Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1042 participants
INTERVENTIONAL
2009-09-30
2012-01-31
Brief Summary
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Antiseptic Sutures and Wound Infection
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PDS II
PDS II® loop suture is used for abdominal wall closure
PDS II
polyglactin 910 suture material for abdominal wall closure
PDS plus
antibacterial coated "PDS plus" is used for abdominal wall closure
PDS plus
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
Interventions
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PDS plus
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
PDS II
polyglactin 910 suture material for abdominal wall closure
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 against PDS/Triclosan
18 Years
ALL
No
Sponsors
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University Hospital, Saarland
OTHER
Responsible Party
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Christoph Justinger
Priciple Investigator
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., FRCS
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,
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.
Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.
Related Links
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Dept. of General Surgery, Visceral, Vascular and Pediatric Surgery, University Hospital of Saarland
Other Identifiers
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09/2009
Identifier Type: -
Identifier Source: org_study_id
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