The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection

June 21, 2011 updated by: Cairo University

"The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection" Prospective, Randomized, Controlled, Double Blind, Multi-centre Study.

To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

701

Phase

  • Phase 4

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

  • Egypt
      • Cairo, Egypt
        • Al-Zeraaein Hospital
      • Cairo, Egypt
        • Cairo University Kasr Al-Aini Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients of different age
  • Gender
  • Risk factors and procedures candidate for surgical intervention during the period of the study

Exclusion Criteria:

  • Patients with an established pre-operative infection at the operative site

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
ACTIVE_COMPARATOR: Study group
The study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used.
Other: Vicryl Plus
Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)
Other Names:
  • Triclosan-coated polyglactin 910 antimicrobial sutures
ACTIVE_COMPARATOR: Control group
The control group in which polyglactin 910 antimicrobial sutures will be used.
Other: Vicryl
Polyglactin 910 antimicrobial sutures (Vicryl)
Other Names:
  • Polyglactin 910 antimicrobial sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria
Time Frame: 30 days (or 1 year in case of prosthesis)
30 days (or 1 year in case of prosthesis)

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative hospital stay in days
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

Amygate Healthcare

Investigators

  • Principal Investigator: Ibrahim Ga Ibrahim, MD, Cairo University

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)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (ESTIMATE)

November 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INDV-0909001

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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