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

Cesarean Section Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288013
• Other study ID #: IIS 13-207
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: January 26, 2016
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt : Research Ethical Committee Cairo University Medical School
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient refusing to participate in the study

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Procedure:
• Closure of uterine incision at C section
Closure of uterine incision at Cesarean section

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Mohamed Zayed	Cairo University, Johnson & Johnson Medical Companies

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of hospital stay		Six weeks following the cesarean delivery (completion of the postpartum period)	No
Primary	Time needed to close the uterine incision	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	6 minutes	No
Secondary	blood loss during uterine closure		intraoperative during uterine closure	Yes