NCT02962011

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Ziv Hospital · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DEVICE	Knotless barbed suture	uterine incision closure
DEVICE	polyglactin 910	uterine incision closure

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-31
• Completion: 2017-08-01
• First posted: 2016-11-11
• Last updated: 2018-06-27

Locations

1 site across 1 country: Israel