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Completed

NCT Number: NCT05330650

Evaluation of Triclosan Coated Suture in Obstetrical Surgery

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.

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Key information

Conditions

Cesarean Section; Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Obstetrics and Gynecology Departement

Ben Arous, 2096, Tunisia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coated Vicryl+

Drug

We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.

Vicryl

Drug

We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.

Primary outcomes

  1. Incidence of surgical site infection

    Time frame: 30 days

Secondary outcomes

  1. Health care costs attributable to surgical site infection

    Time frame: 30 days

    Evaluation of health care costs from Hospital perspective (USD)

  2. Wound healing time

    Time frame: 30 days

    Evaluation of healing time (days)

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2022
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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