NCT03159871

Brief Summary

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2017

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

May 16, 2017

Last Update Submit

May 30, 2018

Conditions

Cesarean Section

Keywords

Cesarean sectionC- sectionSuture

Outcome Measures

Primary Outcomes (1)

  • Time required for uterine closure.

    Time measured in minutes and seconds

    From the beginning of first uterine suture till the last suture ending uterine incision complete closure and any additional hemostatic sutures if applicable. The estimated period of time is 8 minutes (average).

Secondary Outcomes (1)

  • Blood loss during uterine closure

    Estimated period of time is 4 days.

Study Arms (2)

Stratafix suture

EXPERIMENTAL
Device: Stratafix suture

Vicryl suture

ACTIVE COMPARATOR
Device: Vicryl suture

Interventions

Stratafix sutureDEVICE

Stratafix barbed sutures during C-Sections.

Stratafix suture
Vicryl sutureDEVICE

Standart Vicryl suture during C- Sections.

Vicryl suture

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant patients with an obstetrical indication for delivery by Cesarean section

You may not qualify if:

  • Patients with blood clotting disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai Medical Center

Ashkelon, Israel

Location

Related Publications (2)

  • Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.

    PMID: 24920976BACKGROUND

  • Giampaolino P, De Rosa N, Tommaselli GA, Santangelo F, Nappi C, Sansone A, Bifulco G. Comparison of bidirectional barbed suture Stratafix and conventional suture with intracorporeal knots in laparoscopic myomectomy by office transvaginal hydrolaparoscopic follow-up: a preliminary report. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:146-150. doi: 10.1016/j.ejogrb.2015.10.011. Epub 2015 Oct 24.

    PMID: 26540594BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecological Doctor

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

June 29, 2016

Primary Completion

December 21, 2017

Study Completion

December 24, 2017

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations

IL(1)