Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
NCT02962011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2018-06-27
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
- DEVICE
-
Knotless barbed suture
uterine incision closure
- DEVICE
-
polyglactin 910
uterine incision closure
Sponsors & Collaborators
-
Ziv Hospital
lead OTHER_GOV
Principal Investigators
-
David Peleg · Ziv Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-01
- Primary Completion
- 2017-03-31
- Completion
- 2017-08-31
Countries
- Israel
Study Locations
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