Study Results
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Basic Information
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COMPLETED
NA
839 participants
INTERVENTIONAL
2003-10-31
2007-10-31
Brief Summary
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Detailed Description
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Wound closure is achieved by a two-layer technique 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 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. 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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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PDS II
PDS II® loop suture was used for abdominal wall closure
No interventions assigned to this group
Vicryl plus
antiseptic coated "Vicryl plus" was used for abdominal wall closure
Vicryl plus
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
Interventions
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Vicryl plus
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* primary fascial closure
Exclusion Criteria
* age under 18 years
* open abdominal treatment
* known hypersensitivity agains PDS/Vicryl/Triclosan
18 Years
ALL
No
Sponsors
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University Hospital, Saarland
OTHER
Responsible Party
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Christoph Justinger
Christoph Justinger, MDDepartment of General, Visceral, Vascular, and Pediatric Surgery
Principal Investigators
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Christoph Justinger, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Martin K Schilling, M.D.
Role: STUDY_DIRECTOR
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Locations
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Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Homburg/Saar, , Germany
Countries
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References
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Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibacterial [corrected] coating of abdominal closure sutures and wound infection. Surgery. 2009 Mar;145(3):330-4. doi: 10.1016/j.surg.2008.11.007. Epub 2009 Jan 25.
Other Identifiers
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Vicryl plus 1
Identifier Type: -
Identifier Source: org_study_id
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