NCT02288013

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mohamed Zayed · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
PROCEDURE	Closure of uterine incision at C section	Closure of uterine incision at Cesarean section

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-11-11
• Last updated: 2016-01-27

Locations

1 site across 1 country: Egypt