PDS*Plus and Wound Infections After Laparotomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures

Conditions
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Wound Infection, Incisional Hernia

Intervention / Treatment
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* Device: PDS plus
* Device: PDS II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PDS II<br>PDS II® loop suture is used for abdominal wall closure | Device: PDS II<br>* polyglactin 910 suture material for abdominal wall closure<br>|
| Experimental: PDS plus<br>antibacterial coated PDS plus is used for abdominal wall closure | Device: PDS plus<br>* triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)<br>* Other names: PDS plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of wound infections |  | 30 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incisional hernias. |  | 6 month | 
| The number of incisional hernia- long time follow up | number of incisional hernia after 24 month | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Abdominal Surgery, Fascial Closure