Skip to main content
OpenTrials
Completed

NCT Number: NCT02962011

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section Surgical Wound Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ziv Medical Center

Safed, 13100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knotless barbed suture

Device

uterine incision closure

Other names: Stratafix

polyglactin 910

Device

uterine incision closure

Other names: Vicryl

Primary outcomes

  1. Uterine incision closure time

    Time frame: 5 months

    uterine incision closure time

Secondary outcomes

  1. uterine incision blood loss

    Time frame: 5 months

    uterine incision blood loss

  2. hemostatic suture use

    Time frame: 5 months

    hemostatic suture use

Sponsors and collaborators

Lead sponsor

Ziv Hospital

Other Gov

Registry information

Official study title

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

Acronym: barbed

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.