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

Primary Purpose

Cesarean Section

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Knotless barbed suture
polyglactin 910
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring Cesarean, incision, suture,

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ziv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Knotless barbed suture

polyglactin 910

Arm Description

Vicryl

Outcomes

Primary Outcome Measures

Uterine incision closure time
uterine incision closure time

Secondary Outcome Measures

uterine incision blood loss
uterine incision blood loss
hemostatic suture use
hemostatic suture use

Full Information

First Posted
November 9, 2016
Last Updated
June 25, 2018
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02962011
Brief Title
Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
Acronym
barbed
Official Title
Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziv Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
Cesarean, incision, suture,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Knotless barbed suture vs conventional suture of uterine incision
Masking
Participant
Masking Description
unblinded
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knotless barbed suture
Arm Type
Experimental
Arm Title
polyglactin 910
Arm Type
Active Comparator
Arm Description
Vicryl
Intervention Type
Device
Intervention Name(s)
Knotless barbed suture
Other Intervention Name(s)
Stratafix
Intervention Description
uterine incision closure
Intervention Type
Device
Intervention Name(s)
polyglactin 910
Other Intervention Name(s)
Vicryl
Intervention Description
uterine incision closure
Primary Outcome Measure Information:
Title
Uterine incision closure time
Description
uterine incision closure time
Time Frame
5 months
Secondary Outcome Measure Information:
Title
uterine incision blood loss
Description
uterine incision blood loss
Time Frame
5 months
Title
hemostatic suture use
Description
hemostatic suture use
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Peleg
Organizational Affiliation
Ziv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziv Medical Center
City
Zefat
ZIP/Postal Code
13100
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29496259
Citation
Peleg D, Ahmad RS, Warsof SL, Marcus-Braun N, Sciaky-Tamir Y, Ben Shachar I. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery. Am J Obstet Gynecol. 2018 Mar;218(3):343.e1-343.e7. doi: 10.1016/j.ajog.2018.01.043. Epub 2018 Feb 5.
Results Reference
derived

Learn more about this trial

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

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