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NCT05330650 Clinical Trial

Evaluation of Triclosan Coated Suture in Obstetrical Surgery

Cesarean Section; Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05330650
Other study ID # TunisU 1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2020
Est. completion date June 30, 2021

Study information
Verified date April 2022
Source Tunis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 318
Est. completion date June 30, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Coated Vicryl+
We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.
• Vicryl
We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.

Locations
Country Name City State
Tunisia Obstetrics and Gynecology Departement Ben Arous

Sponsors (1)
Lead Sponsor Collaborator
Tunis University

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of surgical site infection 30 days
Secondary Health care costs attributable to surgical site infection Evaluation of health care costs from Hospital perspective (USD) 30 days
Secondary Wound healing time Evaluation of healing time (days) 30 days
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