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

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

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

Study Overview

• Status: Completed
• Conditions: Hysterotomy Closure
• Intervention / Treatment: Procedure: Stratafix synthetic barbed suture

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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lewisburg, Pennsylvania, United States, 17837
      • Evangelical Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• General Anesthesia
• Non-consent to participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss in closure with barbed synthetic suture	monitoring of preoperative and postoperative hemoglobin and hematcrit	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain after cesarean secton	using visual analog pain scale, compare standard closure to barbed suture closure pain	3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to close uterine hysterotomy incision comparing standard and barbed suture	comparing time to closure hysterotomy incision of standard suture verse barbed suture	total time comparision of closure rates over course of study period (2 years)

Collaborators and Investigators

• Sponsor: Evangelical Community Hospital, Lewisburg, PA
• 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

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ECH/TCMC101