Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section

June 12, 2017 updated by: Usama M Fouda, Cairo University

Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section; a Randomized Controlled Study

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with more postoperative adhesions compared with conventional sutures or not.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with an increase in the rate of postoperative adhesions compared with conventional sutures or not. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures.Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Study Type

Interventional

Enrollment (Anticipated)

110

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
        • 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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

  • Previous laparotomies
  • Postoperative fever
  • Patients with preterm pregnancies or in labor

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Barbed suture ( STRATAFIX™ )
Cesarean section incision is closed using barbed sutures
Device: Barbed suture ( STRATAFIX™ )
Cesarean section incision will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.
ACTIVE_COMPARATOR: Conventional suture (VICRYL™)
Cesarean section incision is closed using conventional sutures
Device: Conventional suture (VICRYL™)
Cesarean section incision will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesions formation rate
Time Frame: Through study completion, an average of 3 year
Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.
Through study completion, an average of 3 year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Usama M. Fouda, Prof., Cairo University
  • Study Chair: Mohamed Zayed, Prof., 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 (ANTICIPATED)

August 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (ACTUAL)

June 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Barbed sutures adhesions

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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