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The aim of this study is to ascertain if the use of PDS plusĀ® 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 plusĀ®, Ethicon GmbH, Norderstedt, Germany). In the second time period the CP step will be altered to the use of PDS loop suture (PDS IIĀ®, 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDS II | Active Comparator | PDS IIĀ® loop suture is used for abdominal wall closure |
|
| PDS plus | Experimental | antibacterial coated "PDS plus" is used for abdominal wall closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDS plus | Device | triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plusĀ®, Ethicon GmbH, Norderstedt, Germany) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of wound infections | 30 days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| The number of incisional hernias. | 6 month | |
| The number of incisional hernia- long time follow up | number of incisional hernia after 24 month | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Justinger, M.D. | Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany | Principal Investigator |
| Martin K Schilling, M.D., FRCS | Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, | Homburg/Saar | D-66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19231586 | Background | 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. | |
| 23859304 | Derived | 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. |
| Label | URL |
|---|---|
| Dept. of General Surgery, Visceral, Vascular and Pediatric Surgery, University Hospital of Saarland | View source |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| PDS II | Device | polyglactin 910 suture material for abdominal wall closure |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |