Abdominal Wall Closure With Triclosan-coated Suture (TCS09)

June 14, 2012 updated by: University of Pecs

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

After open colorectal 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 separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After open colorectal 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 separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material 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 panel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events

  • complications
  • control examination

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Pecs, Hungary, 7624
        • Department of Surgery Medical Faculty, University of Pecs, Hungary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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 unprepared 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: triclosan
Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
Procedure: abdominal wall closure
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Other Names:
  • presence of surgical site infection
  • level of surgical site infection
EXPERIMENTAL: uncoated
Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
Procedure: surgical site infection
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Other Names:
  • presence of surgical site infection
  • level of surgical site infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality and quantity of wound discharge
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
number of applied different types of bandages
Time Frame: 30 days
30 days
charges of wound care
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Principal Investigator: Ors Peter Horvath, MD, PhD, DSc, Head of Surg.Dept. Univ. of Pecs, Hungary - ophorvath@iseb.pote.hu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • triclosan-coated-suture2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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