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

Information source: Evangelical Community Hospital, Lewisburg, PA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hysterotomy Closure

Intervention: Stratafix synthetic barbed suture (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Evangelical Community Hospital, Lewisburg, PA

Overall contact:
Russell J Stankiewicz, MD, Phone: 5705238700, Ext: 228, Email: rstankiewicz@evanhospital.com

Summary

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

Clinical Details

Official title: Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Blood loss in closure with barbed synthetic suture

Secondary outcome: Post operative pain after cesarean secton

Detailed description: 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.

Eligibility

Minimum age: 16 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women of childbearing age undergoing primary or repeat cesarean section using

regional anesthesia. Exclusion Criteria:

- General Anesthesia

- Non-consent to participation

Locations and Contacts

Russell J Stankiewicz, MD, Phone: 5705238700, Ext: 228, Email: rstankiewicz@evanhospital.com

Evangelical Community Hospital, Lewisburg, Pennsylvania 17837, United States; Recruiting
Russell J Stankiewicz, MD, Phone: 570-523-8700, Ext: 228, Email: rstankiewicz@evanhospital.com
Jennifer L MacDonald, PA, Phone: 5705238700, Ext: 232, Email: jmacdonald@evanhospital.com
Additional Information

Starting date: April 2014
Last updated: August 10, 2015

Page last updated: August 23, 2015

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