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

This study has been completed.
Sponsor:
Collaborator:
Amygate Healthcare
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01019447
First received: November 23, 2009
Last updated: June 21, 2011
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative hospital stay in days [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019447

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

No publications provided

Responsible Party: Ibrahim Galal Ibrahim, Cairo University Kasr Al-Aini Hospitals
ClinicalTrials.gov Identifier: NCT01019447     History of Changes
Other Study ID Numbers: INDV-0909001
Study First Received: November 23, 2009
Last Updated: June 21, 2011
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Anti-Infective Agents
Triclosan
Hexachlorophene
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions
 Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 18, 2013