Wound Infection Clinical Trial
Official title:
Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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