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

Phase 2

• Conditions: Wound Infection
• Interventions: Procedure: abdominal wall closure

• Registration Number: NCT01123616
• Lead Sponsor: University of Pecs

Brief Summary

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

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

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-04
• Status Verified: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-12
• Last Update Submitted: 2010-05-12
• Study First Posted: 2010-05-14
• Last Update Posted: 2010-05-14
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Elective (subjected to bowel preparation) operations
• Benign or malignsnt colon or rectal disease
• Age: 18-80
• Bowel opening is made during operation

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Exclusion Criteria

1. 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

2. 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

3. Undesirable complication:

Sterile surgical site separation Suture break during the post-operational stage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-triclosan-coated	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 coated suture	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).

Primary Outcome Measures

Name	Time	Method
quality and quantity of wound discharge	30 days

Secondary Outcome Measures

Name	Time	Method
number of applied different types of bandages	30 days
charges of wound care	30 days

Trial Locations

Locations (1)

Department of Surgery Medical Faculty, University of Pecs, Hungary; 🇭🇺 Pecs, Hungary