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Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

NCT ID: NCT03159871

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-29

Study Completion Date

2017-12-24

Brief Summary

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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.

Detailed Description

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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. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Conditions

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Cesarean Section

Keywords

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Cesarean section C- section Suture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Stratafix suture

Group Type EXPERIMENTAL

Stratafix suture

Intervention Type DEVICE

Stratafix barbed sutures during C-Sections.

Vicryl suture

Group Type ACTIVE_COMPARATOR

Vicryl suture

Intervention Type DEVICE

Standart Vicryl suture during C- Sections.

Interventions

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Stratafix suture

Stratafix barbed sutures during C-Sections.

Intervention Type DEVICE

Vicryl suture

Standart Vicryl suture during C- Sections.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Patients with blood clotting disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leon Grin

Gynecological Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barzilai Medical Center

Ashkelon, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 24920976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26540594 (View on PubMed)

Other Identifiers

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BRZ 0018-16 CTIL

Identifier Type: -

Identifier Source: org_study_id