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NCT02962011 Clinical Trial

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

Cesarean Section Clinical Trial

— barbed  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02962011
Other study ID # ZIVH
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 1, 2016
Est. completion date August 2017

Study information
Verified date June 2018
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date August 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Knotless barbed suture
uterine incision closure
• polyglactin 910
uterine incision closure

Locations
Country Name City State
Israel Ziv Medical Center Zefat

Sponsors (1)
Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Uterine incision closure time uterine incision closure time 5 months
Secondary uterine incision blood loss uterine incision blood loss 5 months
Secondary hemostatic suture use hemostatic suture use 5 months
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