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

Not Applicable

Completed

• Conditions: Cesarean Section

• Registration Number: NCT02288013
• Lead Sponsor: Mohamed Zayed

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Patient refusing to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time needed to close the uterine incision	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 Outcome Measures

Name	Time	Method
blood loss during uterine closure	intraoperative during uterine closure

Trial Locations

Locations (1)

Faculty of Medicine Cairo University; 🇪🇬 Cairo, Egypt