Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section (barbed)

June 25, 2018 updated by: David Peleg, Ziv Hospital

Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section

This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

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

  • Israel
      • Zefat, Israel, 13100
        • Ziv Medical Center

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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • elective cesarean
  • elective repeat cesarean

Exclusion Criteria:

  • emergent or urgent cesarean
  • PROM
  • chorioamninitis
  • placental abruption
  • placenta previa or accreta
  • known uterine fibroids
  • women with known medical problems such as coagulopathy

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Knotless barbed suture
Device: Knotless barbed suture
uterine incision closure
Other Names:
  • Stratafix
ACTIVE_COMPARATOR: polyglactin 910
Vicryl
Device: polyglactin 910
uterine incision closure
Other Names:
  • Vicryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine incision closure time
Time Frame: 5 months
uterine incision closure time
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uterine incision blood loss
Time Frame: 5 months
uterine incision blood loss
5 months
hemostatic suture use
Time Frame: 5 months
hemostatic suture use
5 months

Collaborators and Investigators

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

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: David Peleg, Ziv Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

March 31, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (ESTIMATE)

November 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIVH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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