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Completed

NCT Number: NCT02288013

Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study

Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.

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Key information

Conditions

Cesarean Section

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Cairo University

Cairo, Cairo Governorate, 11559, Egypt

About this study

A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All pregnant patients with an indication for delivery by C section

Exclusion criteria

  • Patient refusing to participate in the study

Treatment and study plan

Closure of uterine incision at C section

Procedure

Closure of uterine incision at Cesarean section

Primary outcomes

  1. Time needed to close the uterine incision

    Time frame: 6 minutes

    A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes

Secondary outcomes

  1. blood loss during uterine closure

    Time frame: intraoperative during uterine closure

Other outcomes

  1. Duration of hospital stay

    Time frame: Six weeks following the cesarean delivery (completion of the postpartum period)

Sponsors and collaborators

Lead sponsor

Mohamed Zayed

Other

Collaborators

  • Cairo University
  • Johnson & Johnson Medical Companies

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2014
Registry last updated
Jan 27, 2016

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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