PDS*Plus and Wound Infections After Laparotomy (PDS*plus)
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| First Received Date ICMJE | October 20, 2009 | ||||||||
| Last Updated Date | January 17, 2012 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The number of wound infections [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00998907 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
The number of incisional hernias. [ Time Frame: 6 month ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | PDS*Plus and Wound Infections After Laparotomy | ||||||||
| Official Title ICMJE | Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures | ||||||||
| 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. |
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| 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 ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibiotic coating of abdominal closure sutures and wound infection. Surgery. 2009 Mar;145(3):330-4. Epub 2009 Jan 25. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 1042 | ||||||||
| Completion Date | January 2012 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00998907 | ||||||||
| Other Study ID Numbers ICMJE | 09/2009 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christoph Justinger, University Hospital, Saarland | ||||||||
| Study Sponsor ICMJE | University Hospital, Saarland | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Saarland | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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