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The aim of this study was to ascertain if the use of Vicryl plusĀ® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon 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 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 IIĀ®, 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 plusĀ®, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDS II | No Intervention | PDS IIĀ® loop suture was used for abdominal wall closure | |
| Vicryl plus | Active Comparator | antiseptic coated "Vicryl plus" was used for abdominal wall closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicryl plus | Device | triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plusĀ®, Ethicon GmbH, Norderstedt, Germany) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome was the number of wound infections. | 10 days after demission of patient from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome was the number of incisional hernia | long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II | follow up points: 6 month, 1 year, 2 years and 3 years |
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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. | 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, D-66421 Homburg/Saar, Germany | Homburg/Saar | D-66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19231586 | Result | 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. |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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