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

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ClinicalTrials.gov Identifier: NCT02517710
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Russell J.Stankiewicz, MD
Ob/GYN Associates of Evangelical Hospital
The Commonwealth Medical College
Nickolas Serniak, BS, MS 4
Neil Cooper, MS, MS 4
Jennifer L. MacDonald, PA
Information provided by (Responsible Party):
Russell J. Stankiewicz, MD, Evangelical Community Hospital, Lewisburg, PA

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

Condition or disease Intervention/treatment Phase
Hysterotomy Closure Procedure: Stratafix synthetic barbed suture Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Placebo Comparator: Control
Group of patients receiving standard hysterotomy closure with synthetic braided suture
Procedure: Stratafix synthetic barbed suture
hysterotomy closure in Cesarian section

Experimental: Stratfix
group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain
Procedure: Stratafix synthetic barbed suture
hysterotomy closure in Cesarian section




Primary Outcome Measures :
  1. Blood loss in closure with barbed synthetic suture [ Time Frame: 2 days ]
    monitoring of preoperative and postoperative hemoglobin and hematcrit


Secondary Outcome Measures :
  1. Post operative pain after cesarean secton [ Time Frame: 3 days ]
    using visual analog pain scale, compare standard closure to barbed suture closure pain


Other Outcome Measures:
  1. time to close uterine hysterotomy incision comparing standard and barbed suture [ Time Frame: total time comparision of closure rates over course of study period (2 years) ]
    comparing time to closure hysterotomy incision of standard suture verse barbed suture



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • General Anesthesia
  • Non-consent to participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517710


Locations
United States, Pennsylvania
Evangelical Community Hospital
Lewisburg, Pennsylvania, United States, 17837
Sponsors and Collaborators
Evangelical Community Hospital, Lewisburg, PA
Russell J.Stankiewicz, MD
Ob/GYN Associates of Evangelical Hospital
The Commonwealth Medical College
Nickolas Serniak, BS, MS 4
Neil Cooper, MS, MS 4
Jennifer L. MacDonald, PA

Responsible Party: Russell J. Stankiewicz, MD, Assistant Clinical professor OB/GYN, Family Medicine, The Commonwealth Medical College, Evangelical Community Hospital, Lewisburg, PA
ClinicalTrials.gov Identifier: NCT02517710     History of Changes
Other Study ID Numbers: ECH/TCMC101
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018