An interventional study of PDS plus and PDS II in Wound Infection and Incisional Hernia, sponsored by University Hospital, Saarland. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-18.
Sponsored by University Hospital, Saarland · Not applicable, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,042 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University Hospital, Saarland is the lead sponsor of 41 studies on the registry; none are open to participants now.
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Exclusion Criteria:
PDS II® loop suture is used for abdominal wall closure
Device: PDS II
antibacterial coated "PDS plus" is used for abdominal wall closure
Device: PDS plus
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
Also known as: PDS plus®
polyglactin 910 suture material for abdominal wall closure
The number of wound infections
Time frame: 30 days after the operation
The number of incisional hernias.
Time frame: 6 month
The number of incisional hernia- long time follow up
number of incisional hernia after 24 month
Time frame: 12 month
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Saarland