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PDS*Plus and Wound Infections After Laparotomy (PDS*plus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998907
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Christoph Justinger, University Hospital, Saarland

Brief Summary:
The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin suture.

Condition or disease Intervention/treatment Phase
Wound Infection Incisional Hernia Device: PDS plus Device: PDS II Not Applicable

Detailed Description:

All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.

Wound closure is achieved using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge. In the first time period , the CP step for fascia closure foresees a triclosan-coated PDS 910 loop suture (PDS plus®, Ethicon GmbH, Norderstedt, Germany). In the second time period the CP step will be altered to the use of PDS loop suture (PDS II®, Ethicon GmbH, Norderstedt, Germany). The CP- step is changed every 100 patients to cluster-randomize the patients. The primary outcome is the number of wound infections. Together with this the number of incisional hernia will be recorded. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1042 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures
Study Start Date : September 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: PDS II
PDS II® loop suture is used for abdominal wall closure
Device: PDS II
polyglactin 910 suture material for abdominal wall closure

Experimental: PDS plus
antibacterial coated "PDS plus" is used for abdominal wall closure
Device: PDS plus
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
Other Name: PDS plus®

Primary Outcome Measures :
  1. The number of wound infections [ Time Frame: 30 days after the operation ]

Secondary Outcome Measures :
  1. The number of incisional hernias. [ Time Frame: 6 month ]
  2. The number of incisional hernia- long time follow up [ Time Frame: 12 month ]
    number of incisional hernia after 24 month

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • surgical pathologies accessed via midline or transverse abdominal incision
  • primary fascial closure

Exclusion Criteria:

  • pregnancy
  • age under 18 years
  • open abdominal treatment
  • known hypersensitivity against PDS/Triclosan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998907

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Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,
Homburg/Saar, Germany, D-66421
Sponsors and Collaborators
University Hospital, Saarland
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Principal Investigator: Christoph Justinger, M.D. Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Study Director: Martin K Schilling, M.D., FRCS Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christoph Justinger, Priciple Investigator, University Hospital, Saarland Identifier: NCT00998907    
Other Study ID Numbers: 09/2009
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Christoph Justinger, University Hospital, Saarland:
Open Abdominal Surgery
Fascial Closure
Additional relevant MeSH terms:
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Communicable Diseases
Wound Infection
Incisional Hernia
Wounds and Injuries
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes