Incisional Hernia, Wound Infection
Conditions
Keywords
Open Abdominal Surgery, Fascial Closure
Brief summary
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.
Detailed description
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.
Interventions
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
polyglactin 910 suture material for abdominal wall closure
Sponsors
Study design
Eligibility
Inclusion criteria
* surgical pathologies accessed via midline or transverse abdominal incision * primary fascial closure
Exclusion criteria
* pregnancy * age under 18 years * open abdominal treatment * known hypersensitivity against PDS/Triclosan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of wound infections | 30 days after the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of incisional hernias. | 6 month | — |
| The number of incisional hernia- long time follow up | 12 month | number of incisional hernia after 24 month |
Countries
Germany