Evaluation of Triclosan Coated Suture in Obstetrical Surgery

Sponsor

Tunis University (Other)

Overall Status

Completed

CT.gov ID

NCT05330650

Collaborator

(none)

318

Enrollment

Location

Arms

7.9

Actual Duration (Months)

40.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section; Infection	Drug: Coated Vicryl+ Drug: Vicryl	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

318 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of surgical site infection [30 days]

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecology Departement	Ben Arous		Tunisia	2096

Sponsors and Collaborators

Tunis University

Investigators

Study Director: Chaouki Mbarki, Ben Arous Hospital, Tunis, Tunisia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hajer BETTAIEB, Assistant professor, Tunis University

ClinicalTrials.gov Identifier:

NCT05330650

Other Study ID Numbers:

TunisU 1

First Posted:

Apr 15, 2022

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hajer BETTAIEB, Assistant professor, Tunis University

Surgical Site Infections

caesarean section

healthcare costs

Additional relevant MeSH terms:

Infections

Study Results

No Results Posted as of Apr 15, 2022