Wound Infection Clinical Trial
Official title:
Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.
The aim of this study was to ascertain if the use of Vicryl plus® 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 II®, 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 plus®, 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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Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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