Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds

Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study

Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound; Surgical Wound Infection; Surgical Site Infection
• Intervention / Treatment: Drug: coated vicryl plus; Drug: Vicryl

Detailed Description

Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emad R Issak, Diploma; Phone Number: 00201272228989; Email: dr.emad.r.h.issak@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Misr Univeristy for Science and Technology Hospital
    • Contact: Moatasem-Bellah A Erfaan, MD; Phone Number: 01223478555; Email: mustmedicine@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age: 18-75
• clean-contaminated wound surgery

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coated Polyglactin 910 with Triclosan; Coated vicryl plus	Drug: coated vicryl plus; Coated Polyglactin 910 with Triclosan (coated vicryl plus); Other Names: Coated Polyglactin 910 with Triclosan
Active Comparator: Coated Polyglactin 910 without Triclosan; Coated vicryl	Drug: Vicryl; Coated Polyglactin 910 without Triclosan (vicryl); Other Names: Coated Polyglactin 910 without Triclosan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site infection	Incidence of surgical site infection within 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	duration of hospital stay	30 days

Collaborators and Investigators

• Sponsor: ClinAmygate
• Collaborators: Misr University for Science and Technology; Al Safwa Hospital; Al Zohour Hospital; Al-Menia Univeristy Hospital; MSKMC Univeristy Hospital
• Investigators: Study Director: Emad R Issak, Diploma, ClinAmygate

Publications and helpful links

General Publications

• Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjopen-2019-029727.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Estimated): October 10, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Triclosan
• Other Study ID Numbers: PR2019-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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