Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section

Phase 3

Completed

• Conditions: Cesarean Section
• Interventions: Device: polyglactin 910; Device: Knotless barbed suture

• Registration Number: NCT02962011
• Lead Sponsor: Ziv Hospital

Brief Summary

This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-11
• Primary Completion: 2017-03-31
• Study Completion: 2017-08
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• elective cesarean
• elective repeat cesarean

Exclusion Criteria

• emergent or urgent cesarean
• PROM
• chorioamninitis
• placental abruption
• placenta previa or accreta
• known uterine fibroids
• women with known medical problems such as coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polyglactin 910	polyglactin 910	Vicryl
Knotless barbed suture	Knotless barbed suture	-

Primary Outcome Measures

Name	Time	Method
Uterine incision closure time	5 months	uterine incision closure time

Secondary Outcome Measures

Name	Time	Method
uterine incision blood loss	5 months	uterine incision blood loss
hemostatic suture use	5 months	hemostatic suture use

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Zefat, Israel