Evaluation of Triclosan Coated Suture in Obstetrical Surgery

Phase 4

Completed

• Conditions: Cesarean Section; Infection
• Interventions: Drug: Coated Vicryl+; Drug: Vicryl

• Registration Number: NCT05330650
• Lead Sponsor: Tunis University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-30
• Study First Submitted: 2022-03-21
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-08
• Last Update Submitted: 2022-04-08
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 318

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triclosan coated suture	Coated Vicryl+	-
Non coated suture	Vicryl	-

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site infection	30 days

Secondary Outcome Measures

Name	Time	Method
Health care costs attributable to surgical site infection	30 days	Evaluation of health care costs from Hospital perspective (USD)
Wound healing time	30 days	Evaluation of healing time (days)

Trial Locations

Locations (1)

Obstetrics and Gynecology Departement; 🇹🇳 Ben Arous, Tunisia