Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

NCT ID: NCT02517710

Last Updated: 2018-08-10

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Detailed Description

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Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Conditions

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Hysterotomy Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Group of patients receiving standard hysterotomy closure with synthetic braided suture

Group Type PLACEBO_COMPARATOR

Stratafix synthetic barbed suture

Intervention Type PROCEDURE

hysterotomy closure in Cesarian section

Stratfix

group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain

Group Type EXPERIMENTAL

Stratafix synthetic barbed suture

Intervention Type PROCEDURE

hysterotomy closure in Cesarian section

Interventions

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Stratafix synthetic barbed suture

hysterotomy closure in Cesarian section

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion Criteria

* General Anesthesia
* Non-consent to participation
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Russell J.Stankiewicz, MD

UNKNOWN

Sponsor Role collaborator

Ob/GYN Associates of Evangelical Hospital

UNKNOWN

Sponsor Role collaborator

The Commonwealth Medical College

UNKNOWN

Sponsor Role collaborator

Nickolas Serniak, BS, MS 4

UNKNOWN

Sponsor Role collaborator

Neil Cooper, MS, MS 4

UNKNOWN

Sponsor Role collaborator

Jennifer L. MacDonald, PA

UNKNOWN

Sponsor Role collaborator

Evangelical Community Hospital, Lewisburg, PA

OTHER

Sponsor Role lead

Responsible Party

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Russell J. Stankiewicz, MD

Assistant Clinical professor OB/GYN, Family Medicine, The Commonwealth Medical College

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Evangelical Community Hospital

Lewisburg, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ECH/TCMC101

Identifier Type: -

Identifier Source: org_study_id

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