Abdominal Wall Closure With Triclosan-coated Suture (TCS09-10)

Study Overview
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Brief Summary
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After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.

Detailed Description
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After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic materia which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation. attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID pannel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events complications control examination

Official Title
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Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material

Conditions
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Wound Infection

Intervention / Treatment
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* Procedure: abdominal wall closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective (subjected to bowel preparation) operations Benign or malignsnt colon or rectal disease Age: 18-80 Bowel opening is made during operation Exclusion Criteria: Cannot be randomized: Systemic diseases influencing local surgical site healing Insulin-dependent diabetes mellitus Child B-C liver cirrhosis Kidney disease requiring dialysis Immune-suppression treatment IBD Acute surgery or unpreparated bowel After being informed patient does not sign the statement of consent To be excluded later: Surgically incurable tumour Septic state or complication occurred in the post-operational stage Patient withdraws the signed consent before the examination is closed Undesirable complication: Sterile surgical site separation Suture break during the post-operational stage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-triclosan-coated<br>Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). | Procedure: abdominal wall closure<br>* triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall<br>* Other names: level of surgical site infection;|
| Active Comparator: triclosan coated suture<br>Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). | Procedure: abdominal wall closure<br>* triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall<br>* Other names: level of surgical site infection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality and quantity of wound discharge |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of applied different types of bandages |  | 30 days | 
| charges of wound care |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical site infection, elective colorectal surgery, level of surgical site infection, complication of surgical site infection, type of changed bandage, frequency of bandage changing