Antiseptic Sutures and Wound Infection

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.

Conditions
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Wound Infection

Intervention / Treatment
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* Device: Vicryl plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: surgical pathologies accessed via transverse abdominal incision primary fascial closure Exclusion Criteria: pregnancy age under 18 years open abdominal treatment known hypersensitivity agains PDS/Vicryl/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: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PDS II<br>PDS II® loop suture was used for abdominal wall closure | |
| Active Comparator: Vicryl plus<br>antiseptic coated Vicryl plus was used for abdominal wall closure | Device: Vicryl plus<br>* triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)<br>* Other names: Vicryl plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the number of wound infections. |  | 10 days after demission of patient from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome was the number of incisional hernia | long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II | follow up points: 6 month, 1 year, 2 years and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vicryl plus, wound infection, coated suture material, open abdominal surgery, transverse laparotomy