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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02288013

Enrollment

100

Registered

2014-11-11

Start date

2013-10-31

Completion date

2014-12-31

Last updated

2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Cesarean section, uterine closure technique, materials used

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.

Interventions

PROCEDUREClosure of uterine incision at C section

Closure of uterine incision at Cesarean section

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patient refusing to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
blood loss during uterine closure	intraoperative during uterine closure

Other

Measure	Time frame
Duration of hospital stay	Six weeks following the cesarean delivery (completion of the postpartum period)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026