NCT02962011

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

November 9, 2016

Last Update Submit

June 25, 2018

Conditions

Cesarean Section

Keywords

Cesarean, incision, suture,

Outcome Measures

Primary Outcomes (1)

  • Uterine incision closure time

    uterine incision closure time

    5 months

Secondary Outcomes (2)

  • uterine incision blood loss

    5 months

  • hemostatic suture use

    5 months

Study Arms (2)

Knotless barbed suture

EXPERIMENTAL
Device: Knotless barbed suture

polyglactin 910

ACTIVE COMPARATOR

Vicryl

Device: polyglactin 910

Interventions

Knotless barbed sutureDEVICE

uterine incision closure

Also known as: Stratafix
Knotless barbed suture
polyglactin 910DEVICE

uterine incision closure

Also known as: Vicryl
polyglactin 910

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective cesarean
  • elective repeat cesarean

You may not qualify if:

  • emergent or urgent cesarean
  • PROM
  • chorioamninitis
  • placental abruption
  • placenta previa or accreta
  • known uterine fibroids
  • women with known medical problems such as coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 29496259DERIVED

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • David Peleg

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
unblinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Knotless barbed suture vs conventional suture of uterine incision
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

August 1, 2016

Primary Completion

March 31, 2017

Study Completion

August 1, 2017

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

IL(1)