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

M

Mohamed Zayed

Status

Completed

Conditions

Cesarean Section

Treatments

Procedure: Closure of uterine incision at C section

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02288013
IIS 13-207

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Patient refusing to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

100 participants in 2 patient groups

Stratafix Tissue control device
Other group
Description:
Closure of Uterine incision at C section
Treatment:
Procedure: Closure of uterine incision at C section
Vicryl suture
Other group
Description:
Closure of uterine incision at C section
Treatment:
Procedure: Closure of uterine incision at C section

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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