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

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ClinicalTrials.gov Identifier: NCT01019447
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Amygate Healthcare
Information provided by:
Cairo University

Brief Summary:
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 or disease Intervention/treatment Phase
Surgical Site Infection Other: Vicryl Plus Other: Vicryl Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
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.
Study Start Date : November 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Triclosan
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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 :
  1. Post-operative hospital stay in days [ Time Frame: 30 days ]


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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

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

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 Posted: November 25, 2009    Key Record Dates
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