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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019447
First Posted: November 25, 2009
Last Update Posted: June 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amygate Healthcare
Information provided by:
Cairo University
  Purpose
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.

Condition Intervention Phase
Surgical Site Infection Other: Vicryl Plus Other: Vicryl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection" Prospective, Randomized, Controlled, Double Blind, Multi-centre Study.

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Post-operative hospital stay in days [ Time Frame: 30 days ]

Enrollment: 701
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Polyglactin 910 antimicrobial sutures

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019447


Locations
Egypt
Al-Zeraaein Hospital
Cairo, Egypt
Cairo University Kasr Al-Aini Hospital
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Amygate Healthcare
Investigators
Principal Investigator: Ibrahim Ga Ibrahim, MD Cairo University
  More Information

Responsible Party: Ibrahim Galal Ibrahim, Cairo University Kasr Al-Aini Hospitals
ClinicalTrials.gov Identifier: NCT01019447     History of Changes
Other Study ID Numbers: INDV-0909001
First Submitted: November 23, 2009
First Posted: November 25, 2009
Last Update Posted: June 22, 2011
Last Verified: November 2009

Keywords provided by Cairo University:
Surgical site infection
Antimicrobial triclosan-coated polyglactin 910 suture
Length of hospital stay
SSI

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents
Triclosan
Anti-Bacterial Agents
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents