Evaluation of Triclosan Coated Suture in Obstetrical Surgery

Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study

A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.

The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Infection
• Intervention / Treatment: Drug: Coated Vicryl+; Drug: Vicryl

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Ben Arous, Tunisia, 2096
    • Obstetrics and Gynecology Departement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women with indicated cesarean delivery and who have signed a written consent.

Exclusion Criteria:

• Cases with incomplete follow up
• Breach of operative protocol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Triclosan coated suture	Drug: Coated Vicryl+; We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.
Active Comparator: Non coated suture	Drug: Vicryl; We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of surgical site infection	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care costs attributable to surgical site infection	Evaluation of health care costs from Hospital perspective (USD)	30 days
Wound healing time	Evaluation of healing time (days)	30 days

Collaborators and Investigators

• Sponsor: Tunis University
• Investigators: Study Director: Chaouki Mbarki, Ben Arous Hospital, Tunis, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: caesarean section; Surgical Site Infections; healthcare costs
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: TunisU 1

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: No
• Studies a U.S. FDA-regulated device product: No