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

January 26, 2016 updated by: Mohamed Zayed
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11559
        • Faculty of medicine Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stratafix Tissue control device
Closure of Uterine incision at C section
Procedure: Closure of uterine incision at C section
Closure of uterine incision at Cesarean section
Other: Vicryl suture
Closure of uterine incision at C section
Procedure: Closure of uterine incision at C section
Closure of uterine incision at Cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
blood loss during uterine closure
Time Frame: intraoperative during uterine closure
intraoperative during uterine closure

Other Outcome Measures

Outcome Measure
Time Frame
Duration of hospital stay
Time Frame: Six weeks following the cesarean delivery (completion of the postpartum period)
Six weeks following the cesarean delivery (completion of the postpartum period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Zayed

Collaborators

Cairo University
Johnson & Johnson Medical Companies

Investigators

  • Principal Investigator: Mohamed Z Ahmed, MD PhD, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIS 13-207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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