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Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.

Sponsor
ClinAmygate (Other)
Overall Status
Completed
CT.gov ID
NCT04255927
Collaborator
Misr University for Science and Technology (Other), Al Safwa Hospital (Other), Fayoum University Hospital (Other)
912
Enrollment
1
Location
2
Arms
26.4
Actual Duration (Months)
34.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Coated Vicryl plus
  • Drug: Coated vicryl
 Phase 4

Detailed Description

In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Study Design

Study Type:
Interventional
Actual Enrollment :
912 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized-controlledrandomized-controlled
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.
Actual Study Start Date :
Feb 5, 2020
Actual Primary Completion Date :
Mar 10, 2022
Actual Study Completion Date :
Apr 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Coated Polyglactin 910 with Triclosan

Coated Polyglactin 910 with Triclosan

Drug: Coated Vicryl plus
Vicryl plus (Coated Polyglactin 910 with Triclosan)
Other Names:
  • Coated Polyglactin 910 with Triclosan

    		•
    Active Comparator: Coated Polyglactin 910 without Triclosan

    Coated Polyglactin 910 without Triclosan

    Drug: Coated vicryl
    Vicryl (Coated Polyglactin 910 without Triclosan)
    Other Names:
  • Coated Polyglactin 910 without Triclosan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. port site infection (PSI) [30 days]

      the incidence of port site infection (PSI)

    Secondary Outcome Measures

    1. hospital stay [30 days]

      Post-operative hospital stay in days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age 18-75

    • candidate for laparoscopic surgical intervention during the period of the study were included.

    Exclusion Criteria:

    • Patient has immunodeficiency disorder.

    • Patient receiving anti-cancer / immunosuppressive therapy.

    • Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Misr Univeristy for Science and Technology Hospital Giza Egypt

    Sponsors and Collaborators

    • ClinAmygate
    • Misr University for Science and Technology
    • Al Safwa Hospital
    • Fayoum University Hospital

    Investigators

    • Study Director: Emad R Issak, Diploma, ClinAmygate

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emad R Issak, Doctor, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04255927
    Other Study ID Numbers:
    • PR2019-26
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection
    Surgical Wound
    Triclosan

    Study Results

    No Results Posted as of May 11, 2022