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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Justinger, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00998907
First received: October 20, 2009
Last updated: January 17, 2012
Last verified: January 2012

October 20, 2009
January 17, 2012
September 2009
November 2011   (final data collection date for primary outcome measure)
The number of wound infections [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998907 on ClinicalTrials.gov Archive Site
  • The number of incisional hernias. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • The number of incisional hernia- long time follow up [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    number of incisional hernia after 24 month
The number of incisional hernias. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
PDS*Plus and Wound Infections After Laparotomy
Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Wound Infection
  • Incisional Hernia
  • Device: PDS plus
    triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
    Other Name: PDS plus®
  • Device: PDS II
    polyglactin 910 suture material for abdominal wall closure
    Other Name: PDS II
  • Active Comparator: PDS II
    PDS II® loop suture is used for abdominal wall closure
    Intervention: Device: PDS II
  • Experimental: PDS plus
    antibacterial coated "PDS plus" is used for abdominal wall closure
    Intervention: Device: PDS plus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1042
January 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00998907
09/2009
No
Christoph Justinger, University Hospital, Saarland
University Hospital, Saarland
Not Provided
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
University Hospital, Saarland
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP