Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Device: Vicryl suture; Device: Stratafix suture

• Registration Number: NCT03159871
• Lead Sponsor: Barzilai Medical Center

Brief Summary

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.

Detailed Description

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Study Timeline

• Study Start: 2016-06-29
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-24
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

• Pregnant patients with an obstetrical indication for delivery by Cesarean section

Exclusion Criteria

• Patients with blood clotting disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vicryl suture	Vicryl suture	-
Stratafix suture	Stratafix suture	-

Primary Outcome Measures

Name	Time	Method
Time required for uterine closure.	From the beginning of first uterine suture till the last suture ending uterine incision complete closure and any additional hemostatic sutures if applicable. The estimated period of time is 8 minutes (average).	Time measured in minutes and seconds

Secondary Outcome Measures

Name	Time	Method
Blood loss during uterine closure	Estimated period of time is 4 days.	Intraoperative during uterine closure and by blood work during post-operative hospital stay

Trial Locations

Locations (1)

Barzilai Medical Center; 🇮🇱 Ashqelon, Israel