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Completed

NCT Number: NCT04255927

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

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.

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Key information

Conditions

Laparoscopic Surgery Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Misr Univeristy for Science and Technology Hospital

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coated Vicryl plus

Drug

Vicryl plus (Coated Polyglactin 910 with Triclosan)

Other names: Coated Polyglactin 910 with Triclosan

Coated vicryl

Drug

Vicryl (Coated Polyglactin 910 without Triclosan)

Other names: Coated Polyglactin 910 without Triclosan

Primary outcomes

  1. port site infection (PSI)

    Time frame: 30 days

    the incidence of port site infection (PSI)

Secondary outcomes

  1. hospital stay

    Time frame: 30 days

    Post-operative hospital stay in days

Sponsors and collaborators

Lead sponsor

ClinAmygate

Other

Collaborators

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

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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