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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962011 on ClinicalTrials.gov