Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT01019447
Collaborator
Amygate Healthcare (Other)
701
Enrollment
2
Locations
2
Arms
15.9
Duration (Months)
350.5
Patients Per Site
22
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Vicryl Plus
  • Other: Vicryl
 Phase 4

Study Design

Study Type:
Interventional
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 :
Nov 1, 2009
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria [30 days (or 1 year in case of prosthesis)]

    Secondary Outcome Measures

    1. Post-operative hospital stay in days [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Al-Zeraaein Hospital Cairo Egypt
    2 Cairo University Kasr Al-Aini Hospital Cairo Egypt

    Sponsors and Collaborators

    • Cairo University
    • Amygate Healthcare

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01019447
    Other Study ID Numbers:
    • INDV-0909001
    First Posted:
    Nov 25, 2009
    Last Update Posted:
    Jun 22, 2011
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    Surgical site infection
    Antimicrobial triclosan-coated polyglactin 910 suture
    Length of hospital stay
    SSI
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection
    Anti-Infective Agents
    Triclosan
    Anti-Bacterial Agents

    Study Results

    No Results Posted as of Jun 22, 2011