETHICON UK, a division of JOHNSON & JOHNSON MEDICAL LIMITED Kirkton Campus Scotland
    • P.O. Box 1988
    • EH54 0AB  Livingston EH54 0AB
    • United Kingdom
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/18
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Trial Publications, Results and other Documents

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