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

NCT ID: NCT02288013

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Stratafix Tissue control device

Closure of Uterine incision at C section

Group Type OTHER

Closure of uterine incision at C section

Intervention Type PROCEDURE

Closure of uterine incision at Cesarean section

Vicryl suture

Closure of uterine incision at C section

Group Type OTHER

Closure of uterine incision at C section

Intervention Type PROCEDURE

Closure of uterine incision at Cesarean section

Interventions

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Closure of uterine incision at C section

Closure of uterine incision at Cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient refusing to participate in the study
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Johnson & Johnson Medical Companies

INDUSTRY

Sponsor Role collaborator

Mohamed Zayed

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Zayed

Professor of Obstetrics and Gynecology Cairo University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed Z Ahmed, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Medicine Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IIS 13-207

Identifier Type: -

Identifier Source: org_study_id

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