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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Infection
Communicable Diseases
Anti-Infective Agents
Triclosan
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 22, 2014