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
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